Chronic Low-back Pain
Conditions
Keywords
Chronic Low-back Pain, Acupuncture Therapy
Brief summary
The main goal of the BackInAction research study is to determine the effectiveness of a standard course of acupuncture (15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults (65+ years) with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
Detailed description
Background: A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults (65+ years) with chronic low back pain. Acupuncture has been found to be effective in treating chronic low back pain in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. BackInAction has been designed to address this gap. Purpose: The main goal of BackInAction is to evaluate the effectiveness of a standard course of acupuncture (up to 15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (up to an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference. Design and Outcomes: In this pragmatic, three-arm parallel groups multi-site randomized controlled trial, the investigators will recruit and randomize at least 789 adults ≥ 65 years of age with chronic low back to standard acupuncture, enhanced acupuncture, or usual medical care alone in four health-care systems. These include two integrated health care systems, a fee-for-service system and a network of federally qualified health centers. Primary outcome data will be collected by questionnaire at 3-, 6-, and 12-months post-randomization. In addition, short monthly surveys will capture data on physical function and a composite score of pain intensity and pain interference. Interventions and Duration: Standard acupuncture will consist of 3 months (90 days) of acupuncture needling, with a proposed minimum of 8 treatments and a maximum of 15. Enhanced acupuncture will include the standard acupuncture plus an additional 3-month maintenance period, with a maximum of six additional treatments. Usual medical care will consist of the care that individuals receive according to their insurance benefits plus anything else they pay for out of pocket. The investigators will ask those assigned to usual medical care to avoid acupuncture for the year they are enrolled in the study. Both active treatment arms will also have access to usual medical care. Participants will be enrolled in the study for 12 months. Sample Size and Population: BackInAction will include patients at least 65 years of age with uncomplicated chronic low back pain with or without radiculopathy. The investigators plan to enroll at least 789 participants (263 per study arm). Participants will be recruited from four health plans, with varying numbers of participants from each site. Randomization will be stratified by health care system, age category and gender. The investigators expect the racial and ethnic mix will roughly parallel that of the older Medicare population.
Interventions
PROCEDUREStandard Acupuncture
The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
PROCEDUREEnhanced Acupuncture
The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 65 years of age * Is a current member or patient of the healthcare system * Visited a health care provider for low back pain within the past 12 months * Received primary care at one of the participating health care systems * Has back pain that is uncomplicated with or without radicular pain * Back pain at least 3 months * General activity question from PEG (Pain, Pain Interference with Enjoyment, General Activity scale) at least 3 * Primary care provider provides permission to contact patient * Willing and able to provide consent (Callahan cognitive impairment screener at least 3)
Exclusion criteria
* Specific types of back pain (metastatic cancer or bone cancer or secondary cancers, vertebral fractures, spinal infection, active inflammatory disease) * Low back surgery within past 3 months * Receiving workers compensation or involved in litigation related to chronic low back pain * Acupuncture within the last 6 months * Does not speak or write English or Spanish * Major psychosis, dementia * Current cancer treatment * Red flags of serious underlying illness (a fever most days in the last month; recent unexplained weight loss of 10 lbs or more) * Living in a nursing home, on Hospice, or palliative care * Non-speaking deafness * Non-reliable transportation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Back-related Disability at 6-month Post Randomization (Continuous) | Baseline to 6-month | Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | The MCID is measured by a 30% improvement (reduction) on the Roland Morris Disability Questionnaire Revised (RMDQ-R). The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648. |
| Change in Back-related Disability at 3-, and 12-month (Continuous) | Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in back-related disability is defined as score change in RMDQ, a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 3-months or 12-months would indicate greater improvement. |
| Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in pain intensity and pain interference with enjoyment of life and general activity will be measured by PEG, a 3-item pain-intensity and pain-related interference composite measure assessing pain intensity, and pain interference with enjoyment of life and general activity. Each item is measured by a 0 to 10 scale with 10 indicating greater pain intensity or pain interference. The scores are then averaged with a higher average score indicating greater pain interference/intensity. |
| Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | The MCID is measured by a 30% improvement (reduction) on the PEG. The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648. |
| Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in the Patient-Reported Outcomes Measurement and Information System (PROMIS) Physical functioning short form 6b from the PROMIS-29 (6 items). The 6-item Physical function scale measures self-reported ability to perform activities rather than the actual performance of those activities. Each question has five response options, ranging from one to five. Raw scores range from 6 to 30, with higher scores indicating greater ability. The scores are then standardized using a T-score metric in which 50 is the reference mean and 10 is the standard deviation (SD) of that population. |
| Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months | Patient Global Impression of Change in Overall Pain (1 item). This is a 0 to 6 scale ranging from much worse to much better, with higher scores indicating more improvement. |
| Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews. | Serious adverse events were defined as hospitalizations and deaths. Only potentially treatment-related non-serious adverse events were reported in the acupuncture arms (not usual care). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in PRO scores about the frequency of being anxious or having uncontrollable worry over the past two weeks from the GAD-2, which is part of the PHQ-4. Each item is measured by a 0 to 3 scale with 3 indicating greater anxiety. GAD-2 range is 0-6, with 6 being greater anxiety symptoms. |
| Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in PRO scores about the frequency of depressed mood and anhedonia over the past two weeks from the PHQ-2. Each item is measured by a 0 to 3 scale with 3 indicating greater depression. Total score is 0-6, with 6 indicating greater depression. |
| Change in Fatigue at 3-, 6- and 12-month (Continuous) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in fatigue will be measured by a change in T-score of the 4-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Fatigue Subscale - SF 4a. This PROMIS measure has a T-score with a mean of 50 and a standard deviation of 10, meaning a score of 50 is average. Higher T-scores indicates greater fatigue. PROMIS Fatigue Scoring Manual. Published online November 4, 2016. https://www.fda.gov/media/137977/download |
| Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months | Change in ability to engage in social roles will be measured by the 4-item subscale for ability to participate in social roles in PROMIS. PROMIS measures are standard T-score range of 20-80, with higher scores indicating greater ability to engage in social roles. |
| Change in Sleep Duration at 3-, 6- and 12-month | Study primary outcome timepoint: Baseline to 6 months (sleep duration); Test of Standard Acupuncture: Baseline to 3 months (sleep duration only); Test of Maintenance effect: Baseline to 12 months (sleep duration only) | Change in 1-item sleep duration scale for sleep duration. |
| Change in Sleep Quality | Study primary outcome timepoint: Baseline to 6 months (sleep quality) | Change in sleep quality is measured by the six-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Sleep Disturbance Short Form 6a. The raw computed score has a range of 6-30 with higher scores indicating more sleep disturbance. The raw score is converted to a T-score with mean of 50, standard deviation of 10. Higher T-scores indicate worse sleep quality. PROMIS Sleep Scoring Manual. Published online June 3, 2022. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring\_Manual\_Only/PROMIS\_Sleep\_Scoring\_Manual\_03June2022.pdf |
Countries
United States
Participant flow
Recruitment details
Participants with chronic low back pain that had persisted for \>3 months were recruited from four different health systems. The first participant was enrolled in August 2021 and the last participant was enrolled October 2022.
Pre-assignment details
Of 12,438 participants screened for eligibility, 800 were randomized and enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study. | 266 |
| Standard Acupuncture Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months.
Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. | 265 |
| Enhanced Acupuncture Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months.
Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. | 269 |
| Total | 800 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Dealing with health/life issues | 3 | 4 | 7 |
| Overall Study | Death | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | Privacy concerns | 1 | 0 | 0 |
| Overall Study | Withdrawal by research team | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 24 | 1 | 2 |
Baseline characteristics
| Characteristic | Usual Care | Enhanced Acupuncture | Standard Acupuncture | Total |
|---|---|---|---|---|
| 3+ Days/Week of Exercise 3+ Days of Active Exercise | 145 Participants | 157 Participants | 146 Participants | 448 Participants |
| 3+ Days/Week of Exercise 3+ Days of Low Back Exercise | 95 Participants | 101 Participants | 98 Participants | 294 Participants |
| 3+ Days/Week of Exercise 3+ Days of Other Movement | 25 Participants | 21 Participants | 21 Participants | 67 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 266 Participants | 269 Participants | 265 Participants | 800 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 73.7 Years STANDARD_DEVIATION 6 | 73.8 Years STANDARD_DEVIATION 6.1 | 73.4 Years STANDARD_DEVIATION 5.8 | 73.6 Years STANDARD_DEVIATION 6 |
| Age, Customized 65-74 years old | 157 Participants | 156 Participants | 159 Participants | 472 Participants |
| Age, Customized 75-84 years old | 94 Participants | 98 Participants | 95 Participants | 287 Participants |
| Age, Customized 85+ years old | 15 Participants | 15 Participants | 11 Participants | 41 Participants |
| Any Opioid in Prior 3 Months | 44 Participants | 31 Participants | 35 Participants | 110 Participants |
| BMI Normal (18.5 - <25 kg/m2) | 73 Participants | 85 Participants | 80 Participants | 238 Participants |
| BMI Obese (>=30 kg/m2) | 86 Participants | 82 Participants | 85 Participants | 253 Participants |
| BMI Overweight (25 - <30 kg/m2) | 99 Participants | 93 Participants | 94 Participants | 286 Participants |
| BMI Underweight (<18.5 kg.m2) | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| BMI Mean | 28.4 kg/m^2 STANDARD_DEVIATION 6.4 | 28.0 kg/m^2 STANDARD_DEVIATION 5.9 | 28.1 kg/m^2 STANDARD_DEVIATION 6 | 28.1 kg/m^2 STANDARD_DEVIATION 6.1 |
| Clinical Site IFH | 39 Participants | 42 Participants | 42 Participants | 123 Participants |
| Clinical Site KPNC | 96 Participants | 97 Participants | 93 Participants | 286 Participants |
| Clinical Site KPWA | 62 Participants | 61 Participants | 62 Participants | 185 Participants |
| Clinical Site Sutter | 69 Participants | 69 Participants | 68 Participants | 206 Participants |
