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Recruiting NCT05953155

YOga for Patients with Chronic BACK Pain and Poor PROgnosis

No phase Interventional Low Back Pain Chronic Low-back Pain Back Pain Back Pain Lower Back Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control, Yoga.
Who it may be relevant to
Registry conditions: Low Back Pain, Chronic Low-back Pain, Back Pain, Back Pain Lower Back Chronic. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Disability [Time frame: Post-intervention (i.e. 3 months after randomisation)]
Secondary outcome measures (5)
  • Disability [Time frame: 6 months after randomisation]
  • Pain intensity [Time frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
  • Quality of life [Time frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
  • Depressive symptoms [Time frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]
  • Pain self-efficacy [Time frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais — Belo Horizonte

Publications

  • 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. PMID 41605601

Identifiers

NCT: NCT05953155 · CAAE: 57028022.0.0000.5149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