Chronic Non Specific Low Back PainNCT07738965
Mind-Body Pilates vs Pressure Biofeedback for Chronic Non-Specific Low Back Pain
A study testing Mind-Body Pilates and Pressure Biofeedback in people with Chronic Non Specific Low Back Pain and Pain, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
Chronic Non-Specific Low Back Pain means pain in the lower back that lasts for more than 3 months and does not have a serious cause like a fracture, infection, or nerve damage. It is very common and affects many people at some point in their lives. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Chronic Non Specific Low Back Pain, Pain, Core Strength
- What is being tested?
- Mind-Body Pilates and Pressure Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 30 Nov 2026
- 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 40-55 years.
- Diagnosed with chronic non-specific low back pain (pain lasting ≥12 weeks).
- Numeric Rating Scale (NRS) pain score ≥3.
- Able to understand study procedures and provide written informed consent.
- Able to participate in the exercise program and attend treatment sessions.
Who cannot join
- History of lumbar spine surgery within the past 12 months.
- Serious spinal pathology (fracture, tumor, infection, inflammatory disease).
- Neurological deficits or radiculopathy requiring surgical management.
- Pregnancy.
- Participation in a structured Pilates or core stabilization program within the previous 6 months.
- Any medical condition that prevents safe participation in exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Mind-Body Pilates Versus Pressure Biofeedback on Pain,Core Strength and Quality of Life in Chronic Non-Specific Low Back Pain
Chronic Non-Specific Low Back Pain means pain in the lower back that lasts for more than 3 months and does not have a serious cause like a fracture, infection, or nerve damage. It is very common and affects many people at some point in their lives.
This type of back pain usually happens because the muscles that support your spine become weak or do not work properly. It can also be linked to poor posture, sitting too long, lack of exercise, stress, or anxiety. Over time, this can lead to stiffness, reduced movement, and difficulty doing daily activities.
Read more
Treatment mainly focuses on exercise and staying active. Simple physiotherapy treatments like stretching, strengthening, and heat therapy can help reduce pain, but they may not fully improve the deeper muscles that support your back.
Two helpful exercise approaches are:
Mind-Body Pilates: This involves slow, controlled movements with proper breathing. It helps improve posture, strengthen core muscles, and reduce stress.
Pressure Biofeedback Training: This uses a small device to help you learn how to correctly activate deep abdominal muscles that support your spine.
Both methods can reduce pain and improve movement. Pilates focuses on whole-body control and relaxation, while biofeedback training focuses more on activating specific muscles.
In simple terms, regular exercise, good posture, and learning how to properly use your core muscles are key to managing long-term back pain and improving your quality of life.
- Being tested
- Mind-Body Pilates, Pressure Biofeedback
- Keywords
- Mind-Body Pilates, pressure biofeedback, chronic Non specific low back pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body PilatesBehavioural
A structured Mind-Body Pilates exercise program focusing on core stability, postural alignment, breathing control, and functional movement patterns. The program includes mat-based exercises targeting deep trunk muscles (transversus abdominis, multifidus) with emphasis on controlled movements and neuromuscular coordination. Sessions will be supervised by a physiotherapist, conducted 3 times per week for 6 weeks, with each session lasting approximately 45-60 minutes
Pressure BiofeedbackBehavioural
A core stabilization exercise program using a pressure biofeedback unit to facilitate activation and control of deep abdominal muscles, particularly the transversus abdominis. Exercises will be performed in progressive positions (supine, sitting, standing) with visual feedback to ensure correct muscle activation. Sessions will be supervised by a physiotherapist, conducted 3 times per week for 6 weeks, with each session lasting approximately 30-45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Pilates | Experimental | Participants in this group will receive a structured Mind-Body Pilates exercise program focusing on core stability, postural control, breathing, and functional movement. The program will be supervised by a physiotherapist and performed over a specified duration Receives: Behavioral: Mind-Body Pilates |
