NCT05953155

YOga for Patients with Chronic BACK Pain and Poor PROgnosis

Effectiveness of YOga in Patients with Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the effectiveness of yoga for patients with chronic low back pain and high risk of poor prognosis. The main question it aims to answer is: \- In patients with back pain and high risk of poor prognosis, what is the effectiveness of yoga plus education on reducing pain and disability compared to a control group receiving education alone? A total of 110 patients with chronic low back pain and classified as high risk of poor prognosis according to the Orebro Musculoskeletal Pain Screening Questionnaire (i.e. score ≥ 50 points out of 100) will be recruited for this study. Participants will be randomized into two groups: yoga and control. The yoga group will receive a 3-month course of yoga program consisting of two sessions per week and 3 educational classes. The control group will receive 3 educational classes over a 12-week period. Outcome measures will be assessed at baseline, at post-intervention (i.e. 3-months post randomization) and at 6-month follow up (i.e. 6-months post randomization).

Conditions

• Low Back Pain
• Chronic Low-back Pain
• Back Pain
• Back Pain Lower Back Chronic

Interventions

Type	Name	Description
OTHER	Control	Each educational class will last for 1 hour and consists of evidence-based information about low back pain, including, for example, self-management strategies, pain education, reassurance and common misconceptions about back pain.
OTHER	Yoga	Participants in the intervention group will receive, in addition to the educational classes, a course of yoga program led by certified yoga instructors. The program consists of a 60-min group session with up to 10 participants, delivered twice a week for 12 weeks.

Timeline

• Start date: 2023-07-27
• Primary completion: 2026-07-31
• Completion: 2027-07-30
• First posted: 2023-07-19
• Last updated: 2025-03-17

Locations

1 site across 1 country: Brazil