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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | The control group will be invited to attend 3 educational classes. In these sessions, participants will receive evidence-based information about self-management strategies and pain education. |
|
| Yoga | Experimental | In addition to the invitation to attend the same 3 educational classes on evidence-based information about self-management strategies and pain education, the experimental group will participate in a 12-week, twice-weekly group-based yoga program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Roland Morris Disability Questionnaire (RMDQ) (0-24 scale) | Post-intervention (i.e. 3 months after randomisation) |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Roland Morris Disability Questionnaire (RMDQ) (0-24 scale) | 6 months after randomisation |
| Pain intensity | Numerical Rating Scale for Pain assessment (NRS) (0-10 scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael Z Pinto, PhD | Contact | +55 31 3409 7405 | rafaelzp@ufmg.br | |
| Simone M Nunes, MSc | Contact | +55 31 32473137 | simacnunes@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Z Pinto, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais | Recruiting | Belo Horizonte | Minas Gerais | 30130-110 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41605601 | Derived | Nunes SM, Rizzo RR, Franco MR, Ferreira FR, Barros LJG, Maciel IT, Santos RL, Nascimento RR, Couto AJ, Quaresma LS, Fontes RM, Ferreira EMR, Maher CG, McAuley JH, Pinto RZ. Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial. BMJ Open. 2026 Jan 28;16(1):e112982. doi: 10.1136/bmjopen-2025-112982. |
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The data of this study will be available from the principal investigator upon reasonable request.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Yoga | Other | 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. |
|
| Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up |
| Quality of life | EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale) | Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up |
| Depressive symptoms | Center for Epidemiological Studies - Depression (CES-D) (0-60 scale) | Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up |
| Pain self-efficacy | Pain Self-Efficacy Questionnaire (PSEQ) (0-60) | Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |