Disc HerniationNCT07912047
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
A study testing SPINAL MOBILIZATION and SPINAL MOBILIZATION + CLINICAL PILATES in people with Disc Herniation, run by University of Management and Technology Lahore at 1 site in Pakistan.
Trial summary
Lumbar disc herniation is described by The North American Spine Society (NASS) as the confined movement of the disc material like nucleus pulposus and annulus fibrosis outside the limitations of the intervertebral disc space causing low back pain among adults. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Disc Herniation
- What is being tested?
- SPINAL MOBILIZATION and SPINAL MOBILIZATION + CLINICAL PILATES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2026to 31 Dec 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed patients with lumbar disc herniation. Both genders. Age ranging from 30 to 50 years. Unilateral radiating pain. low back pain for at least more than 3 weeks ranges from 4-6 on NPRS
Who cannot join
- Diagnosis of systemic metabolic and/or neurological disorder. Neuropathic pain due to damage of the nervous system Red flags conditions like infection, cauda equina syndrome and fractures Participants who had undergone surgery for LBP. Pregnancy
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
UMT
Lahore, Punjab Province, 54000
Muqadas Chaudary Dr. Muqadas Chaudary, TDPT, +923448466051, muqadas.chaudary@umt.edu.pk
Rabia Jawa COD, Mphil, +923434570838 ext. 6045, rabia.jawa@umt.edu.pk
About this study
Official title: EFFECTS OF SPINAL MOBILIZATION WITH AND WITHOUT CLINICAL PILATES ON PAIN, LUMBAR MOBILITY AND DISABILITY IN PATIENTS WITH LUMBAR DISC HERNIATION
Lumbar disc herniation is described by The North American Spine Society (NASS) as the confined movement of the disc material like nucleus pulposus and annulus fibrosis outside the limitations of the intervertebral disc space causing low back pain among adults. Low back pain become the most prevalent and common in adult generation. Lumbar disc herniation is the most common reason of low back pain in grown-ups of age saturation of 30 to 50 years. Lumbar disc herniation is affection almost 1 to 3% of the population per annum. There are many risk factors including alcohol, smoking, high intensity activities causing high load on your back or lifting high weight objects and genetic and environmental factors. The most affected and endorsed first line intervention protocol for lumbar disc herniation comprise of physical therapy management, life style adjustments and epidural steroid shots. This first line conservative management is used to avoid the risks of surgery and further complications. Spinal mobilization is used as the most effective and suggested option to help increase the mobility of the lumbar spine and reduce pain and disability chances in lumbar disc herniation patients. Clinical Pilates Exercise is used to upsurge core firmness and functional activity as well as boost the neuromuscular re-education in patients with disc herniation. The objective of this study is to compare the effects of spinal mobilization with or without Clinical Pilates on pain, lumbar mobility and disability in patients with lumbar disc herniation. Evaluation will be done by using NPRS, RODQ and Bubble Inclinometer. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation. Group A will receive spinal mobilization and Group B will receive spinal mobilization along with Pilates. Both groups will receive hot pack and TENS for 10 minutes as baseline treatment of herniated disc back pain before techniques application. Both groups will receive 12 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Results will be analyzed by using SPSS 24.
- Conditions
- Disc Herniation
- Being tested
- SPINAL MOBILIZATION, SPINAL MOBILIZATION + CLINICAL PILATES
- Keywords
- Lumbar disc herniation, Spinal Mobilization, Low Back Pain, Pilates, Range of Motion
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPINAL MOBILIZATIONOther
Group A will receive spinal mobilization along hot pack for 10 minutes and TENS for 10 minutes. In this group, participants will receive graded posteroanterior (PA) mobilizations on the affected lumbar segment L1-L5. The therapist will use oscillatory mobilizations of grade 1 and 2 within the pain free range depending on the patient's response and clinical evidences.
