Physical Activity + Emotion Regulation for Lower Back Pain

(PATH Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how physical activity and emotion management can improve chronic low back pain. Participants will join either a group that combines exercise with emotion regulation techniques (physical activity + emotion regulation intervention) or a group that focuses on stretching exercises (physical activity control intervention). It suits individuals who have experienced low back pain for more than three of the last six months and are open to attending yoga or stretching classes twice a week for 12 weeks. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing chronic low back pain.

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

Research has shown that combining exercise with education about pain can reduce fear and worry in people with chronic low back pain. This combination can lead to less pain and improved treatment outcomes.

Previous studies have found that exercising regularly, about three times a week, improves back pain. These exercises are usually safe and well-tolerated, with few reports of serious side effects.

Additionally, learning to manage emotions, known as emotion regulation, has been shown to reduce pain in people with chronic pain. These methods are generally safe, with no significant negative effects reported.

Overall, both exercise and emotion management are considered safe and effective for improving chronic low back pain. Participants in these studies have generally handled the treatments well, with few or no serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Physical Activity + Emotion Regulation intervention for lower back pain because it uniquely combines physical exercise with emotional regulation techniques. Unlike standard treatments that often focus solely on physical therapy or medications, this approach addresses the psychological aspects of pain management, potentially leading to more comprehensive relief. By encouraging participants to engage in guided exercises and emotional coping strategies, this intervention aims to enhance overall well-being and provide a holistic way to manage lower back pain.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

This trial will compare two approaches for managing chronic low back pain: a physical activity control intervention and a physical activity combined with emotion regulation intervention. Research has shown that combining exercise with emotion management can reduce the fear of movement and distress in people with chronic low back pain. This approach has been linked to better outcomes, such as less pain and improved ability to perform daily activities. Studies also suggest that exercise can lower anxiety and depression, which benefits those with chronic pain. Additionally, evidence indicates that adding exercises to self-care strategies can moderately improve pain and disability. These findings suggest that using both exercise and emotion management might effectively manage chronic low back pain. ^{1 3 6 7 8}

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. withpower.com withpower.com/trial/phase-back-pain-9-2020-0d438

Physical Activity + Emotion Regulation 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10979342/

Testing Biological and Psychological Pathways of Emotion ... This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10970980/

Exploring the Links between Physical Activity, Emotional ... The students with high PA levels exhibited significantly lower levels of anxiety and depression compared to those with low or moderate PA levels ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468781221001533

Systematic review What is the effect of low back pain self ... There is low-quality evidence that SMIs with exercises added have moderately positive effects on pain and disability in patients with CLBP.

5. researchgate.net researchgate.net/publication/392540848_Emotion_regulation_interventions_on_physical_activity_a_systematic_review_and_meta-analysis

Emotion regulation interventions on physical activity Results may inform an efficacy study examining a new emotion-centric intervention for chronic pain. Dissemination will be through peer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162995/

Exercise prescription for improving chronic low back pain ... A frequency of three sessions per week [SMD = −1.44, 95% CI (−2.09, −0.78)] demonstrated significantly superior outcomes compared to the control ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526590024004814

Adverse Childhood Experiences and Chronic Low Back ... This study presents emotion dysregulation as a psychological pathway through which childhood adversity may contribute to cLBP in adulthood.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejp.2268

Emotion regulation skills‐focused interventions for chronic ... The findings provide evidence that ERSF interventions reduce pain intensity for people with chronic pain compared to usual treatment. These ...