| Pressure Biofeed Back | Active comparator | Participants in this group will receive core stabilization exercises using pressure biofeedback to facilitate activation of deep trunk muscles. The intervention will be supervised by a physiotherapist and performed over a specified duration. Receives: Behavioral: Pressure Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). score range from 0 to 10, High score indicating greater pain
Measured: week 6
Secondary outcomes (1)
Pressure Biofeedback Unit
Core muscle strength will be assessed using the Pressure Biofeedback Unit (PBU) and measured in mmHg forPBU. Improvement is indicated by better activation and control of the deep trunk muscles during testing.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Non Specific 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mind-Body Pilates is a gentle exercise program designed to help reduce back pain and improve strength, posture, and movement. It focuses on slow, controlled movements combined with proper breathing and body awareness. In this program, patients perform specific exercises that target the deep muscles of the abdomen and back, which support the spine. These muscles are important for keeping the lower back stable and preventing pain from coming back. Each session usually includes: Breathing exercises to relax the body and improve control Core strengthening exercises to support the spine Stretching and flexibility exercises to reduce stiffness Posture training to improve body alignment Controlled movements to improve balance and coordination The exercises are done on a mat and are adjusted according to the patient's ability and comfort level. Movements are slow and precise, helping patients focus on how their body moves. Mind-Body Pilates not only improves physical strength but also hel
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore University of Biological and Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Shoaib Waqas, Principal investigator, drshoaibwaqas@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738965
- Sponsor's protocol ID
- UBAS/ERB/26/04/023
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu C, Fu Z, Wang X. Effect of Transversus abdominis muscle training on pressure-pain threshold in patients with chronic low Back pain. BMC Sports Sci Med Rehabil. 2021 Apr 1;13(1):35. doi: 10.1186/s13102-021-00262-8.
PubMed 33794983Khan M, et al. Inter-rater reliability of the Pressure Biofeedback Unit among clinicians measuring TrA activation. J Clin Physiother Res. 2022.
Gilliam JR, George SZ, Norman KS, Hendren S, Sahu PK, Silfies SP. Mind-Body Exercise Performed by Physical Therapists for Reducing Pain and Disability in Low Back Pain: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):776-789. doi: 10.1016/j.apmr.2022.10.004. Epub 2022 Dec 17.
PubMed 36535419Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.
PubMed 33781267
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mind-Body Pilates Versus Pressure Biofeedback on Pain,Core Strength and Quality of Life in Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07738965
- Acronym / sponsor ID
- UBAS/ERB/26/04/023
- Keywords
- Mind-Body Pilates, pressure biofeedback, chronic Non specific low back pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Jul 2026 (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 Non-Specific Low Back Pain means pain in the lower back that lasts for more than 3 months and does not have a serious cause like a fracture, infection, or nerve damage. It is very common and affects many people at some point in their lives.
This type of back pain usually happens because the muscles that support your spine become weak or do not work properly. It can also be linked to poor posture, sitting too long, lack of exercise, stress, or anxiety. Over time, this can lead to stiffness, reduced movement, and difficulty doing daily activities.
Treatment mainly focuses on exercise and staying active. Simple physiotherapy treatments like stretching, strengthening, and heat therapy can help reduce pain, but they may not fully improve the deeper muscles that support your back.
Two helpful exercise approaches are:
Mind-Body Pilates: This involves slow, controlled movements with proper breathing. It helps improve posture, strengthen core muscles, and reduce stress.
Pressure Biofeedback Training: This uses a small device to help you learn how to correctly activate deep abdominal muscles that support your spine.
Both methods can reduce pain and improve movement. Pilates focuses on whole-body control and relaxation, while biofeedback training focuses more on activating specific muscles.
