Syndrome, Manganese NeurotoxicityNCT07426900

Effects of Thoracolumbar Stabilization Versus Spinal Decompression Exercises on Maigne's Syndrome

A study testing Lumbothoracic stabilization exercises, Spinal decompression exercises and Standardized physical therapy treatment in people with Syndrome, Manganese Neurotoxicity, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study was conducted to compare the effect of thoracolumbar stabilization exercises versus spinal decompression exercises on pain, range of motion, disability and posture in patients with maigne's syndrome. Read more about this study

Who is it for?: Ages 20 to 45 years
Conditions the study is for: Syndrome, Manganese Neurotoxicity
What is being tested?: Lumbothoracic stabilization exercises, Spinal decompression exercises and Standardized physical therapy treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 sitePakistan
Study dates: 1 Jan 2025to 31 Oct 2025
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 20 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 20-45, Male/ Female NPRS > 4 Pain at T12-L1 and ipsilateral gluteal and/or groin pain. Local Tenderness on palpation at TLJ Sharp pain on palpation at posterior iliac crest • Positive KIBLER Skin fold Test on affected side. Allodynia or Hyperalgesia observed at sensory testing (pinprick and light touch) on ipsilateral side Negative Radiological Imaging for any bony deformity

Who cannot join

Any structural abnormalities like fractures/spondylosis History of any neurological or musculoskeletal problems History of cervical or thoracic surgery Psychological disorders. Cauda equina syndrome History of abdominal or groin pain Patients with positive FABER test, SLR test, Hip score test and SIJ compression test (30) Patients with positive Slump test, QL tightness, FAIR test

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Bahria nasheman medical center
Lahore, Punjab Province, 5400

Other trials in Pakistan

About this study

Official title: Comparative Effects of Thoracolumbar Stabilization Exercises Versus Spinal Decompression Exercises on Pain, Range of Motion, Disability and Posture in Patients With Maigne's Syndrome.

Conditions: Syndrome, Manganese Neurotoxicity
Being tested: Lumbothoracic stabilization exercises, Spinal decompression exercises, Standardized physical therapy treatment
Keywords: Decompression, Core stability, Lumbosacral plexus, Traction, Thoracic vertebrae, Lumbar vertebrae
Medical subject headings: Manganese Poisoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lumbothoracic stabilization exercisesOther
Each exercise session was performed for 30 minutes, with 3 sessions per week.
1. st Week, Isolated contraction of transverse abdominis and lumbar multifidus training was performed with 2 sets of 10 repetition, 10 second hold each time and rest period of 5 min.
2. nd week, co-contraction of transverse abdominis and multifidus in sitting and lying position was performed with 2 sets of 10 repetition, 10 second hold each time and rest period of 5 min.
3. rd week, co-contraction of transverse abdominis and multifidus in quadruped and standing position was performed with 2 sets of 10 repetition, 10 second hold each time and rest period of 5 min.
Spinal decompression exercisesOther
The exercise session was performed for 30 minutes, with 3 sessions per week In 1st week , patient performed pelvic tilt (lying), cat-cow stretch, thoracic extension on folded towel, child pose and plank . Each exercise was performed with 3 sets of 12 reps with 5-6 sec hold, with a rest of 30 sec In 2nd week, patient performed pelvic tilt (sitting) , cat cow stretch, thoracic extension on foam roller, child pose with side stretch and plank. . Each exercise was performed with 3 sets of 12 reps with 5-6 sec hold, with a rest of 30 sec.
In 3rd week, patient performed pelvic tilt ( standing ), cat cow stretch, thoracic extension on gym ball, child pose with passive stretch and side plank. . Each exercise was performed with 3 sets of 12 reps with 5-6 sec hold, with a rest of 30 sec.
Standardized physical therapy treatmentOther
Electric hot pack for 7 minutes. TENS 120 Hz at low intensity and 50-200μs pulse duration with electrodes placed in a crisscross pattern at T9 - L1 for 10 min Grade I \& II Maitland posteroanterior central (PAC) glide and unilateral posterior anterior glide (UPA) in 3 sets of 1 minute each with 1 minute interval at T9-L2

