YOga for Patients With Chronic BACK Pain and Poor PROgnosis

Study Overview
=================
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).

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

Conditions
-----------------
Low Back Pain, Chronic Low-back Pain, Back Pain, Back Pain Lower Back Chronic

Intervention / Treatment
-----------------
* Other: Control
* Other: Yoga


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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. | Other: Control<br>* 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.<br>|
| Experimental: Yoga<br>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. | Other: Yoga<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | 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 | Roland Morris Disability Questionnaire (RMDQ) (0-24 scale) | 6 months after randomisation | 
| Pain intensity | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, chronic low back pain, yoga, poor prognosis