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Not Yet Recruiting
NCT05700383
Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain; Multi-site Feasibility RCT
Conditions: Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: Massachusetts General Hospital
Summary
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain.
The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks.
Both programs will be delivered in-person.
Eligibility Criteria
Inclusion Criteria:Male and female outpatients, age 18 years or olderHave nonmalignant chronic musculoskeletal pain for more than 3 monthsAble to perform a 6-minute walk test (6MWT)Owns a smartphone with Bluetooth 4.0 or computerWillingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocolFree of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable doseCleared by a medical doctor for study participationSedentary, as assessed by meeting at least 2 of the following 3 self-reported criteria:sitting for more than 8 hours/dayNot engaged in >30 min/day exercise 3 or more times/week for the past monthNot walking > 30 minutes/day for the past monthExclusion Criteria:Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)Serious mental illness or instability for which hospitalization may be likely in the next 6 monthsCurrent suicidal ideation reported on self-reportLifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, current substance abuse or dependenceCurrent substance abuse or dependence, and current alcohol dependence within the past 6 monthsPractice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >30 min 3 times/week within the last 3 months or less.
Regular use of Fitbit DMD in the last 3 months.Unable to walk/in a wheelchairMild cognitive decline (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors)
Source: ClinicalTrials.gov (NCT05700383). StuddyBuddy aggregates publicly available trial information.