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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can walk for 6 minutes without assistance.
Select...
I have had chronic pain in my muscles or bones for over 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to Accelerometer
Assessment feasibility
Client Satisfaction Scale
+6 moreSecondary outcome measures
6 Minute Walk Test (6MWT)
ActiGraph GT9X
Cognitive and Affective Mindfulness Scale (CAMS)
+8 moreTrial 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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,391 Total Patients Enrolled
30 Trials studying Chronic Pain
4,923 Patients Enrolled for Chronic Pain
Rush University Medical CenterOTHER
422 Previous Clinical Trials
163,411 Total Patients Enrolled
7 Trials studying Chronic Pain
1,522 Patients Enrolled for Chronic Pain
Duke UniversityOTHER
2,363 Previous Clinical Trials
3,420,396 Total Patients Enrolled
22 Trials studying Chronic Pain
11,043 Patients Enrolled for Chronic Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of this clinical trial's participant pool?
"To reach the study's full potential, 90 volunteers who meet the prerequisites must take part in this investigation. Participants may register at Massachusetts General Hospital in Boston or Duke University in Durham, North carolina."
Answered by AI
Are there any available vacancies for this clinical trial?
"Affirmative. According to information shared on clinicaltrials.gov, this trial has been posted since April 1st 2023 and last updated in October 17th of the same year. As many as 90 individuals must be recruited from three distinct sites for this research study."
Answered by AI
What is the ultimate aim of this research endeavor?
"The principal goal of this clinical study, assessed over a 1 Year period, is to determine the feasibility of recruiting racial and ethnic minorities. Secondary objectives involve measuring PROMIS Depression v1.08b (to gauge negative moods), PROMIS Anxiety v1.08a (which evaluates fear/worry levels), as well as Pain Catastrophizing Scale scores (utilised to quantify helplessness due to pain)."
Answered by AI
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