Low Back Pain
Conditions
Keywords
Back Pain, Obesity, Aging, Overweight
Brief summary
The central objective of research is to examine the feasibility and acceptability of an 8-month single-arm behavioral intervention (i.e., EMPOWER) among overweight/obese middle-aged and older adults with moderate-to-high impact low back pain. Intervention content will focus on standard behavioral weight loss treatment and cognitive-behavioral pain coping therapy with a focus on environmental reward and positive affect.
Detailed description
Chronic low back pain (cLBP) is the leading cause of disability worldwide and is one of the top reasons for seeking healthcare. High-impact low back pain is particularly problematic, defined as chronic pain accompanied by significant restrictions in work, social, and/or self-care activities for six months or more. High-impact pain is associated with greater pain-related disability, opioid use, and healthcare costs compared to pain of lower impact. Thus, efforts to reduce chronic pain impact have become a public health initiative. Low back pain and overweight/obesity are highly comorbid; overweight and obese individuals are up to 43% more likely to have cLBP compared to normal weight individuals. Together, the additive effects of overweight/obesity and chronic pain may play a larger role in increasing the risk for other adverse health-related comorbidities. The aim of this exploratory study is to examine the feasibility and acceptability of an integrated pain and weight management intervention (EMPOWER) for middle-aged and older adults with moderate-to-high impact low back pain by addressing mechanisms of environmental reward and positive affect. Forty adults (ages 45-80 years) with comorbid overweight/obesity (BMI≥25 kg/m2) and moderate-to-high impact cLBP will be assigned to an 8-month intervention, whereby they will receive a group- and telephone-based program featuring integrated behavioral weight loss treatment and cognitive-behavioral pain coping therapy. To address the key mechanisms of environmental reward and positive affect, the proposed intervention will incorporate systematic pleasant activity scheduling and values-clarification techniques. Assessments will be conducted at baseline and at the 4- and 8-month time points.
Interventions
BEHAVIORALIn-Person (or Remote) Intervention
Participants will be asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
Sponsors
National Institute on Aging (NIA)
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 45-80 years of age * Have a BMI≥25kg/m2 * Endorse pain in the lower back region (i.e., space between the lower posterior margin of the rib cage and the horizontal gluteal fold), knees, or hips * Pain must occur on at least 50% of the days in the previous six months * Pain must be rated, at minimum, of moderate intensity (rating of 3 on a numeric rating scale ranging from 0-10) * Pain impact must be rated as moderate to severe * Study physician reviews medical record and declares patient medically appropriate for exercise protocol
Exclusion criteria
* Current participation in another psychological treatment or structured weight loss program * Severe psychiatric illness not adequately controlled by medication or other conditions anticipated to impair intervention engagement (e.g., substance abuse/dependence) * Presence of chronic, malignant pain (e.g., cancer) * Significant cognitive impairment (\<26) on the Montreal Cognitive Assessment (MoCA) * Inability to read and write English * Currently undergoing radiation or chemotherapy for cancer * Self-reported cardiac event in the past 6 months or self-reported Heart Failure (CHF) * Currently pregnant or breastfeeding, or planning to become pregnant during the study time period * Back, knee, or hip surgery within the past six months of study entry (or planned surgical interventions for pain during forecasted study participation) * If currently taking prescription analgesic or psychotropic medication, must be stabilized on these treatments for \>4 weeks prior to the baseline assessment * Blood pressure higher than 180/100 mm Hg at baseline assessment * Has had bariatric surgery in the past year or is planning to have it in the next year * If participant reports the presence of systemic inflammatory disease (e.g., rheumatoid arthritis), the study physician will be consulted to determine eligibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention | Baseline to 8 Months | Percentage of enrolled participants who complete the 8-month time-point. |
| Session-level Engagement (NOTE: This is a Pilot Study and There is Not a True Primary Outcome. There Are Several Descriptive Outcomes That Will Inform Our Decision to Proceed to a Traditional, Fully Powered Clinical Trial). | Assessed at each session (every other week) up to 8 months | Treatment Engagement Questionnaire: 6-item study-adapted questionnaire assessing perceptions of engagement, interest in the session content, and usefulness of the home activities. Items are rated on a 0 to 8 scale with the mean value across sessions calculated. The total scale is create by taking the mean of the items, and has a possible range of 0 (minimum) to 8 (maximum) score. There are no subscales. Higher scores indicate greater treatment engagement. |
| Global Treatment Engagement | Baseline to 4 months | Number of participants who completed the intervention (defined as attending the final group session) |