| Education At least some college | 147 Participants | 141 Participants | 154 Participants | 442 Participants |
| Education College graduate or higher degree | 86 Participants | 89 Participants | 74 Participants | 249 Participants |
| Education HS Diploma or less | 33 Participants | 38 Participants | 36 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 28 Participants | 33 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 230 Participants | 227 Participants | 217 Participants | 674 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 14 Participants | 15 Participants | 41 Participants |
| Expectations of Acupuncture | 6.36 units on a scale STANDARD_DEVIATION 2.4 | 6.38 units on a scale STANDARD_DEVIATION 2.5 | 6.37 units on a scale STANDARD_DEVIATION 2.4 | 6.37 units on a scale STANDARD_DEVIATION 2.4 |
| Fear Avoidance | 49 Participants | 51 Participants | 50 Participants | 150 Participants |
| Frailty Frailty | 49 Participants | 49 Participants | 58 Participants | 156 Participants |
| Frailty Pre-Frailty | 126 Participants | 128 Participants | 134 Participants | 388 Participants |
| Frailty Robust Health | 82 Participants | 78 Participants | 63 Participants | 223 Participants |
| Frailty Mean | 1.3 units on a scale STANDARD_DEVIATION 1.2 | 1.3 units on a scale STANDARD_DEVIATION 1.2 | 1.5 units on a scale STANDARD_DEVIATION 1.2 | 1.4 units on a scale STANDARD_DEVIATION 1.2 |
| General Anxiety Disorder Subscale of PHQ-4 (GAD 3+) | 53 Participants | 57 Participants | 63 Participants | 173 Participants |
| High Impact Chronic Pain | 112 Participants | 138 Participants | 125 Participants | 375 Participants |
| Household Income $100,000 - $149,999 | 64 Participants | 76 Participants | 72 Participants | 212 Participants |
| Household Income $150,000 or more | 43 Participants | 31 Participants | 30 Participants | 104 Participants |
| Household Income $25,000 - $49,999 | 47 Participants | 35 Participants | 42 Participants | 124 Participants |
| Household Income $50,000 - $99,999 | 77 Participants | 67 Participants | 79 Participants | 223 Participants |
| Household Income Less than $25,000 | 30 Participants | 32 Participants | 37 Participants | 99 Participants |
| How has COVID affected your ability to get healthcare in the last 3 months? Improved your ability to get healthcare | 4 Participants | 7 Participants | 4 Participants | 15 Participants |
| How has COVID affected your ability to get healthcare in the last 3 months? Not affected your ability to get healthcare | 180 Participants | 182 Participants | 181 Participants | 543 Participants |
| How has COVID affected your ability to get healthcare in the last 3 months? Reduced your ability to get healthcare a little | 59 Participants | 61 Participants | 47 Participants | 167 Participants |
| How has COVID affected your ability to get healthcare in the last 3 months? Reduced your ability to get healthcare a lot | 22 Participants | 17 Participants | 31 Participants | 70 Participants |
| How has COVID affected your overall health in the last 3 months? Improved your overall health | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| How has COVID affected your overall health in the last 3 months? Not affected your overall health | 159 Participants | 172 Participants | 152 Participants | 483 Participants |
| How has COVID affected your overall health in the last 3 months? Your overall health is a little worse | 81 Participants | 72 Participants | 85 Participants | 238 Participants |
| How has COVID affected your overall health in the last 3 months? Your overall health is a lot worse | 17 Participants | 19 Participants | 21 Participants | 57 Participants |
| Long-term Opioid Therapy | 14 Participants | 3 Participants | 7 Participants | 24 Participants |
| Married or Domestic Partnered | 156 Participants | 152 Participants | 147 Participants | 455 Participants |
| Medical Morbidity (Elixhauser) | 2.4 units on a scale STANDARD_DEVIATION 1.9 | 2.5 units on a scale STANDARD_DEVIATION 2.1 | 2.6 units on a scale STANDARD_DEVIATION 2.1 | 2.5 units on a scale STANDARD_DEVIATION 2 |
| Mental Health Mood Disorder Diagnosis Anxiety | 46 Participants | 46 Participants | 35 Participants | 127 Participants |
| Mental Health Mood Disorder Diagnosis Depression | 40 Participants | 37 Participants | 42 Participants | 119 Participants |
| Multiple Musculoskeletal Pain Conditions | 224 Participants | 243 Participants | 220 Participants | 687 Participants |
| Number of Musculoskeletal Pain Conditions | 1.6 Number of conditions STANDARD_DEVIATION 1.1 | 1.7 Number of conditions STANDARD_DEVIATION 1 | 1.7 Number of conditions STANDARD_DEVIATION 1.2 | 1.7 Number of conditions STANDARD_DEVIATION 1.1 |
| Pain Catastrophizing | 9.12 units on a scale STANDARD_DEVIATION 5.7 | 9.45 units on a scale STANDARD_DEVIATION 6.1 | 10.77 units on a scale STANDARD_DEVIATION 5.9 | 9.78 units on a scale STANDARD_DEVIATION 5.9 |
| Pain Intensity | 5.73 units on a scale STANDARD_DEVIATION 1.9 | 5.76 units on a scale STANDARD_DEVIATION 2 | 6.06 units on a scale STANDARD_DEVIATION 1.9 | 5.85 units on a scale STANDARD_DEVIATION 2 |
| Pain Limits Work Every Day | 47 Participants | 62 Participants | 52 Participants | 161 Participants |
| Pain Limits Work Most Days | 71 Participants | 78 Participants | 79 Participants | 228 Participants |
| Pain Limits Work Never | 13 Participants | 8 Participants | 12 Participants | 33 Participants |
| Pain Limits Work Some Days | 134 Participants | 120 Participants | 122 Participants | 376 Participants |
| Pain (PEG) | 5.45 units on a scale STANDARD_DEVIATION 2.2 | 5.76 units on a scale STANDARD_DEVIATION 2 | 6.06 units on a scale STANDARD_DEVIATION 1.9 | 5.85 units on a scale STANDARD_DEVIATION 2 |
| Personalized Health Questionnaire-2 (PHQ-2) (depression threshold of 3+) | 51 Participants | 49 Participants | 62 Participants | 162 Participants |
| PROMIS Engagement in Social Roles Subscale | 45.72 units on a scale STANDARD_DEVIATION 8.2 | 45.55 units on a scale STANDARD_DEVIATION 8.5 | 45.14 units on a scale STANDARD_DEVIATION 8.3 | 45.48 units on a scale STANDARD_DEVIATION 8.3 |
| PROMIS Fatigue Subscale | 55.19 units on a scale STANDARD_DEVIATION 8.7 | 54.75 units on a scale STANDARD_DEVIATION 9 | 56.08 units on a scale STANDARD_DEVIATION 9 | 55.34 units on a scale STANDARD_DEVIATION 8.9 |
