YOga for Patients with Chronic BACK Pain and Poor PROgnosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFederal University of Minas Gerais
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Control
Other interventionEach 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.
Yoga
Other interventionParticipants 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: YogaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Time frame
Post-intervention (i.e. 3 months after randomisation)Secondary outcomes
1
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Time frame
6 months after randomisation2
Pain intensity
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
Time frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up3
Quality of life
EuroQol Visual Analogue Scale (EQ-VAS) (0-100 scale)
Time frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up4
Depressive symptoms
Center for Epidemiological Studies - Depression (CES-D) (0-60 scale)
Time frame
Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov