YOga for Patients With Chronic BACK Pain and Poor PROgnosis (YOBACK-PRO)
September 9, 2026 updated by: Rafael Zambelli Pinto, Federal University of Minas Gerais
Effectiveness of YOga in Patients With Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30130-110
- IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
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.
|
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.
|
|
Experimental: Yoga
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability
Time Frame: Post-intervention (i.e. 3 months after randomisation)
|
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
|
Post-intervention (i.e. 3 months after randomisation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability
Time Frame: 6 months after randomisation
|
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
|
6 months after randomisation
|
|
Pain intensity
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
|
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
|
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
|
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
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
|
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
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
|
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
|
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rafael Z Pinto, PhD, Federal University of Minas Gerais
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2023
Primary Completion (Actual)
December 22, 2025
Study Completion (Actual)
March 26, 2026
Study Registration Dates
First Submitted
July 12, 2023
First Submitted That Met QC Criteria
July 12, 2023
First Posted (Actual)
July 19, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2026
Last Update Submitted That Met QC Criteria
September 9, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 57028022.0.0000.5149
Plan for Individual participant data (IPD)
IPD Plan Description
The data of this study will be available from the principal investigator upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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