Chronic Pain, Low Back Pain
Conditions
Keywords
Physical Therapy, Cognitive Behavioral Therapy, Mindfulness, Adaptive Treatment Regimens
Brief summary
The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.
Detailed description
The study uses a sequential multiple randomization (SMART) design. The study will compare the effectiveness of common first-line treatments for chronic LBP: PT or CBT. Initial treatment will be 8 weeks duration with re-evaluation at 10-weeks after enrollment to allow time to complete treatment. At the 10-week assessment researchers will examine if the patient has responded to initial treatment using a patient-centered, validated definition of successful response based on 50% improvement in the Oswestry Disability Index (ODI). Patients who are responders to initial treatment will receive up to 2 additional sessions of the same treatment to assist transition to self-management. Non-responders will be re-randomized to a second treatment strategy of either switching to the other initial treatment (i.e., patients receiving PT switch to CBT or vice versa), or mindfulness. The second treatment phase is also 8 weeks in duration. Additional follow-ups occur 26- and 52 weeks after enrollment. The study has two co-primary outcomes; function and pain. The investigators will use the ODI, a well-validated, reliable and responsive patient-reported measure of LBP-related function recommended by the NIH Back Pain Task Force. The investigators will assess pain intensity with 0-10 ratings ('0' indicating no pain and '10' worst imaginable pain). Separate ratings are made for current, worst and best pain over the past 24 hours with an average computed to represent pain intensity. Secondary outcomes will assess dimensions of quality of life, work and healthcare utilization.
Interventions
BEHAVIORALPhysical Therapy
Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
BEHAVIORALCognitive Behavioral Therapy
Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction
BEHAVIORALMindfulness
Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
BEHAVIORALPhase I Treatment
Includes all participants receiving any Phase I intervention
BEHAVIORALPhase II Switching
Includes all participants receiving Switching as Phase II intervention
Sponsors
University of Utah
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants and clinicians cannot be blind to treatment received. The investigators will remain blind to group assignment and follow-up assessments will be conducted by assessors who are blind to treatment group.
Intervention model description
Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 64 years at the time of enrollment. * Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP. * Healthcare visit for LBP in the past 90 days. * At least moderate levels of pain and disability requiring ODI score \>24 and pain intensity rating \> 4. * Has access to two-way video technology, such as smartphone, iPad/tablet, or laptop with webcam for telehealth visits.
Exclusion criteria
* Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc. * Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc. * Knowingly pregnant * Has received physical therapy for LBP; or CBT or mindfulness for any reason with a provider in prior 90 days * Currently receiving substance use disorder treatment * Any lumbar spine surgery in the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index From Baseline to 10 Weeks | baseline, 10 weeks | Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability |
| Change in Oswestry Disability Index From 10-weeks to 52 Weeks | 10 weeks, 52 weeks | Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability |
| Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks | baseline, 10 weeks | 0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity. |
| Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks | 10 weeks, 52 weeks | 0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Disturbance From Baseline to 10 Weeks | baseline, 10 weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in sleep disturbance |
| Change in Depression From Baseline to 10 Weeks | baseline, 10 weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in depression |
| Change in Social Role Participation From Baseline to 10 Weeks | baseline, 10 weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in the ability to perform social roles |
| Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks | baseline, 10 weeks | Use of either MRI or CT for low back pain |
| Opioid Utilization at 10-week Assessment | baseline, 10 weeks | Long-term use of opioids for pain management defined as use on all or most days in the past 90 days |
| Treatment Side Effects | 10 weeks | Self-reported physical or psychological side effects of study treatments |
| Treatment Responder | baseline, 10 weeks | Dichotomous outcome based on achieving at least 50% improvement on ODI from baseline score |
| Health Care Utilization of Injections for Back Pain Over 10 Weeks | baseline, 10 weeks | Use of injections for low back pain |
| Change in Anxiety From Baseline to 10 Weeks | baseline, 10 weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29)assessed as a T-score with mean = 50 and SD = 10. Negative values indicate improvement in anxiety |
| Health Care Utilization of Radiographs for Back Pain Over 10 Weeks | baseline, 10 weeks | Use of radiographs for low back pain |
| Health-related Quality of Life | baseline, 10 weeks, 26 weeks, 52 weeks | PROMIS-29 subscales scores reported across 7 domains |
| Change in Pain Interference From Baseline to 10 Weeks | baseline, 10 weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. negative scores indicate improvement in pain interference. |
| Change in Fatigue From Baseline to !0 Weeks | baseline, 10 weeks | Patient-Reported Outcomes Information System (PROMIS) 4-item short form (part of PROMIS-29) assessed as a T-score with mean = 50 and SD = 10. Negative values indicate greater improvement in fatigue. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulie Fritz, PT, PhD
University of Utah
Participant flow
Recruitment details
Trial enrollment began in March, 2019. In March, 2020 the trial suspended enrollments across all sites due to COVID restrictions. Enrollment resumed in April, 2021 and was completed in September, 2023.
