NCT05953155 YOga for Patients with Chronic BACK Pain and Poor PROgnosis
| NCT ID | NCT05953155 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Minas Gerais |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-07-27 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-07-27 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * report chronic nonspecific LBP, defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration. * score ≥ 50 points (out of 100) in the Orebro Musculoskeletal Pain Questionnaire. * have an average back pain intensity of 3 points or more on a 0-10 numerical pain rating scale. Exclusion Criteria: * serious spine pathology (e.g. tumors, fractures, and inflammatory diseases). * nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve). * previos spinal surgery. * pregnancy or having given birth within the previous 3 months. * any medical condition that prevented being physically active (e.g., serious cardiovascular, kidney or neurological diseases). * any other musculoskeletal condition that may affect activity and movement participation in a Yoga program during the last year. * not currently receiving other physical activity-based intervention (e.g., Pilates, physical therapy, aquatic exercise). * inadequate Portuguese literacy for the study's questionnaires and instructions.
Contact & Investigator
Rafael Z Pinto, PhD
PRINCIPAL INVESTIGATOR
Federal University of Minas Gerais
Frequently Asked Questions
Who can join the NCT05953155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05953155 currently recruiting?
Yes, NCT05953155 is actively recruiting participants. Contact the research team at rafaelzp@ufmg.br for enrollment information.
Where is the NCT05953155 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT05953155 clinical trial?
NCT05953155 is sponsored by Federal University of Minas Gerais. The principal investigator is Rafael Z Pinto, PhD at Federal University of Minas Gerais. The trial plans to enroll 110 participants.