Physical Activity + Emotion Regulation for Lower Back Pain

(PATH Trial)

Recruiting at 1 trial location

Overseen By Angela Starkweather, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Back surgery, Sciatica, Chronic pain, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 30

Duration: 12 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will advance understanding on the mechanisms that mediate improved outcomes for chronic low back pain and provide specific directions for optimizing physical activity interventions for this population.

Will I have to stop taking my current medications?

The trial requires that you do not change your pain treatments during the study unless it's medically necessary, so you can continue taking your current medications as long as they remain the same.

Is the Physical Activity + Emotion Regulation treatment safe for humans?

A study on a walking intervention for back pain participants looked at the range and severity of adverse events, which suggests that safety data is being collected and monitored. However, specific safety outcomes or concerns are not detailed in the available research summaries. ^{1 2 3 4 5}

How does the physical activity and emotion regulation treatment for lower back pain differ from other treatments?

This treatment is unique because it combines physical activity with emotion regulation, addressing both the physical and emotional aspects of lower back pain. Unlike traditional exercise programs that focus solely on physical rehabilitation, this approach also targets emotional factors, which can influence pain perception and recovery. ^{6 7 8 9 10}

What data supports the effectiveness of this treatment for lower back pain?

Research shows that combining physical activity with education about pain can help reduce fear of movement and distress, leading to better outcomes like less disability and improved quality of life for people with chronic spinal pain, which may be similar to the benefits seen in lower back pain. ^{5 7 11 12 13}

Who Is on the Research Team?

Crystal Park, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic low back pain lasting more than half of the past six months. Participants must be willing to attend a 12-week yoga or stretching program, complete assessments, and not change their current pain treatments unless necessary. It's not for those with specific systemic causes of back pain, recent back surgery, certain muscle weakness, serious psychiatric or major medical conditions.

Inclusion Criteria

I agree to keep my pain treatment the same during the study unless a change is needed for my health.

I am willing to do yoga or stretching twice a week for 12 weeks.

I am older than 18 years.

Exclusion Criteria

I have not had back surgery in the past year.

I have a chronic pain condition like migraines or fibromyalgia.

I have a serious health condition like another cancer, severe lung disease, or extreme obesity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week physical activity intervention, with sessions twice a week and encouragement for daily home practice

12 weeks

24 visits (in-person), daily home practice

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 6 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity control intervention
• Physical activity + emotion regulation intervention

Trial Overview The study is testing two interventions: one combines physical activity with emotion regulation techniques; the other is a control intervention focusing on physical activity alone. The goal is to see which method better improves outcomes for people suffering from chronic low back pain.

How Is the Trial Designed?

Group I: Physical activity + emotion regulation group Experimental Treatment 1 Intervention

Participants randomized to the experimental group attend two group-based class sessions per week, each 1.25hours long, that are led by certified instructors who guide participants through various exercises. Participants are encouraged to practice the activities at home for 20 minutes each day.

Group II: Physical activity control group Active Control 1 Intervention

Participants randomized to the control group attend two group-based class sessions per week, each 1.25hours long, that are led by trained therapists who guide participants through a series of stretching exercises. Participants are encouraged to practice the activities at home for 20 minutes each day.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

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. United States pubmed.ncbi.nlm.nih.gov

Back pain, physical function, and estimates of aerobic capacity: what are the relationships among methods and measures? [2019]

2. England pubmed.ncbi.nlm.nih.gov

Promoting physical activity in low back pain patients: six months follow-up of a randomised controlled trial comparing a multicomponent intervention with a low intensity intervention. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Reductions in kinesiophobia and distress after pain neuroscience education and exercise lead to favourable outcomes: a secondary mediation analysis of a randomized controlled trial in primary care. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity in daily life in patients with chronic low back pain. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of incidental physical activity interventions compared to other interventions in the management of people with low back pain: A systematic review and meta-analysis of randomised controlled trials. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events experienced by participants in a back pain walking intervention: A descriptive study. [2016]

7. Japan pubmed.ncbi.nlm.nih.gov

Effects of Low-Dose Therapist-Led Self-Exercise Education on the Management of Chronic Low Back Pain: Protocol for a Community-Based, Randomized, 6-Month Parallel-Group Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

What Modifies the Effect of an Exercise Treatment for Chronic Low Back Pain? A Meta-epidemiologic Regression Analysis of Risk of Bias and Comparative Effectiveness. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The predictive relationship of physical activity on the incidence of low back pain in an occupational cohort. [2016]

10. Denmark pubmed.ncbi.nlm.nih.gov

Exercise programs for subjects with low back disorders. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity and low back pain: the role of subgroups based on the avoidance-endurance model. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Sustainability of a Motor Control Exercise Intervention: Analysis of Long-Term Effects in a Low Back Pain Study. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Psychosocial Moderators and Mediators of Sensorimotor Exercise in Low Back Pain: A Randomized Multicenter Controlled Trial. [2021]