In simple terms, regular exercise, good posture, and learning how to properly use your core muscles are key to managing long-term back pain and improving your quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Mind-Body Pilates is a gentle exercise program designed to help reduce back pain and improve strength, posture, and movement. It focuses on slow, controlled movements combined with proper breathing and body awareness. In this program, patients perform specific exercises that target the deep muscles of the abdomen and back, which support the spine. These muscles are important for keeping the lower back stable and preventing pain from coming back. Each session usually includes: Breathing exercises to relax the body and improve control Core strengthening exercises to support the spine Stretching and flexibility exercises to reduce stiffness Posture training to improve body alignment Controlled movements to improve balance and coordination The exercises are done on a mat and are adjusted according to the patient's ability and comfort level. Movements are slow and precise, helping patients focus on how their body moves. Mind-Body Pilates not only improves physical strength but also hel
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Pilates | Experimental | Behavioral: Mind-Body PilatesParticipants in this group will receive a structured Mind-Body Pilates exercise program focusing on core stability, postural control, breathing, and functional movement. The program will be supervised by a physiotherapist and performed over a specified duration |
| Pressure Biofeed Back | Active comparator | Behavioral: Pressure BiofeedbackParticipants in this group will receive core stabilization exercises using pressure biofeedback to facilitate activation of deep trunk muscles. The intervention will be supervised by a physiotherapist and performed over a specified duration. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 40-55 years.
- Diagnosed with chronic non-specific low back pain (pain lasting ≥12 weeks).
- Numeric Rating Scale (NRS) pain score ≥3.
- Able to understand study procedures and provide written informed consent.
- Able to participate in the exercise program and attend treatment sessions.
Key exclusion criteria (6 listed)
- History of lumbar spine surgery within the past 12 months.
- Serious spinal pathology (fracture, tumor, infection, inflammatory disease).
- Neurological deficits or radiculopathy requiring surgical management.
- Pregnancy.
- Participation in a structured Pilates or core stabilization program within the previous 6 months.
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 |
|---|---|---|
| Mind-Body PilatesA structured Mind-Body Pilates exercise program focusing on core stability, postural alignment, breathing control, and functional movement patterns. The program includes mat-based exercises targeting deep trunk muscles (transversus abdominis, multifidus) with emphasis on controlled movements and neuromuscular coordination. Sessions will be supervised by a physiotherapist, conducted 3 times per week for 6 weeks, with each session lasting approximately 45-60 minutes | Behavioural | Mind-Body Pilates |
| Pressure BiofeedbackA core stabilization exercise program using a pressure biofeedback unit to facilitate activation and control of deep abdominal muscles, particularly the transversus abdominis. Exercises will be performed in progressive positions (supine, sitting, standing) with visual feedback to ensure correct muscle activation. Sessions will be supervised by a physiotherapist, conducted 3 times per week for 6 weeks, with each session lasting approximately 30-45 minutes | Behavioural | Pressure Biofeed Back |
Primary outcome
Numeric Pain Rating Scale
Time frame: week 6
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). score range from 0 to 10, High score indicating greater pain
1 secondary outcome
Pressure Biofeedback Unit
Time frame: week 6
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 31 Jul 2026.
- Background: PubMed 33794983Xu C, Fu Z, Wang X. Effect of Transversus abdominis muscle training on pressure-pain threshold in patients with chronic low Back pain. BMC Sports Sci Med Rehabil. 2021 Apr 1;13(1):35. doi: 10.1186/s13102-021-00262-8.
- BackgroundKhan M, et al. Inter-rater reliability of the Pressure Biofeedback Unit among clinicians measuring TrA activation. J Clin Physiother Res. 2022.
- Background: PubMed 36535419Gilliam JR, George SZ, Norman KS, Hendren S, Sahu PK, Silfies SP. Mind-Body Exercise Performed by Physical Therapists for Reducing Pain and Disability in Low Back Pain: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):776-789. doi: 10.1016/j.apmr.2022.10.004. Epub 2022 Dec 17.
- Background: PubMed 33781267Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.
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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.
Prof. Dr. Shoaib Waqas principal investigator
drshoaibwaqas@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Pilates and Pressure Biofeedback in people with Chronic Non Specific Low Back Pain and Pain, run by Lahore University of Biological and Applied Sciences 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 6 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: opening soon, as of the sponsor's last update on 31 Jul 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 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?
Contact Muhammad Muzamil Arif, Masters of Physical Therapy (+92 3204308705, muzamilarif420@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: week 6). 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 NCT07738965, which also lists 4 linked publications.
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 31 Jul 2026.