Low Back PainYOBACK-PRONCT05953155
YOga for Patients With Chronic BACK Pain and Poor PROgnosis
A study testing Yoga in people with Low Back Pain and Chronic Low-back Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Chronic Low-back Pain, Back Pain
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jul 2023to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IPSEMG - Instituto de Previdência dos Servidores do Estado de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-110
About this study
Official title: 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).
- Being tested
- Control, Yoga
- Keywords
- low back pain, chronic low back pain, yoga, poor prognosis
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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.
YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Control |
| 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. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Measured: Post-intervention (i.e. 3 months after randomisation)
Secondary outcomes (5)
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
Measured: 6 months after randomisation
Pain intensity
Numerical Rating Scale for Pain assessment (NRS) (0-10 scale)
Measured: 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)
Measured: 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)
Measured: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Pain self-efficacy
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
Measured: Post-intervention (i.e. 3 months after randomisation) and at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start27 Jul 2023
- Primary completion22 Dec 2025
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Zambelli Pinto, Federal University of Minas Gerais
- Investigators
- Rafael Z Pinto, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953155
- Sponsor's protocol ID
- CAAE: 57028022.0.0000.5149
- Acronym
- YOBACK-PRO
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41605601
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of YOga in Patients With Chronic Low BACK Pain and Poor PROgnosis (YOBACK-PRO Trial): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05953155
- Acronym / sponsor ID
- YOBACK-PRO / CAAE: 57028022.0.0000.5149
- Keywords
- low back pain, chronic low back pain, yoga, poor prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlThe 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 | Other: YogaIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlEach 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 | Control |
| YogaParticipants 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. | Other | Yoga |
Primary outcome
Disability
Time frame: Post-intervention (i.e. 3 months after randomisation)
Roland Morris Disability Questionnaire (RMDQ) (0-24 scale)
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 41605601Nunes 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Z Pinto, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Low Back Pain and Chronic Low-back Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: Post-intervention (i.e. 3 months after randomisation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.