| PROMIS Physical Function Subscale | 38.31 units on a scale STANDARD_DEVIATION 6.4 | 38.14 units on a scale STANDARD_DEVIATION 6.8 | 38.16 units on a scale STANDARD_DEVIATION 6.5 | 38.2 units on a scale STANDARD_DEVIATION 6.6 |
| PROMIS Sleep Disturbance Subscale | 53.1 units on a scale STANDARD_DEVIATION 8.3 | 53.14 units on a scale STANDARD_DEVIATION 8.1 | 54.63 units on a scale STANDARD_DEVIATION 8.6 | 53.62 units on a scale STANDARD_DEVIATION 8.3 |
| Psychological Counseling Back Pain | 17 Participants | 8 Participants | 10 Participants | 35 Participants |
| Psychological Counseling None | 245 Participants | 253 Participants | 252 Participants | 750 Participants |
| Psychological Counseling Other Needs | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 13 Participants | 16 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants | 43 Participants | 55 Participants | 139 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 21 Participants | 24 Participants | 59 Participants |
| Race (NIH/OMB) White | 187 Participants | 186 Participants | 159 Participants | 532 Participants |
| Received Disability for Lower Back Pain | 29 Participants | 24 Participants | 24 Participants | 77 Participants |
| Roland Morris Disability Questionnaire-Revised | 12.86 units on a scale STANDARD_DEVIATION 5.5 | 13.19 units on a scale STANDARD_DEVIATION 5.5 | 13.49 units on a scale STANDARD_DEVIATION 5.4 | 13.18 units on a scale STANDARD_DEVIATION 5.5 |
| Roland Morris Disability Questionnaire Revised (RMDQ-R) - Back-Related Dysfunction (>=18 score) Roland Score <18 | 207 Participants | 202 Participants | 195 Participants | 604 Participants |
| Roland Morris Disability Questionnaire Revised (RMDQ-R) - Back-Related Dysfunction (>=18 score) Roland Score >=18 | 59 Participants | 67 Participants | 70 Participants | 196 Participants |
| Sciatica | 163 Participants | 195 Participants | 186 Participants | 544 Participants |
| Self-Management Program Back Pain | 23 Participants | 30 Participants | 21 Participants | 74 Participants |
| Self-Management Program None | 234 Participants | 235 Participants | 240 Participants | 709 Participants |
| Self-Management Program Other Needs | 8 Participants | 3 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Female | 167 Participants | 164 Participants | 164 Participants | 495 Participants |
| Sex: Female, Male Male | 99 Participants | 105 Participants | 101 Participants | 305 Participants |
| Sleep Duration | 6.52 hours STANDARD_DEVIATION 1.3 | 6.44 hours STANDARD_DEVIATION 1.4 | 6.35 hours STANDARD_DEVIATION 1.5 | 6.44 hours STANDARD_DEVIATION 1.4 |
| Substance Use Disorder Diagnosis Alcohol use disorder | 3 Participants | 0 Participants | 8 Participants | 11 Participants |
| Substance Use Disorder Diagnosis Cannabis use disorder | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Substance Use Disorder Diagnosis Opioid use disorder | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Substance Use Disorder Diagnosis Other substance use disorder | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Substance Use Disorder Diagnosis Sedative use disorder | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Substance Use Disorder Diagnosis Stimulant use disorder | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Substance Use Disorder Diagnosis Substance use disorder | 6 Participants | 4 Participants | 8 Participants | 18 Participants |
| Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Alcohol Use | 40 Participants | 36 Participants | 38 Participants | 114 Participants |
| Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Illicit Drug Use | 35 Participants | 42 Participants | 30 Participants | 107 Participants |
| Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Prescription Drug Use | 11 Participants | 7 Participants | 6 Participants | 24 Participants |
| Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool TAPS Positive Screen (Any Use) | 86 Participants | 74 Participants | 73 Participants | 233 Participants |
| Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Tobacco Use | 17 Participants | 13 Participants | 19 Participants | 49 Participants |
| Types of Painful Conditions Back pain | 229 Participants | 250 Participants | 228 Participants | 707 Participants |
| Types of Painful Conditions Fibromyalgia | 2 Participants | 5 Participants | 6 Participants | 13 Participants |
| Types of Painful Conditions General pain | 127 Participants | 147 Participants | 134 Participants | 408 Participants |
| Types of Painful Conditions Headache or migraine | 26 Participants | 22 Participants | 19 Participants | 67 Participants |
| Types of Painful Conditions Limb/extremity, joint, and non-systemic, non-inflammatory arthritic pain | 175 Participants | 197 Participants | 176 Participants | 548 Participants |
| Types of Painful Conditions Musculoskeletal chest pain | 36 Participants | 34 Participants | 38 Participants | 108 Participants |
| Types of Painful Conditions Neck pain | 59 Participants | 43 Participants | 60 Participants | 162 Participants |
| Types of Painful Conditions Toothache, ear or jaw pain | 3 Participants | 6 Participants | 8 Participants | 17 Participants |
| Use of Mind-Body Techniques Back Pain | 56 Participants | 57 Participants | 60 Participants | 173 Participants |
| Use of Mind-Body Techniques None | 179 Participants | 178 Participants | 176 Participants | 533 Participants |
| Use of Mind-Body Techniques Other Needs | 29 Participants | 31 Participants | 25 Participants | 85 Participants |
| Use of Online Pain Management Program Back Pain | 7 Participants | 7 Participants | 8 Participants | 22 Participants |
| Use of Online Pain Management Program None | 256 Participants | 258 Participants | 254 Participants | 768 Participants |
| Use of Online Pain Management Program Other Needs | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Use of various types of pain relievers for Back Pain Acetaminophen | 148 Participants | 162 Participants | 174 Participants | 484 Participants |
| Use of various types of pain relievers for Back Pain Cannabis | 50 Participants | 59 Participants | 53 Participants | 162 Participants |
| Use of various types of pain relievers for Back Pain CBD Only | 47 Participants | 42 Participants | 48 Participants | 137 Participants |
