204 Participants Needed

Physical Activity + Emotion Regulation for Lower Back Pain

(PATH Trial)

Recruiting at 1 trial location
AS
Overseen ByAngela Starkweather, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Connecticut
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 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.

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.12345

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.16789

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.310111213

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.

Research Team

CP

Crystal Park, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

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.
See 5 more

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.
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Physical activity + emotion regulation groupExperimental Treatment1 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 groupActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Back pain, physical function, and estimates of aerobic capacity: what are the relationships among methods and measures? [2019]
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]
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]
Physical activity in daily life in patients with chronic low back pain. [2022]
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]
Adverse events experienced by participants in a back pain walking intervention: A descriptive study. [2016]
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]
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]
The predictive relationship of physical activity on the incidence of low back pain in an occupational cohort. [2016]
Exercise programs for subjects with low back disorders. [2022]
Physical activity and low back pain: the role of subgroups based on the avoidance-endurance model. [2022]
Sustainability of a Motor Control Exercise Intervention: Analysis of Long-Term Effects in a Low Back Pain Study. [2021]
Psychosocial Moderators and Mediators of Sensorimotor Exercise in Low Back Pain: A Randomized Multicenter Controlled Trial. [2021]
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