Chronic Low-back Pain (cLBP)NCT06910982
Yoga and Mindfulness for Chronic Low Back Pain: A Randomized Controlled Trial
A study testing Sphinx Pose Yoga Therapy in people with Chronic Low-back Pain (cLBP), run by University of Karachi at 1 site in Pakistan.
Trial summary
Chronic low back pain (CLBP) is a leading cause of disability, significantly impacting quality of life and work productivity. Traditional treatments often provide limited relief, necessitating alternative approaches. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Sphinx Pose Yoga Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders between 25 to 45 years of age.
- Subjects having low back pain complaints and have visited the healthcare provider in recent days.
- Numerical Pain Rating (NPR) scale score ≥ 2 for their pain intensity.
- Roland Morris Disability Questionnaire subject's score should be ≥ 4.
- Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score must be < 19.
Who cannot join
- Subjects with high risk for physical injuries during exercise.
- Pregnant and/or lactating females.
- Subjects with musculoskeletal disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Malir University of Science & Technology
Karachi, Sindh, 78500
About this study
Official title: Chronic Low Back Pain Management: Clinical and Psychophysiological Outcomes of Multimodal Approaches - A Randomized Controlled Trial on Yoga and Mindfulness.
Chronic low back pain (CLBP) is a leading cause of disability, significantly impacting quality of life and work productivity. Traditional treatments often provide limited relief, necessitating alternative approaches. This multicenter, parallel-arm, randomized controlled trial (RCT) aims to evaluate the efficacy of Sphinx Pose Yoga Therapy (Yoga), Mindfulness-Based Stress Reduction (MBSR), and their combination in managing CLBP among healthcare providers (HCPs).
Participants will be randomly assigned to one of four groups:
Read more
Group A (Yoga Therapy): Sphinx Pose Yoga therapy, practiced three times per week.
Group B (MBSR): Weekly mindfulness meditation, body scan, and gentle stretching.
Group C (Usual Care): Standard treatment guidelines as per The Back Book. Group D (Combined Yoga \& MBSR): Integrated approach, practiced twice per week. The study will assess pain intensity, functional disability, quality of life, physiological markers, mental health, and heart rate variability. Outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). The trial aims to determine whether Yoga, MBSR, or their combination provides superior benefits over usual care in CLBP management.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Sphinx Pose Yoga Therapy
- Keywords
- Chronic Low Back Pain, Yoga Therapy, Mindfulness-Based Stress Reduction, Sphinx Pose, Functional Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphinx Pose Yoga TherapyBehavioural
A structured yoga-based intervention focusing on the Sphinx Pose, aimed at improving spinal flexibility and reducing pain. Participants will perform three sessions per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sphinx Pose Yoga Therapy | Experimental | participants will undergo Sphinx Pose Yoga therapy involving gentle stretching exercises aimed at extending the back and activating muscles along the spine. Sessions will be conducted three times per week for 12 weeks. Receives: Behavioral: Sphinx Pose Yoga Therapy |
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Participants will engage in weekly MBSR sessions, which include mindfulness meditation, body scan exercises, gentle yoga movements, and stress reduction discussions. The intervention will last 12 weeks. Receives: Behavioral: Sphinx Pose Yoga Therapy |
| Usual Care | Active comparator | Participants will receive usual care as per "The Back Book," which includes standard guidelines for managing chronic low back pain (CLBP) without additional yoga or mindfulness interventions. Receives: Behavioral: Sphinx Pose Yoga Therapy |
| Combined Yoga and MBSR | Experimental | Participants will receive a combined intervention consisting of Sphinx Pose Yoga therapy and MBSR, integrating elements from both programs. Sessions will be held twice per week for 12 weeks. Receives: Behavioral: Sphinx Pose Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Measured using the Numerical Pain Rating (NPR) scale (0-10).
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Functional Disability
Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Physiological Markers
Cortisol (stress response). β-Endorphins (BE) (pain modulation). Substance-P (SP) (pain neurotransmitter). Interleukin-6 (IL-6) and C-reactive protein (CRP) (inflammation).
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Secondary outcomes (5)
Quality of Life (QoL)
Assessed using WHOQOL-BREF
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Stress Levels
Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale.
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Depression Symptoms
Evaluated via Beck Depression Inventory (BDI).
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Anxiety Levels
Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale.
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Heart Rate Variability (HRV)
Measured via wearable biofeedback device.
Measured: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
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 Chronic Low-back Pain (cLBP)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of four intervention groups: * Group A (Sphinx Pose Yoga therapy): Participants will undergo Sphinx Pose Yoga therapy, involving gentle stretching exercises aimed at extending the back and activating muscles along the spine, with sessions occurring thrice weekly. * Group B (MBSR): Participants will engage in Mindfulness-Based Stress Reduction (MBSR) sessions, combining mindfulness meditation and stretching to cultivate awareness and reduce stress. Sessions will include mindfulness meditation practices, body scan exercises, gentle yoga movements, and discussions on stress reduction and coping strategies, occurring weekly. * Group C (Usual Care): Participants will receive usual care as per The Back Book. * Group D (Combined Yoga and MBSR): Participants will receive a combined intervention of Sphinx Pose Yoga therapy and MBSR, incorporating elements from both programs, occurring twice weekly.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Education & Research Center
- Responsible party
- Principal investigator, Shamoon Noushad, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910982
- Sponsor's protocol ID
- CLBP-YM-RCT-2025
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Saleem Y, Noushad S, Ahmed S, Ansari B. Chronic low back pain management: clinical and psychophysiological outcomes of multimodal approaches-a randomised controlled trial on yoga and mindfulness. BMJ Open Sport Exerc Med. 2025 Jun 8;11(2):e002697. doi: 10.1136/bmjsem-2025-002697. eCollection 2025.