Study groups in NCT07426900
Study group	Role	What they receive
Thoracolumbar stabilization exercises	Experimental	Not described Receives: Other: Lumbothoracic stabilization exercises; Other: Standardized physical therapy treatment
Spinal decompression exercises	Active comparator	Not described Receives: Other: Spinal decompression exercises; Other: Standardized physical therapy treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Revised Oswestry Low Back Pain Disability Questionnaire
The Revised Oswestry Low Back Pain Disability Questionnaire (ODI) is a commonly used self-reported measure consisting of 10 sections that evaluate the impact of low back pain on everyday activities. It assesses areas such as pain severity, personal care, lifting, walking, sitting, standing, sleep, social activities, travel, and sexual function. The resulting score reflects the level of disability from minimal to severe and helps guide management of individuals with low back pain. In the current study it is used to measure the disability caused by thoracolumbar syndrome (Maigne's syndrome)
Measured: From enrollment to the end of 3 week treatment
Numeric pain rating scale
Numeric pain rating scale is used to evaluate pain. It consists of 11 points, having an overall score ranging from 0 and 10, where 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain and 7-10 represents severe pain.
Measured: From enrollment to the end of 3 week treatment

Secondary outcomes (4)

Thoracolumbar extension
Changes in thoracolumbar extension ROM at baseline and 3rd week of intervention were measured using bubble inclinometer
Measured: From enrollment to the end of 3 week treatment
Thoracolumbar rotation
Changes in thoracolumbar rotation ROM at baseline and 3rd week of intervention were measured using bubble inclinometer
Measured: From enrollment to the end of 3 week treatment
Thoracic Cobb's angle
Thoracic Cobb's angle at the baseline and 3rd week of intervention were measured using standing thoracolumbar x-ray
Measured: From enrollment to the end of 3 week treatment
Lumbar Cobb's angle
Lumbar Cobb's angle at the baseline and 3rd week of intervention were measured using standing thoracolumbar x-ray
Measured: From enrollment to the end of 3 week treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202531 Oct 2025

First posted23 Feb 2026
Study start1 Jan 2025
Primary completion31 May 2025
Study completion31 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Syndrome, Manganese NeurotoxicityStudies of the same condition, open and under way.
More trials run by Riphah International UniversityThe sponsor's other registered studies.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07426900
Sponsor's protocol ID: REC/RCR&AHS/24/0192
Status last verified: Feb 2026
First submitted: 17 Feb 2026
Last updated: 23 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

DiMond ME. Rehabilitative Principles in the Management of Thoracolumbar Syndrome: A Case Report. J Chiropr Med. 2017 Dec;16(4):331-339. doi: 10.1016/j.jcm.2017.10.003. Epub 2017 Dec 7.
PubMed 29276466
Fisher LR, Alvar BA, Maher SF, Cleland JA. Short-term Effects of Thoracic Spine Thrust Manipulation, Exercise, and Education in Individuals With Low Back Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2020 Jan;50(1):24-32. doi: 10.2519/jospt.2020.8928. Epub 2019 Dec 6.
PubMed 31810405
Maatman RC, Boelens OB, Scheltinga MRM, Roumen RMH. Chronic localized back pain due to entrapment of cutaneous branches of posterior rami of the thoracic nerves (POCNES): a case series on diagnosis and management. J Pain Res. 2019 Feb 19;12:715-723. doi: 10.2147/JPR.S178492. eCollection 2019.
PubMed 30863144
Gaowgzeh RAM, Chevidikunnan MF, BinMulayh EA, Khan F. Effect of spinal decompression therapy and core stabilization exercises in management of lumbar disc prolapse: A single blind randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(2):225-231. doi: 10.3233/BMR-171099.
PubMed 31282394
Segui Y, Ramirez-Moreno J. Global physiotherapy approach to thoracolumbar junction syndrome. A case report. J Bodyw Mov Ther. 2021 Jan;25:6-15. doi: 10.1016/j.jbmt.2020.10.003. Epub 2020 Oct 7.
PubMed 33714512
Singh T, Kumar PJBoFoPT. Pelvic pain in Maigne's syndrome-a multi-segmental approach. 2022;27(1):4.
Lee H, Chae H, Ryu M, Yang C, Kim S. Acupuncture for patients with Maigne's syndrome: A case series. Medicine (Baltimore). 2023 Jun 9;102(23):e33999. doi: 10.1097/MD.0000000000033999.
PubMed 37335654
Riaz V, Qamar S. Effects of Thoracic Extension versus Thoracic Stabilization Exercises on Pain, Stiffness, Range of Motion, Disability and Posture in patients with Maigne's Thoracic Pain
Alptekin K, Ornek NI, Aydin T, Alkan M, Toprak M, A Balci L, Oncu Alptekin J. Effectiveness of Exercise and Local Steroid Injections for the Thoracolumbar Junction Syndrome (The Maigne's Syndrome) Treatment. Open Orthop J. 2017 May 31;11:467-477. doi: 10.2174/1874325001711010467. eCollection 2017.
PubMed 28694884