To apply spinal mobilization the members will be placed in an appropriate prone lying position on a couch and with hands on their respective sides. The therapist will place the hypothenar (ulnar) surface of the hand on the spinous process of the symptomatic lumbar vertebrae (L1-L5) while the other hand will be placed over the first hand to increase the force. Mobilization will be applied for 4 times with a 30-60 second of PA pressure and a resting interval of 20 sec. Apply 2 to 3 oscillations per sec. We'll start with the grade 1 and check the patient's response and gradually increase the grade of oscillations from 1 to 2
SPINAL MOBILIZATION + CLINICAL PILATESOther
For spinal mobilization, the participants will receive the same protocol just like the members of group A. However, the participants of this group will receive a session of Clinical Pilates Exercises. The exercises will be given to all the members of group B 3 days per week and the study continues for 4 weeks. The exercise session will be divided into 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HOT PACK+ TENS + SPINAL MOBILIZATION | Experimental | Group A will receive spinal mobilization along hot pack for 10 minutes and TENS for 10 minutes. In this group, participants will receive graded posteroanterior (PA) mobilizations on the affected lumbar segment L1-L5. The therapist will use oscillatory mobilizations of grade 1 and 2 within the pain free range depending on the patient's response and clinical evidences.
To apply spinal mobilization the members will be placed in an appropriate prone lying position on a couch and with hands on their respective sides. The therapist will place the hypothenar (ulnar) surface of the hand on the spinous process of the symptomatic lumbar vertebrae (L1-L5) while the other hand will be placed over the first hand to increase the force. Mobilization will be applied for 4 times with a 30-60 second of PA pressure and a resting interval of 20 sec. Apply 2 to 3 oscillations per sec. We'll start with the grade 1 and check the patient's response and gradually increase the grade of oscillations from 1 to 2 Receives: Other: SPINAL MOBILIZATION |
| HOT PACK+ TENS+ SPINAL MOBILIZATION + CLINICAL PILATES | Active comparator | For spinal mobilization, the participants will receive the same protocol just like the members of group A. However, the participants of this group will receive a session of Clinical Pilates Exercises. The exercises will be given to all the members of group B 3 days per week and the study continues for 4 weeks. The exercise session will be divided into 4 weeks Receives: Other: SPINAL MOBILIZATION + CLINICAL PILATES |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERIC PAIN RATING SCALE
Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in musculoskeletal pain. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs). It is evident that the NPRS are practical to use, yield accurate scores, and correspond to multi-item patient-reported outcome measures. More work is needed to improve the scales' responsiveness (meaningful change) and how change scores are interpreted. In neck pain research and management, the NPRS can be a helpful single-item evaluation to support more thorough multi-item patient-reported outcome measures
Measured: BASELINE AND 4 WEEKS
REVISED OSWESTERY DISABILITY INDEX
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 %. Bed-bound
Measured: BASELINE AND 4 WEEKS
BUBBLE INCLINOMETER
The spinous process of the 1st sacral vertebra and the 12th thoracic vertebra were considered as reference points for measuring the range of motion in bending forward and backward. The spinous process of the 12th thoracic vertebra was considered as reference point for measuring the range of motion of lumbar side flexion. Two bubble inclinometers were used simultaneously for measuring the lumbar range of motion when bending forward (in the standing position), and one bubble inclinometer for measuring the lumbar range of motion for back extension (in the standing) and side flexion (in the standing position). The actual ranges of motion of lumbar area when bending forward and backward were calculated by subtracting the number (degree) obtained by the lower inclinometer from the number (degree) obtained by the upper inclinometer
Measured: BASELINE AND 4 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start28 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationStudies 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
- Model description
- Lumbar disc herniation is described by The North American Spine Society (NASS) as the confined movement of the disc material like nucleus pulposus and annulus fibrosis outside the limitations of the intervertebral disc space causing low back pain among adults. Low back pain become the most prevalent and common in adult generation. Lumbar disc herniation is the most common reason of low back pain in grown-ups of age saturation of 30 to 50 years. Lumbar disc herniation is affection almost 1 to 3% of the population per annum. There are many risk factors including alcohol, smoking, high intensity activities causing high load on your back or lifting high weight objects and genetic and environmental factors. The most affected and endorsed first line intervention protocol for lumbar disc herniation comprise of physical therapy management, life style adjustments and epidural steroid shots. This first line conservative management is used to avoid the risks of surgery and further complications.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Management and Technology Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912047
- Sponsor's protocol ID
- RE-170-2026
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF SPINAL MOBILIZATION WITH AND WITHOUT CLINICAL PILATES ON PAIN, LUMBAR MOBILITY AND DISABILITY IN PATIENTS WITH LUMBAR DISC HERNIATION
- ClinicalTrials.gov ID
- NCT07912047
- Acronym / sponsor ID
- RE-170-2026
- Conditions
- Disc Herniation
- Keywords
- Lumbar disc herniation, Spinal Mobilization, Low Back Pain, Pilates, Range of Motion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Management and Technology LahoreUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Nov 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.