| Use of various types of pain relievers for Back Pain Herbal/Nutritional Supplements | 77 Participants | 81 Participants | 61 Participants | 219 Participants |
| Use of various types of pain relievers for Back Pain NSAIDs | 161 Participants | 171 Participants | 155 Participants | 487 Participants |
| Weekly Exercise Active Exercise | 179 Participants | 195 Participants | 190 Participants | 564 Participants |
| Weekly Exercise Low Back Exercise | 116 Participants | 128 Participants | 137 Participants | 381 Participants |
| Weekly Exercise Other Movement | 42 Participants | 47 Participants | 39 Participants | 128 Participants |
| Weekly Exercise (number of days) Weekly active exercise | 3.1 Days STANDARD_DEVIATION 2.7 | 3.25 Days STANDARD_DEVIATION 2.6 | 3.24 Days STANDARD_DEVIATION 2.7 | 3.2 Days STANDARD_DEVIATION 2.7 |
| Weekly Exercise (number of days) Weekly low back exercise | 2.02 Days STANDARD_DEVIATION 2.6 | 2.19 Days STANDARD_DEVIATION 2.7 | 2.13 Days STANDARD_DEVIATION 2.6 | 2.12 Days STANDARD_DEVIATION 2.7 |
| Weekly Exercise (number of days) Weekly other movement | .56 Days STANDARD_DEVIATION 1.6 | .48 Days STANDARD_DEVIATION 1.4 | .42 Days STANDARD_DEVIATION 1.3 | .49 Days STANDARD_DEVIATION 1.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 266 | 0 / 265 | 1 / 269 |
| other Total, other adverse events | 0 / 266 | 24 / 265 | 27 / 269 |
| serious Total, serious adverse events | 18 / 266 | 24 / 265 | 24 / 269 |
Outcome results
Primary
Change in Back-related Disability at 6-month Post Randomization (Continuous)
Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement.
Time frame: Baseline to 6-month
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Change in Back-related Disability at 6-month Post Randomization (Continuous) | -2.1 change in score from baseline on scale |
| Standard Acupuncture | Change in Back-related Disability at 6-month Post Randomization (Continuous) | -3.1 change in score from baseline on scale |
| Enhanced Acupuncture | Change in Back-related Disability at 6-month Post Randomization (Continuous) | -3.6 change in score from baseline on scale |
p-value: 0.02495% CI: [-1.9, -0.1]Wald Test, 2-sided
p-value: 0.00195% CI: [-2.5, -0.6]Wald Test, 2-sided
p-value: 0.28695% CI: [-1.5, 0.5]Wald Test, 2-sided
Secondary
Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary)
The MCID is measured by a 30% improvement (reduction) on the PEG. The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 6 Months | 29.4 adjusted percentage of participants |
| Usual Care | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 3 Months | 23.3 adjusted percentage of participants |
| Usual Care | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 12 Months | 29.5 adjusted percentage of participants |
| Standard Acupuncture | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 6 Months | 35.0 adjusted percentage of participants |
| Standard Acupuncture | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 3 Months | 41.1 adjusted percentage of participants |
| Standard Acupuncture | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 12 Months | 35.9 adjusted percentage of participants |
| Enhanced Acupuncture | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 3 Months | 41.1 adjusted percentage of participants |
| Enhanced Acupuncture | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 12 Months | 35.8 adjusted percentage of participants |
| Enhanced Acupuncture | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | 6 Months | 40.5 adjusted percentage of participants |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 095% CI: [1.39, 2.24]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.1495% CI: [0.94, 1.5]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.00695% CI: [1.1, 1.73]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.16795% CI: [0.94, 1.42]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.08995% CI: [0.97, 1.52]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.1295% CI: [0.95, 1.55]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.9995% CI: [0.8, 1.25]Wald Test, 2-sided
Secondary
Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary)
The MCID is measured by a 30% improvement (reduction) on the Roland Morris Disability Questionnaire Revised (RMDQ-R). The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 6 Months | 29.4 adjusted percentage of participants |
| Usual Care | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 3 Months | 29.9 adjusted percentage of participants |
| Usual Care | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 12 Months | 28.4 adjusted percentage of participants |
| Standard Acupuncture | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 6 Months | 39.1 adjusted percentage of participants |
| Standard Acupuncture | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 3 Months | 42.0 adjusted percentage of participants |
| Standard Acupuncture | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 12 Months | 37.7 adjusted percentage of participants |
| Enhanced Acupuncture | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 3 Months | 42.0 adjusted percentage of participants |
| Enhanced Acupuncture | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 12 Months | 43.8 adjusted percentage of participants |
| Enhanced Acupuncture | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | 6 Months | 43.8 adjusted percentage of participants |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: <0.00195% CI: [1.15, 1.72]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.02295% CI: [1.04, 1.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: <0.00195% CI: [1.19, 1.86]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.3695% CI: [0.88, 1.43]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.01295% CI: [1.06, 1.66]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: <0.00195% CI: [1.25, 1.91]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.07695% CI: [0.98, 1.37]Wald Test, 2-sided
Secondary
Change in Back-related Disability at 3-, and 12-month (Continuous)
Change in back-related disability is defined as score change in RMDQ, a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 3-months or 12-months would indicate greater improvement.
