90 Participants Needed

Walking Program vs Health Education for Chronic Pain

Recruiting at 2 trial locations
JG
Ana-Maria Vranceanu, PhD profile photo
Overseen ByAna-Maria Vranceanu, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you either be free of psychotropic medication for at least 2 weeks before starting or be stable on your current medication for at least 6 weeks and willing to keep the dose stable.

What data supports the effectiveness of the treatment GetActive with Steps! and Healthy Living for Pain for chronic pain?

Research shows that walking programs, like the one in the study, can help people with chronic pain by increasing physical activity and improving pain levels. Additionally, mind-body skills such as mindfulness and pacing, which are part of similar programs, have been found to help increase activity levels in people with chronic pain.12345

Is the walking program safe for people with chronic pain?

The walking program for chronic pain is generally safe, with most adverse events being minor and temporary.26789

How does the treatment 'GetActive with Steps!' differ from other treatments for chronic pain?

The 'GetActive with Steps!' treatment is unique because it combines a walking program with health education to manage chronic pain, promoting physical activity as a primary intervention. Unlike traditional treatments that may focus on rest, this approach encourages gradual increases in physical activity, which can improve overall physical and mental health.610111213

What is the purpose of this trial?

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.

Research Team

Ana-Maria Vranceanu, Ph.D. | Mass ...

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

Owns a smartphone with Bluetooth 4.0 or computer
I am willing and able to follow the study's requirements.
I am not very active, meeting 2 out of 3 low activity criteria.
See 4 more

Exclusion Criteria

My doctor expects my illness to get worse in the next 6 months.
I am unable to walk and use a wheelchair.
You have been using a Fitbit DMD regularly for the past 3 months.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 10-week program, either the mind-body walking program or the health education program, with weekly in-person sessions

10 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-month follow-up assessment

24 weeks
1 visit (in-person) at 6 months

Treatment Details

Interventions

  • GetActive with Steps!
  • Healthy Living for Pain
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Rush University Medical Center

Collaborator

Trials
448
Recruited
247,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Findings from Research

The iPOPP pilot trial aims to assess the feasibility and acceptability of a walking intervention for older adults with chronic musculoskeletal pain, involving 150 participants aged 65 and older over a 12-week follow-up period.
This study will utilize a mixed-methods approach to evaluate the intervention's fidelity and gather insights on barriers and facilitators to behavior change, which will inform the design of a larger randomized controlled trial.
The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol.Healey, EL., Jinks, C., Foster, NE., et al.[2021]
Participants with chronic pain found that receiving reminders significantly improved their adherence to wearing the ActiGraph, which is crucial for accurate activity assessment.
Mind-body skills learned from the activity programs, such as mindfulness and pacing, helped participants increase their activity levels, while ongoing medical issues were identified as barriers to activity.
A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain.Popok, PJ., Greenberg, J., Gates, MV., et al.[2022]
A 10-week walking program integrated into cognitive behavioral therapy for chronic pain significantly increased participants' daily step counts by an average of 1648 steps, indicating its effectiveness in promoting physical activity.
The program was safe, with mostly minor and temporary adverse events reported, and it was equally effective whether delivered in person or via interactive voice response, suggesting flexibility in treatment delivery.
Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention.Heapy, AA., Tankha, H., Higgins, DM., et al.[2023]

References

Effects of a psychoeducational program for chronic pain management. [2019]
The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol. [2021]
A randomized controlled trial investigating effects of an individualized pedometer driven walking program on chronic low back pain. [2023]
Ambulation, activity level, and pain. Outcomes of a program for spinal pain. [2019]
A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. [2022]
Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. [2023]
Adverse events experienced by participants in a back pain walking intervention: A descriptive study. [2016]
Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. [2023]
Experiences, barriers, and facilitators to participating in physical activity and exercise in adults living with chronic pain: a qualitative study. [2021]
Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]
Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. [2023]
Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Revisiting the Provision of Pain Neuroscience Education: An Adjunct Intervention for Patients but a Primary Focus of Clinician Education. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security