Walking Program vs Health Education for Chronic Pain

No longer recruiting at 2 trial locations

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropics

Disqualifiers: Serious mental illness, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two programs designed to help people with chronic musculoskeletal pain. The first program, "GetActive with Steps!", emphasizes walking and mind-body skills such as mindfulness and setting step goals. The second, "Healthy Living for Pain", provides health education on sleep, nutrition, and pain management. This trial suits individuals who have experienced non-cancer-related musculoskeletal pain for over three months, are mostly inactive, and can walk for six minutes at a time. As an unphased trial, it offers a unique opportunity to explore innovative approaches to pain management and improve participants' quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the mind-body walking program, GetActive-Fitbit, is safe according to previous studies. It includes activities like mindfulness, deep breathing, and walking, which most people manage well. Earlier research indicated that participants experienced lasting improvements in physical function without major side effects.

The Healthy Living for Pain program is an educational course covering topics such as nutrition, sleep, and physical activity. Based on a well-known program, it focuses on providing detailed information rather than physical exercises. This type of program typically carries a low risk of side effects because it mainly involves learning and discussion.

Both programs are designed to be safe and supportive for people with chronic pain. They aim for gradual improvements and skill-building, which helps reduce potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to managing chronic musculoskeletal pain. Unlike standard care options that often rely heavily on medication or passive therapies, the GetActive-Fitbit program focuses on empowering individuals through mind-body techniques and physical activity. It uniquely combines mindfulness, deep breathing, and cognitive strategies with personalized walking goals, providing a holistic way to improve both mental and physical well-being. The Healthy Living for Pain program, on the other hand, offers comprehensive education on managing pain through lifestyle changes, covering crucial topics like sleep, nutrition, and social connections. These programs aim to equip patients with practical skills to take an active role in their pain management, potentially leading to more sustainable and empowering outcomes.

What evidence suggests that this trial's programs could be effective for chronic pain?

Research shows that physical activity, like walking, can help people with chronic pain feel and move better. In this trial, participants will join one of two programs. The GetActive-Fitbit program, one study arm, combines walking with techniques like mindfulness and deep breathing, and it has shown positive results. Studies suggest this program improves both movement and emotional well-being for those with chronic musculoskeletal pain. Participants have reported ongoing improvements in daily activities and pain management. Meanwhile, the Healthy Living for Pain program, another study arm, provides information on managing pain, improving sleep, eating well, and building social connections. Both programs aim to help people with chronic pain live healthier, more active lives. ^{1 2 3 4 6}

Who Is on the Research Team?

Ana-Maria Vranceanu, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: GetActive-Fitbit Experimental Treatment 1 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 Pain Active Control 1 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.

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+

Published Research Related to This Trial

Exercise and movement should be prioritized as the main intervention for managing chronic pain, rather than relying solely on pain neuroscience education (PNE) or other therapies.

PNE should be used as a supportive tool to encourage increased participation in exercise, as enhancing knowledge and skills in pain management can lead to better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting the Provision of Pain Neuroscience Education: An Adjunct Intervention for Patients but a Primary Focus of Clinician Education. Louw, A., Sluka, KA., Nijs, J., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 21 studies involving 37,143 participants found that physical activity and exercise can lead to small-to-moderate improvements in pain severity and physical function for adults with chronic pain, although results were inconsistent across different interventions.

The evidence suggests that exercise has few adverse effects, with most reported issues being mild soreness or muscle pain that subsided after a few weeks, indicating that exercise can be a safe option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Geneen, LJ., Moore, RA., Clarke, C., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 systematic review of nine studies on educational interventions for chronic pain found that education alone does not significantly reduce pain or disability in adults, with pooled data showing no improvement compared to usual care.

The only positive outcome was observed with pain neurophysiology education (PNE), which showed a decrease in disability and improved knowledge about pain, but the evidence is not strong enough to recommend PNE as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. Geneen, LJ., Martin, DJ., Adams, N., et al.[2022]

In a 10-week program involving 41 participants with chronic pain, using Fitbits to track activity led to significant increases in step count, with 30% of participants increasing their steps by over 800, and improvements in anxiety and self-reported physical function associated with meeting individualized step goals.

The study suggests that combining Fitbit tracking with a mind-body activity program can effectively promote physical activity and improve emotional and physical function in individuals with chronic pain, highlighting the potential of wearable technology in managing chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. Grunberg, VA., Greenberg, J., Mace, RA., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 21 studies involving 37,143 participants found that physical activity and exercise can lead to small-to-moderate improvements in pain severity and physical function for adults with chronic pain, although results were inconsistent across different interventions.

The evidence quality was low due to small sample sizes and short follow-up periods, but the interventions were generally safe, with few adverse events reported, primarily mild soreness or muscle pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Geneen, LJ., Moore, RA., Clarke, C., et al.[2023]

In a 12-month study involving 229 participants with chronic back pain, those in a pedometer-based walking intervention reported a higher number of adverse events (350) compared to the usual care group (250), with musculoskeletal injuries being the most common.

Despite the increased reporting of musculoskeletal events, the study concludes that individuals with chronic back pain can safely participate in walking programs, suggesting the need for counseling on injury prevention and gradual increases in activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events experienced by participants in a back pain walking intervention: A descriptive study. Krein, SL., Abdul-Wahab, Y., Kadri, R., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10226285/

Fitbit activity, quota-based pacing, and physical and emotional ... Physical activity can improve function in patients with chronic pain, however, adherence is low, in part due to inconsistent activity patterns.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05700383?tab=results

The Thrive Study: Improving Multimodal Physical Function ... GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835320

Feasibility of a Mind-Body Program for Chronic Pain The mind-body walking program (GetActive-Fitbit) is a skills-based intervention. Its foundational skill is quota-based pacing, consisting of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424000363

Protocol for a multisite feasibility RCT GetActive-Fitbit is associated with sustained improvement in all aspects of physical function among sedentary adults with heterogenous chronic pain, as well as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6912090/

Development And Early Feasibility Testing Of A Mind-Body ... Participants in the GetActive with Fitbit group had a relatively high baseline step-count (>7300 steps, with most (5 out of 7) participants ...

6. escholarship.org escholarship.org/uc/item/7zf32325

A Mind-Body Physical Activity Program for Chronic Pain With or ... Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group ...