Time frame: Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Back-related Disability at 3-, and 12-month (Continuous) | 3 Months | -2.0 score change from baseline on a scale |
| Usual Care | Change in Back-related Disability at 3-, and 12-month (Continuous) | 12 Months | -1.8 score change from baseline on a scale |
| Standard Acupuncture | Change in Back-related Disability at 3-, and 12-month (Continuous) | 3 Months | -3.4 score change from baseline on a scale |
| Standard Acupuncture | Change in Back-related Disability at 3-, and 12-month (Continuous) | 12 Months | -3.0 score change from baseline on a scale |
| Enhanced Acupuncture | Change in Back-related Disability at 3-, and 12-month (Continuous) | 3 Months | -3.4 score change from baseline on a scale |
| Enhanced Acupuncture | Change in Back-related Disability at 3-, and 12-month (Continuous) | 12 Months | -3.5 score change from baseline on a scale |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 095% CI: [-2.1, -0.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.00895% CI: [-2.1, -0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 095% CI: [-2.6, -0.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.2795% CI: [-1.4, 0.4]Wald Test, 2-sided
Secondary
Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous)
Change in pain intensity and pain interference with enjoyment of life and general activity will be measured by PEG, a 3-item pain-intensity and pain-related interference composite measure assessing pain intensity, and pain interference with enjoyment of life and general activity. Each item is measured by a 0 to 10 scale with 10 indicating greater pain intensity or pain interference. The scores are then averaged with a higher average score indicating greater pain interference/intensity.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 6 Months | -0.6 change of score from baseline on a scale |
| Usual Care | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 3 Months | -0.6 change of score from baseline on a scale |
| Usual Care | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 12 Months | -0.7 change of score from baseline on a scale |
| Standard Acupuncture | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 6 Months | -1.1 change of score from baseline on a scale |
| Standard Acupuncture | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 3 Months | -1.4 change of score from baseline on a scale |
| Standard Acupuncture | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 12 Months | -1.1 change of score from baseline on a scale |
| Enhanced Acupuncture | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 3 Months | -1.4 change of score from baseline on a scale |
| Enhanced Acupuncture | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 12 Months | -1.3 change of score from baseline on a scale |
| Enhanced Acupuncture | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | 6 Months | -1.5 change of score from baseline on a scale |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 095% CI: [-1.1, -0.5]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.01995% CI: [-0.8, -0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 095% CI: [-1.3, -0.6]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.0295% CI: [-0.9, -0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.0295% CI: [-0.8, -0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 095% CI: [-1, -0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.2295% CI: [-0.6, 0.1]Wald Test, 2-sided
Secondary
Change in Physical Functioning at 3-, 6- and 12-month (Continuous)
Change in the Patient-Reported Outcomes Measurement and Information System (PROMIS) Physical functioning short form 6b from the PROMIS-29 (6 items). The 6-item Physical function scale measures self-reported ability to perform activities rather than the actual performance of those activities. Each question has five response options, ranging from one to five. Raw scores range from 6 to 30, with higher scores indicating greater ability. The scores are then standardized using a T-score metric in which 50 is the reference mean and 10 is the standard deviation (SD) of that population.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 6 Months | 1.0 change in score from baseline on a scale |
| Usual Care | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 3 Months | 0.8 change in score from baseline on a scale |
| Usual Care | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 12 Months | 1.0 change in score from baseline on a scale |
| Standard Acupuncture | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 6 Months | 1.2 change in score from baseline on a scale |
| Standard Acupuncture | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 3 Months | 1.6 change in score from baseline on a scale |
| Standard Acupuncture | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 12 Months | 1.7 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 3 Months | 1.6 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 12 Months | 1.5 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | 6 Months | 1.8 change in score from baseline on a scale |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 0.02595% CI: [0.1, 1.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.74795% CI: [-0.8, 1.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.195% CI: [-0.1, 1.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.2295% CI: [-0.4, 1.6]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.16295% CI: [-0.3, 1.6]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.27795% CI: [-0.4, 1.4]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.6895% CI: [-1, 0.7]Wald Test, 2-sided
Secondary
Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months
Patient Global Impression of Change in Overall Pain (1 item). This is a 0 to 6 scale ranging from much worse to much better, with higher scores indicating more improvement.