PubMed 40510459
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Low Back Pain Management: Clinical and Psychophysiological Outcomes of Multimodal Approaches - A Randomized Controlled Trial on Yoga and Mindfulness.
- ClinicalTrials.gov ID
- NCT06910982
- Acronym / sponsor ID
- CLBP-YM-RCT-2025
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Chronic Low Back Pain, Yoga Therapy, Mindfulness-Based Stress Reduction, Sphinx Pose, Functional Disability
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Advanced Education & Research Center
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Apr 2025 (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.
Chronic low back pain (CLBP) is a leading cause of disability, significantly impacting quality of life and work productivity. Traditional treatments often provide limited relief, necessitating alternative approaches. This multicenter, parallel-arm, randomized controlled trial (RCT) aims to evaluate the efficacy of Sphinx Pose Yoga Therapy (Yoga), Mindfulness-Based Stress Reduction (MBSR), and their combination in managing CLBP among healthcare providers (HCPs).
Participants will be randomly assigned to one of four groups:
Group A (Yoga Therapy): Sphinx Pose Yoga therapy, practiced three times per week.
Group B (MBSR): Weekly mindfulness meditation, body scan, and gentle stretching.
Group C (Usual Care): Standard treatment guidelines as per The Back Book. Group D (Combined Yoga \& MBSR): Integrated approach, practiced twice per week. The study will assess pain intensity, functional disability, quality of life, physiological markers, mental health, and heart rate variability. Outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). The trial aims to determine whether Yoga, MBSR, or their combination provides superior benefits over usual care in CLBP management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four intervention groups: * Group A (Sphinx Pose Yoga therapy): Participants will undergo Sphinx Pose Yoga therapy, involving gentle stretching exercises aimed at extending the back and activating muscles along the spine, with sessions occurring thrice weekly. * Group B (MBSR): Participants will engage in Mindfulness-Based Stress Reduction (MBSR) sessions, combining mindfulness meditation and stretching to cultivate awareness and reduce stress. Sessions will include mindfulness meditation practices, body scan exercises, gentle yoga movements, and discussions on stress reduction and coping strategies, occurring weekly. * Group C (Usual Care): Participants will receive usual care as per The Back Book. * Group D (Combined Yoga and MBSR): Participants will receive a combined intervention of Sphinx Pose Yoga therapy and MBSR, incorporating elements from both programs, occurring twice weekly.
| Arm | Type | Receives |
|---|---|---|
| Sphinx Pose Yoga Therapy | Experimental | Behavioral: Sphinx Pose Yoga Therapyparticipants will undergo Sphinx Pose Yoga therapy involving gentle stretching exercises aimed at extending the back and activating muscles along the spine. Sessions will be conducted three times per week for 12 weeks. |
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Behavioral: Sphinx Pose Yoga TherapyParticipants will engage in weekly MBSR sessions, which include mindfulness meditation, body scan exercises, gentle yoga movements, and stress reduction discussions. The intervention will last 12 weeks. |
| Usual Care | Active comparator | Behavioral: Sphinx Pose Yoga TherapyParticipants will receive usual care as per "The Back Book," which includes standard guidelines for managing chronic low back pain (CLBP) without additional yoga or mindfulness interventions. |
| Combined Yoga and MBSR | Experimental | Behavioral: Sphinx Pose Yoga TherapyParticipants will receive a combined intervention consisting of Sphinx Pose Yoga therapy and MBSR, integrating elements from both programs. Sessions will be held twice per week for 12 weeks. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders between 25 to 45 years of age.
- Subjects having low back pain complaints and have visited the healthcare provider in recent days.
- Numerical Pain Rating (NPR) scale score ≥ 2 for their pain intensity.
- Roland Morris Disability Questionnaire subject's score should be ≥ 4.
- Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score must be < 19.
Key exclusion criteria (3 listed)
- Subjects with high risk for physical injuries during exercise.
- Pregnant and/or lactating females.
- Subjects with musculoskeletal disorders.
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 |
|---|---|---|
| Sphinx Pose Yoga TherapyA structured yoga-based intervention focusing on the Sphinx Pose, aimed at improving spinal flexibility and reducing pain. Participants will perform three sessions per week for 12 weeks. | Behavioural | Combined Yoga and MBSR, Mindfulness-Based Stress Reduction (MBSR), Sphinx Pose Yoga Therapy, Usual Care |
Primary outcome
Pain Intensity
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Measured using the Numerical Pain Rating (NPR) scale (0-10).
Functional Disability
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).
Physiological Markers
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Cortisol (stress response). β-Endorphins (BE) (pain modulation). Substance-P (SP) (pain neurotransmitter). Interleukin-6 (IL-6) and C-reactive protein (CRP) (inflammation).
5 secondary outcomes
Quality of Life (QoL)
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Stress Levels
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Depression Symptoms
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Anxiety Levels
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Heart Rate Variability (HRV)
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 40510459Saleem Y, Noushad S, Ahmed S, Ansari B. Chronic low back pain management: clinical and psychophysiological outcomes of multimodal approaches-a randomised controlled trial on yoga and mindfulness. BMJ Open Sport Exerc Med. 2025 Jun 8;11(2):e002697. doi: 10.1136/bmjsem-2025-002697. eCollection 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphinx Pose Yoga Therapy in people with Chronic Low-back Pain (cLBP), run by University of Karachi at 1 site in Pakistan.
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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 4 Apr 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain Intensity (time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).). The study lists 3 primary outcomes in all. 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 NCT06910982, 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 4 Apr 2025.