Lumbar disc herniation is described by The North American Spine Society (NASS) as the confined movement of the disc material like nucleus pulposus and annulus fibrosis outside the limitations of the intervertebral disc space causing low back pain among adults. Low back pain become the most prevalent and common in adult generation. Lumbar disc herniation is the most common reason of low back pain in grown-ups of age saturation of 30 to 50 years. Lumbar disc herniation is affection almost 1 to 3% of the population per annum. There are many risk factors including alcohol, smoking, high intensity activities causing high load on your back or lifting high weight objects and genetic and environmental factors. The most affected and endorsed first line intervention protocol for lumbar disc herniation comprise of physical therapy management, life style adjustments and epidural steroid shots. This first line conservative management is used to avoid the risks of surgery and further complications. Spinal mobilization is used as the most effective and suggested option to help increase the mobility of the lumbar spine and reduce pain and disability chances in lumbar disc herniation patients. Clinical Pilates Exercise is used to upsurge core firmness and functional activity as well as boost the neuromuscular re-education in patients with disc herniation. The objective of this study is to compare the effects of spinal mobilization with or without Clinical Pilates on pain, lumbar mobility and disability in patients with lumbar disc herniation. Evaluation will be done by using NPRS, RODQ and Bubble Inclinometer. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation. Group A will receive spinal mobilization and Group B will receive spinal mobilization along with Pilates. Both groups will receive hot pack and TENS for 10 minutes as baseline treatment of herniated disc back pain before techniques application. Both groups will receive 12 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Results will be analyzed by using SPSS 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Lumbar disc herniation is described by The North American Spine Society (NASS) as the confined movement of the disc material like nucleus pulposus and annulus fibrosis outside the limitations of the intervertebral disc space causing low back pain among adults. Low back pain become the most prevalent and common in adult generation. Lumbar disc herniation is the most common reason of low back pain in grown-ups of age saturation of 30 to 50 years. Lumbar disc herniation is affection almost 1 to 3% of the population per annum. There are many risk factors including alcohol, smoking, high intensity activities causing high load on your back or lifting high weight objects and genetic and environmental factors. The most affected and endorsed first line intervention protocol for lumbar disc herniation comprise of physical therapy management, life style adjustments and epidural steroid shots. This first line conservative management is used to avoid the risks of surgery and further complications.