Time frame: Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 6 Months | 3.3 Change in score from baseline on a scale |
| Usual Care | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 3 Months | 3.4 Change in score from baseline on a scale |
| Usual Care | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 12 Months | 3.3 Change in score from baseline on a scale |
| Standard Acupuncture | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 6 Months | 4.0 Change in score from baseline on a scale |
| Standard Acupuncture | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 3 Months | 4.5 Change in score from baseline on a scale |
| Standard Acupuncture | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 12 Months | 3.9 Change in score from baseline on a scale |
| Enhanced Acupuncture | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 3 Months | 4.5 Change in score from baseline on a scale |
| Enhanced Acupuncture | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 12 Months | 4.1 Change in score from baseline on a scale |
| Enhanced Acupuncture | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | 6 Months | 4.6 Change in score from baseline on a scale |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 095% CI: [0.9, 1.4]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 095% CI: [0.4, 1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 095% CI: [1, 1.5]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 095% CI: [0.3, 0.9]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 095% CI: [0.2, 0.8]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 095% CI: [0.5, 1.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.0695% CI: [0, 0.5]Wald Test, 2-sided
Secondary
Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE)
Serious adverse events were defined as hospitalizations and deaths. Only potentially treatment-related non-serious adverse events were reported in the acupuncture arms (not usual care).
Time frame: SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Serious Adverse Events (SAEs) | 18 events |
| Usual Care | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Adverse Events (AEs) | 0 events |
| Standard Acupuncture | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Serious Adverse Events (SAEs) | 24 events |
| Standard Acupuncture | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Adverse Events (AEs) | 24 events |
| Enhanced Acupuncture | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Serious Adverse Events (SAEs) | 24 events |
| Enhanced Acupuncture | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Adverse Events (AEs) | 27 events |
Other Pre-specified
Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous)
Change in ability to engage in social roles will be measured by the 4-item subscale for ability to participate in social roles in PROMIS. PROMIS measures are standard T-score range of 20-80, with higher scores indicating greater ability to engage in social roles.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 6 Months | 0.5 change in score from baseline on a scale |
| Usual Care | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 3 Months | 0.4 change in score from baseline on a scale |
| Usual Care | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 12 Months | -0.2 change in score from baseline on a scale |
| Standard Acupuncture | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 6 Months | 1.3 change in score from baseline on a scale |
| Standard Acupuncture | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 3 Months | 1.6 change in score from baseline on a scale |
| Standard Acupuncture | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 12 Months | 1.6 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 3 Months | 1.6 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 12 Months | 1.4 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | 6 Months | 1.6 change in score from baseline on a scale |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 0.02395% CI: [0.2, 2.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.18695% CI: [-0.4, 2]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.10795% CI: [-0.2, 2.5]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.65195% CI: [-1, 1.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.00195% CI: [0.7, 2.9]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.00795% CI: [0.4, 2.7]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.65695% CI: [-1.2, 0.8]Wald Test, 2-sided
Other Pre-specified
Change in Fatigue at 3-, 6- and 12-month (Continuous)
Change in fatigue will be measured by a change in T-score of the 4-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Fatigue Subscale - SF 4a. This PROMIS measure has a T-score with a mean of 50 and a standard deviation of 10, meaning a score of 50 is average. Higher T-scores indicates greater fatigue. PROMIS Fatigue Scoring Manual. Published online November 4, 2016. https://www.fda.gov/media/137977/download
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 6 Months | -1.55 change in T-score from baseline |
| Usual Care | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 3 Months | -2.42 change in T-score from baseline |
| Usual Care | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 12 Months | -1.18 change in T-score from baseline |
| Standard Acupuncture | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 6 Months | -2.06 change in T-score from baseline |
| Standard Acupuncture | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 3 Months | -3.27 change in T-score from baseline |
| Standard Acupuncture | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 12 Months | -2.47 change in T-score from baseline |
| Enhanced Acupuncture | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 3 Months | -3.27 change in T-score from baseline |
| Enhanced Acupuncture | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 12 Months | -3.50 change in T-score from baseline |
| Enhanced Acupuncture | Change in Fatigue at 3-, 6- and 12-month (Continuous) | 6 Months | -2.52 change in T-score from baseline |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 0.19495% CI: [-2.1, 0.4]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.5195% CI: [-2, 1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.21895% CI: [-2.5, 0.6]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.6295% CI: [-2.3, 1.4]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.0795% CI: [-2.7, 0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 095% CI: [-3.6, -1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.08695% CI: [-2.2, 0.1]Wald Test, 2-sided
Other Pre-specified
Change in Sleep Duration at 3-, 6- and 12-month
Change in 1-item sleep duration scale for sleep duration.