| Participant Satisfaction | Month 4 | A single treatment satisfaction item (In an overall, general sense, how satisfied are you with the intervention program you received?). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment. |
| Treatment Credibility | Baseline | Treatment Expectation Questionnaire: 7-item study-developed questionnaire assessing the credibility and reasonableness of the intervention. Items are rated on a 0 to 10 scale. A mean score was calculated for the questionnaire. Higher scores were indicative of greater treatment credibility. |
| Enrollment Rate | Baseline to Week 1 | Percentage of participants who enroll that commence treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Impact Change | 4 months | Research Task Force Impact Stratification Questionnaire: 9-items derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form assessing pain intensity, pain interference with normal activities, and functional status. Impact stratification scores range from 8 (mild impact) to 50 (severe impact), with higher scores indicative of greater pain impact.Score represents change from baseline to 4 month assessment. |
| Pleasant Activity Engagement | Baseline to 8 Months | Percentage of pleasant activity goals met based on standardized self-report at the beginning of each phone session. Participants were queried on whether they achieved their weekly goal with the following response options (yes, no, partially). Frequencies for goal attainment were conducted, with percentage of goals met calculated across participants. |
| Meaningful Activity Participation Change | 4 months | Meaningful Activity Participation Assessment Questionnaire: 28-item checklist reflecting common activities that are meaningful to older adults. Items are rated both for how much time is spent on activities and how meaningful the activities are perceived to be. Items are rated on a 1 to 7 scale for frequency of activities and on a 1 to 5 scale for meaningfulness (summative values calculated). Meaningful Activity Participation Assessment scores can range from 0 to 672. Higher scores indicate greater frequency and meaningfulness of activities. Change from baseline to 4 months |
| Global Treatment Engagement | Baseline to 8 months | Number of participants who completed the intervention (defined as attending the final 8 month treatment session) |
| Body Weight Change | 4 months | Kilograms weight change from baseline to 4 months measured by digital scale |
Countries
United States
Participant flow
Recruitment details
Recruitment for this single-arm clinical trial began in November 2021, with the last participant enrolled in January 2023. Participants with chronic musculoskeletal pain were recruited via the University of Florida Health System's clinical and administrative database. Additionally, patients were approached after their appointments at a a specialty spine clinic, and referrals were made from spine clinic providers. Recruitment took place at UF Health in the Gainesville and Jacksonville area.
Pre-assignment details
Of the 132 individuals who expressed interest in the study and completed prescreening, 37 participants were eligible and enrolled. Of the 37 individuals who were enrolled, 33 participants commenced treatment.
Participants by arm
| Arm | Count |
|---|---|
| Empower Intervention Participants will initially complete a baseline assessment assessing study eligibility. The intervention includes 8 core in-person group sessions and 8 optional in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment content and eight individual phone calls (30 minutes each) focusing primarily on increasing environmental reward and positive affect. Intervention sessions may be delivered online through protected health information (PHI) Zoom. Group sessions were delivered every-other week and phone calls will occur every-other week (during weeks with no group).
Participants were asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 18 |
Baseline characteristics
| Characteristic | Empower Intervention |
|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Enrollment Rate
Number of participants enrolled per week during active recruitment.
Time frame: 63 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empower Intervention | Enrollment Rate | 0.52 participants enrolled per week | Standard Deviation 0.9 |
Primary
Enrollment Rate
Percentage of participants who enroll that commence treatment.
Time frame: Baseline to Week 1
Population: Those who were eligible and consented
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empower Intervention | Enrollment Rate | 33 Participants |
Primary
Global Treatment Engagement
Number of participants who completed the intervention (defined as attending the final group session)
Time frame: Baseline to 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empower Intervention | Global Treatment Engagement | 25 Participants |
Primary
Participant Retention
Percentage of enrolled participants who complete the 8-month time-point.
Time frame: Baseline to 8 Months
Population: All who commence treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empower Intervention | Participant Retention | 19 Participants |
Primary
Participant Satisfaction
A single treatment satisfaction item (In an overall, general sense, how satisfied are you with the intervention program you received?). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment.
