EMPOWER: Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward

Low Back Pain Clinical Trial

Official title:

Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04851587
• Other study ID #: IRB202002133-N
• Secondary ID: 1R21AG070642-01
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: Kasey Page, B.S
• Phone: 352-273-8798
• Email: kpage[@]dental.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Obesity

Intervention

Behavioral:
• In-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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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. Higher scores indicate greater treatment engagement.	Baseline to 8 months
Primary	Global Treatment Engagement	Percentage of participants who attend intervention sessions, defined as =80% attendance at sessions overall, and =70 attendance at both group and phone sessions considered separately.	Baseline to 8 months
Primary	Participant Satisfaction	8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.	Month 4
Primary	Participant Satisfaction	8-item Client Satisfaction Questionnaire: Response to self-reported quality of the treatment, willingness to recommend the treatment, and general satisfaction with the treatment. Items are rated on a 1 to 4 scale with the mean value calculated. Higher scores indicate greater satisfaction with the treatment.	Month 8
Primary	Treatment Credibility	Treatment Expectation Questionnaire: 7-item study-adapted questionnaire assessing the credibility and reasonableness of the intervention, and expectation for change in pain and weight. Items are rated on a 0 to 10 scale or a 0% to 100% scale. Higher scores indicate greater treatment credibility and expectation for improvement.	Baseline
Primary	Enrollment Rate	Percentage of participants who enroll that commence treatment.	Baseline to Week 1
Primary	Recruitment Rate	Percentage of participants enrolled per week during active recruitment.	Baseline to 8 Months
Primary	Participant Retention	Percentage of enrolled participants who complete the 8-month time-point.	Baseline to 8 Months
Secondary	Body Weight	Percentage of body weight reduction as measured in kilograms by digital scale	Baseline, 4 months, 8 months
Secondary	Pain Impact	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.	Baseline, 4 months, 8 months
Secondary	Pleasant Activity Engagement	Percentage of pleasant activity goals met based on standardized self-report at the beginning of each phone session.	Baseline to 8 Months
Secondary	Meaningful Activity Participation	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). Higher scores indicate greater frequency and meaningfulness of activities.	Baseline, 4 months, 8 months