Time frame: Study primary outcome timepoint: Baseline to 6 months (sleep duration); Test of Standard Acupuncture: Baseline to 3 months (sleep duration only); Test of Maintenance effect: Baseline to 12 months (sleep duration only)
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Sleep Duration at 3-, 6- and 12-month | 6 Months | 0.02 change in hours from baseline |
| Usual Care | Change in Sleep Duration at 3-, 6- and 12-month | 3 Months | 0.17 change in hours from baseline |
| Usual Care | Change in Sleep Duration at 3-, 6- and 12-month | 12 Months | 0.13 change in hours from baseline |
| Standard Acupuncture | Change in Sleep Duration at 3-, 6- and 12-month | 6 Months | 0.12 change in hours from baseline |
| Standard Acupuncture | Change in Sleep Duration at 3-, 6- and 12-month | 3 Months | 0.17 change in hours from baseline |
| Standard Acupuncture | Change in Sleep Duration at 3-, 6- and 12-month | 12 Months | 0.18 change in hours from baseline |
| Enhanced Acupuncture | Change in Sleep Duration at 3-, 6- and 12-month | 3 Months | 0.17 change in hours from baseline |
| Enhanced Acupuncture | Change in Sleep Duration at 3-, 6- and 12-month | 12 Months | 0.27 change in hours from baseline |
| Enhanced Acupuncture | Change in Sleep Duration at 3-, 6- and 12-month | 6 Months | 0.2 change in hours from baseline |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 0.96795% CI: [-0.02, 0.02]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.27295% CI: [-0.1, 0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.04995% CI: [0, 0.4]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.40995% CI: [-0.1, 0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.6295% CI: [-0.1, 0.2]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.12195% CI: [0, 0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.2795% CI: [-0.1, 0.2]Wald Test, 2-sided
Other Pre-specified
Change in Sleep Quality
Change in sleep quality is measured by the six-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Sleep Disturbance Short Form 6a. The raw computed score has a range of 6-30 with higher scores indicating more sleep disturbance. The raw score is converted to a T-score with mean of 50, standard deviation of 10. Higher T-scores indicate worse sleep quality. PROMIS Sleep Scoring Manual. Published online June 3, 2022. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring\_Manual\_Only/PROMIS\_Sleep\_Scoring\_Manual\_03June2022.pdf
Time frame: Study primary outcome timepoint: Baseline to 6 months (sleep quality)
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Usual Care | Change in Sleep Quality | -1.18 Change in T-score from baseline |
| Standard Acupuncture | Change in Sleep Quality | -1.62 Change in T-score from baseline |
| Enhanced Acupuncture | Change in Sleep Quality | -2.19 Change in T-score from baseline |
Comparison: Difference in change from baseline at 6 monthsp-value: -0.0695% CI: [-1.7, 0.08]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: -0.1595% CI: [-2.4, 0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.38795% CI: [-1.9, 0.7]Wald Test, 2-sided
Other Pre-specified
Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous)
Change in PRO scores about the frequency of being anxious or having uncontrollable worry over the past two weeks from the GAD-2, which is part of the PHQ-4. Each item is measured by a 0 to 3 scale with 3 indicating greater anxiety. GAD-2 range is 0-6, with 6 being greater anxiety symptoms.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 6 Months | 0.1 change in score from baseline on a scale |
| Usual Care | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 3 Months | 0.0 change in score from baseline on a scale |
| Usual Care | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 12 Months | 0.0 change in score from baseline on a scale |
| Standard Acupuncture | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 6 Months | -0.3 change in score from baseline on a scale |
| Standard Acupuncture | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 3 Months | -0.2 change in score from baseline on a scale |
| Standard Acupuncture | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 12 Months | -0.4 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 3 Months | -0.2 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 12 Months | -0.3 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | 6 Months | -0.2 change in score from baseline on a scale |
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 0.06995% CI: [-0.4, 0.02]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.01395% CI: [-0.6, -0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.04395% CI: [-0.5, -0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.62995% CI: [-0.2, 0.3]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.00195% CI: [-0.6, -0.2]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.01995% CI: [-0.5, -0.05]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.27195% CI: [-0.1, 0.3]Wald Test, 2-sided
Other Pre-specified
Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous)
Change in PRO scores about the frequency of depressed mood and anhedonia over the past two weeks from the PHQ-2. Each item is measured by a 0 to 3 scale with 3 indicating greater depression. Total score is 0-6, with 6 indicating greater depression.
Time frame: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months
Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Usual Care | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 6 Months | 0.0 change in score from baseline on a scale |
| Usual Care | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 3 Months | 0.0 change in score from baseline on a scale |
| Usual Care | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 12 Months | -0.2 change in score from baseline on a scale |
| Standard Acupuncture | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 6 Months | -0.2 change in score from baseline on a scale |
| Standard Acupuncture | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 3 Months | -0.2 change in score from baseline on a scale |
| Standard Acupuncture | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 12 Months | -0.4 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 3 Months | -0.2 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 12 Months | -0.3 change in score from baseline on a scale |
| Enhanced Acupuncture | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | 6 Months | -0.3 change in score from baseline on a scale |
Comparison: Difference in change from baseline at 12 monthsp-value: 0.16395% CI: [-0.4, 0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 3 months; SA \& EA are pooled because 3 months is considered standard acupuncture regardless of acupuncture treatment arm.p-value: 0.19195% CI: [-0.3, 0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.03895% CI: [-0.5, -0.01]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.01995% CI: [-0.5, -0.05]Wald Test, 2-sided
Comparison: Difference in change from baseline at 6 monthsp-value: 0.80395% CI: [-0.2, 0.2]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.62595% CI: [-0.2, 0.1]Wald Test, 2-sided
Comparison: Difference in change from baseline at 12 monthsp-value: 0.19895% CI: [-0.1, 0.3]Wald Test, 2-sided