| Arm | Type | Receives |
|---|---|---|
| HOT PACK+ TENS + SPINAL MOBILIZATION | Experimental | Other: SPINAL MOBILIZATIONGroup A will receive spinal mobilization along hot pack for 10 minutes and TENS for 10 minutes. In this group, participants will receive graded posteroanterior (PA) mobilizations on the affected lumbar segment L1-L5. The therapist will use oscillatory mobilizations of grade 1 and 2 within the pain free range depending on the patient's response and clinical evidences. To apply spinal mobilization the members will be placed in an appropriate prone lying position on a couch and with hands on their respective sides. The therapist will place the hypothenar (ulnar) surface of the hand on the spinous process of the symptomatic lumbar vertebrae (L1-L5) while the other hand will be placed over the first hand to increase the force. Mobilization will be applied for 4 times with a 30-60 second of PA pressure and a resting interval of 20 sec. Apply 2 to 3 oscillations per sec. We'll start with the grade 1 and check the patient's response and gradually increase the grade of oscillations from 1 to 2 |
| HOT PACK+ TENS+ SPINAL MOBILIZATION + CLINICAL PILATES | Active comparator | Other: SPINAL MOBILIZATION + CLINICAL PILATESFor spinal mobilization, the participants will receive the same protocol just like the members of group A. However, the participants of this group will receive a session of Clinical Pilates Exercises. The exercises will be given to all the members of group B 3 days per week and the study continues for 4 weeks. The exercise session will be divided into 4 weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically diagnosed patients with lumbar disc herniation. Both genders. Age ranging from 30 to 50 years. Unilateral radiating pain. low back pain for at least more than 3 weeks ranges from 4-6 on NPRS
Key exclusion criteria (1 listed)
- Diagnosis of systemic metabolic and/or neurological disorder. Neuropathic pain due to damage of the nervous system Red flags conditions like infection, cauda equina syndrome and fractures Participants who had undergone surgery for LBP. Pregnancy
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 |
|---|---|---|
| SPINAL MOBILIZATIONGroup A will receive spinal mobilization along hot pack for 10 minutes and TENS for 10 minutes. In this group, participants will receive graded posteroanterior (PA) mobilizations on the affected lumbar segment L1-L5. The therapist will use oscillatory mobilizations of grade 1 and 2 within the pain free range depending on the patient's response and clinical evidences. To apply spinal mobilization the members will be placed in an appropriate prone lying position on a couch and with hands on their respective sides. The therapist will place the hypothenar (ulnar) surface of the hand on the spinous process of the symptomatic lumbar vertebrae (L1-L5) while the other hand will be placed over the first hand to increase the force. Mobilization will be applied for 4 times with a 30-60 second of PA pressure and a resting interval of 20 sec. Apply 2 to 3 oscillations per sec. We'll start with the grade 1 and check the patient's response and gradually increase the grade of oscillations from 1 to 2 | Other | HOT PACK+ TENS + SPINAL MOBILIZATION |
| SPINAL MOBILIZATION + CLINICAL PILATESFor spinal mobilization, the participants will receive the same protocol just like the members of group A. However, the participants of this group will receive a session of Clinical Pilates Exercises. The exercises will be given to all the members of group B 3 days per week and the study continues for 4 weeks. The exercise session will be divided into 4 weeks. | Other | HOT PACK+ TENS+ SPINAL MOBILIZATION + CLINICAL PILATES |
Primary outcome
NUMERIC PAIN RATING SCALE
Time frame: BASELINE AND 4 WEEKS
Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in musculoskeletal pain. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs). It is evident that the NPRS are practical to use, yield accurate scores, and correspond to multi-item patient-reported outcome measures. More work is needed to improve the scales' responsiveness (meaningful change) and how change scores are interpreted. In neck pain research and management, the NPRS can be a helpful single-item evaluation to support more thorough multi-item patient-reported outcome measures
REVISED OSWESTERY DISABILITY INDEX
Time frame: BASELINE AND 4 WEEKS
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. This scale contain question related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. For patients understanding, URDU version is used. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 %. Bed-bound
BUBBLE INCLINOMETER
Time frame: BASELINE AND 4 WEEKS
The spinous process of the 1st sacral vertebra and the 12th thoracic vertebra were considered as reference points for measuring the range of motion in bending forward and backward. The spinous process of the 12th thoracic vertebra was considered as reference point for measuring the range of motion of lumbar side flexion. Two bubble inclinometers were used simultaneously for measuring the lumbar range of motion when bending forward (in the standing position), and one bubble inclinometer for measuring the lumbar range of motion for back extension (in the standing) and side flexion (in the standing position). The actual ranges of motion of lumbar area when bending forward and backward were calculated by subtracting the number (degree) obtained by the lower inclinometer from the number (degree) obtained by the upper inclinometer
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 3 Nov 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPINAL MOBILIZATION and SPINAL MOBILIZATION + CLINICAL PILATES in people with Disc Herniation, run by University of Management and Technology Lahore 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 1 inclusion and 1 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 3 Nov 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NUMERIC PAIN RATING SCALE (time frame: BASELINE AND 4 WEEKS). 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?
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 3 Nov 2026.