Time frame: Month 4
Population: all assessed at 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empower Intervention | Participant Satisfaction | 3.5 units on a scale | Standard Deviation 0.66 |
Primary
Participant Satisfaction
A single treatment satisfaction item (In an overall, general sense, how satisfied are you with the intervention program you received?). This item was rated on a 1 to 4 scale, with a higher score indicating greater satisfaction with the treatment.
Time frame: Month 8
Population: Those completing 8 month assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empower Intervention | Participant Satisfaction | 3.7 score on a scale | Standard Deviation 0.45 |
Primary
Session-level Engagement (NOTE: This is a Pilot Study and There is Not a True Primary Outcome. There Are Several Descriptive Outcomes That Will Inform Our Decision to Proceed to a Traditional, Fully Powered Clinical Trial).
Treatment Engagement Questionnaire: 6-item study-adapted questionnaire assessing perceptions of engagement, interest in the session content, and usefulness of the home activities. Items are rated on a 0 to 8 scale with the mean value across sessions calculated. The total scale is create by taking the mean of the items, and has a possible range of 0 (minimum) to 8 (maximum) score. There are no subscales. Higher scores indicate greater treatment engagement.
Time frame: Assessed at each session (every other week) up to 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empower Intervention | Session-level Engagement (NOTE: This is a Pilot Study and There is Not a True Primary Outcome. There Are Several Descriptive Outcomes That Will Inform Our Decision to Proceed to a Traditional, Fully Powered Clinical Trial). | 6.9 score on a scale | Standard Deviation 1.2 |
Primary
Treatment Credibility
Treatment Expectation Questionnaire: 7-item study-developed questionnaire assessing the credibility and reasonableness of the intervention. Items are rated on a 0 to 10 scale. A mean score was calculated for the questionnaire. Higher scores were indicative of greater treatment credibility.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empower Intervention | Treatment Credibility | 7.8 score on a scale | Standard Deviation 1.3 |
Secondary
Body Weight Change
Kilograms weight change from baseline to 4 months measured by digital scale
Time frame: 4 months
Population: Completed 4 month assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Empower Intervention | Body Weight Change | -2.89 kilograms |
Secondary
Global Treatment Engagement
Number of participants who completed the intervention (defined as attending the final 8 month treatment session)
Time frame: Baseline to 8 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empower Intervention | Global Treatment Engagement | 17 Participants |
Secondary
Meaningful Activity Participation Change
Meaningful Activity Participation Assessment Questionnaire: 28-item checklist reflecting common activities that are meaningful to older adults. Items are rated both for how much time is spent on activities and how meaningful the activities are perceived to be. Items are rated on a 1 to 7 scale for frequency of activities and on a 1 to 5 scale for meaningfulness (summative values calculated). Meaningful Activity Participation Assessment scores can range from 0 to 672. Higher scores indicate greater frequency and meaningfulness of activities. Change from baseline to 4 months
Time frame: 4 months
Population: Those completing 4 month survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Empower Intervention | Meaningful Activity Participation Change | 6.36 score on a scale |
Secondary
Pain Impact Change
Research Task Force Impact Stratification Questionnaire: 9-items derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form assessing pain intensity, pain interference with normal activities, and functional status. Impact stratification scores range from 8 (mild impact) to 50 (severe impact), with higher scores indicative of greater pain impact.Score represents change from baseline to 4 month assessment.
Time frame: 4 months
Population: Those completing 4 month assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Empower Intervention | Pain Impact Change | -4.0 score on a scale |
Secondary
Pleasant Activity Engagement
Percentage of pleasant activity goals met based on standardized self-report at the beginning of each phone session. Participants were queried on whether they achieved their weekly goal with the following response options (yes, no, partially). Frequencies for goal attainment were conducted, with percentage of goals met calculated across participants.
Time frame: Baseline to 8 Months
Population: Percentage of participants meeting partial or full weekly pleasant activity engagement goals.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Empower Intervention | Pleasant Activity Engagement | Full Goals Met | 64.7 percentage of participants |
| Empower Intervention | Pleasant Activity Engagement | Partial Goals Met | 28.0 percentage of participants |