Pre-assignment details
A total 751 participants were randomized. Three participants were determined to be false inclusions after randomization. One false inclusion was the result of not meeting the minimum disability threshold for eligibility. This participant continued in the study. The other two false inclusions were persons with medical conditions that were exclusions. These two participants did not participate in the study. Therefore study results are reported for 749 participants.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.5 Years STANDARD_DEVIATION 11.8 |
| Body Mass Index | 32.3 kg/m2 STANDARD_DEVIATION 8.8 |
| Current Smoker | 48 Participants |
| Duration of Opioid Use at Baseline > 1 year | 38 Participants |
| Duration of Opioid Use at Baseline <30 days | 13 Participants |
| Duration of Opioid Use at Baseline 30 days - 1 year | 25 Participants |
| Duration of Opioid Use at Baseline None | 307 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 342 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Highest Education Level Completed Completed College Degree | 406 Participants |
| Highest Education Level Completed Completed High School | 139 Participants |
| Highest Education Level Completed Less Than High School | 40 Participants |
| Leg Pain with Back Pain | 91 Participants |
| Numeric Pain Intensity Rating | 5.6 units on a scale STANDARD_DEVIATION 1.8 |
| Oswestry Disability Index | 41.2 units on a scale STANDARD_DEVIATION 12.8 |
| Patient-reported outcomes measurement information system (PROMIS) - anxiety | 54.5 T score STANDARD_DEVIATION 10.3 |
| Patient-reported outcomes measurement information system (PROMIS) - depression | 52.5 T score STANDARD_DEVIATION 10.3 |
| Patient-reported outcomes measurement information system (PROMIS) - fatigue | 57.5 T score STANDARD_DEVIATION 9.4 |
| Patient-reported outcomes measurement information system (PROMIS) - pain interference | 63.3 T score STANDARD_DEVIATION 5.8 |
| Patient-reported outcomes measurement information system (PROMIS) - physical function | 38.5 T score STANDARD_DEVIATION 5.2 |
| Patient-reported outcomes measurement information system (PROMIS) - sleep disturbance | 56.4 T score STANDARD_DEVIATION 7.7 |
| Patient-reported outcomes measurement information system (PROMIS) - social roles | 44.7 T score STANDARD_DEVIATION 6.5 |
| Prior Lumbar Spine Surgery | 99 Participants |
| Provided Opioids at Index Healthcare Visit | 78 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 142 Participants |
| Race (NIH/OMB) More than one race | 25 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 257 Participants |
| Sex/Gender, Customized Female | 473 Participants |
| Sex/Gender, Customized Male | 137 Participants |
| Sex/Gender, Customized Missing or Other | 2 Participants |
| Time From First Low Back Pain Episode >10 years ago | 167 Participants |
| Time From First Low Back Pain Episode 1-5 years ago | 95 Participants |
| Time From First Low Back Pain Episode < 1 year ago | 40 Participants |
| Time From First Low Back Pain Episode 6-10 years ago | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 374 | 0 / 375 | 0 / 103 | 0 / 110 | 0 / 197 |
| other Total, other adverse events | 0 / 374 | 0 / 375 | 0 / 103 | 0 / 110 | 0 / 197 |
| serious Total, serious adverse events | 9 / 374 | 12 / 375 | 2 / 103 | 3 / 110 | 11 / 197 |
Outcome results
None listed