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Walking Program vs Health Education for Chronic Pain

N/A

Waitlist Available

Led By Ana-Maria Vranceanu, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to perform a 6-minute walk test (6MWT)

Have nonmalignant chronic musculoskeletal pain for more than 3 months

Must not have

Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)

Unable to walk/in a wheelchair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a walking program can help people with chronic pain, compared to a health-ed program. Both will be delivered in person.

Who is the study for?

Adults over 18 with chronic musculoskeletal pain, low activity levels, and the ability to walk can join this study. They must be fluent in English, own a smartphone or computer, and either not take psychotropic meds or have been stable on them for 6 weeks. Excluded are those with serious mental illness, substance abuse issues, regular mind-body practice users, severe medical conditions expected to worsen soon, suicidal thoughts or certain cognitive impairments.

What is being tested?

The trial is testing two programs: a 'mind-body walking program' using GetActive-Fitbit versus a 'health education program' called Healthy Living for Pain. The goal is to see which one works better for people with chronic pain. Participants will be randomly placed into one of these two groups.

What are the potential side effects?

Since the interventions involve physical activity and educational programs rather than medications, side effects may include typical exercise-related discomfort such as muscle soreness or strain but should generally be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk for 6 minutes without assistance.

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I have had chronic pain in my muscles or bones for over 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My doctor expects my illness to get worse in the next 6 months.

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I am unable to walk and use a wheelchair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Accelerometer

Assessment feasibility

Client Satisfaction Scale

+6 more

Secondary study objectives

6 Minute Walk Test (6MWT)

ActiGraph GT9X

Cognitive and Affective Mindfulness Scale (CAMS)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GetActive-FitbitExperimental Treatment1 Intervention

GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.

Group II: Healthy Living for PainActive Control1 Intervention

Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.

0 / 4Eligibility criteria met