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effects of Thoracolumbar Stabilization Exercises Versus Spinal Decompression Exercises on Pain, Range of Motion, Disability and Posture in Patients With Maigne's Syndrome.
ClinicalTrials.gov ID: NCT07426900
Acronym / sponsor ID: REC/RCR&AHS/24/0192
Conditions: Syndrome, Manganese Neurotoxicity
Keywords: Decompression, Core stability, Lumbosacral plexus, Traction, Thoracic vertebrae, Lumbar vertebrae
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 1 Jan 2025 (actual)
Primary completion: 31 May 2025 (actual)
Study completion: 31 Oct 2025 (actual)
First posted: 23 Feb 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Thoracolumbar stabilization exercises	Experimental	Other: Lumbothoracic stabilization exercises, Other: Standardized physical therapy treatment
Spinal decompression exercises	Active comparator	Other: Spinal decompression exercises, Other: Standardized physical therapy treatment

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Age 20-45, Male/ Female NPRS > 4 Pain at T12-L1 and ipsilateral gluteal and/or groin pain. Local Tenderness on palpation at TLJ Sharp pain on palpation at posterior iliac crest • Positive KIBLER Skin fold Test on affected side. Allodynia or Hyperalgesia observed at sensory testing (pinprick and light touch) on ipsilateral side Negative Radiological Imaging for any bony deformity

Key exclusion criteria (1 listed)

Any structural abnormalities like fractures/spondylosis History of any neurological or musculoskeletal problems History of cervical or thoracic surgery Psychological disorders. Cauda equina syndrome History of abdominal or groin pain Patients with positive FABER test, SLR test, Hip score test and SIJ compression test (30) Patients with positive Slump test, QL tightness, FAIR test

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
Lumbothoracic stabilization exercisesEach exercise session was performed for 30 minutes, with 3 sessions per week. 1. st Week, Isolated contraction of transverse abdominis and lumbar multifidus training was performed with 2 sets of 10 repetition, 10 second hold each time and rest period of 5 min. 2. nd week, co-contraction of transverse abdominis and multifidus in sitting and lying position was performed with 2 sets of 10 repetition, 10 second hold each time and rest period of 5 min. 3. rd week, co-contraction of transverse abdominis and multifidus in quadruped and standing position was performed with 2 sets of 10 repetition, 10 second hold each time and rest period of 5 min.	Other	Thoracolumbar stabilization exercises
Spinal decompression exercisesThe exercise session was performed for 30 minutes, with 3 sessions per week In 1st week , patient performed pelvic tilt (lying), cat-cow stretch, thoracic extension on folded towel, child pose and plank . Each exercise was performed with 3 sets of 12 reps with 5-6 sec hold, with a rest of 30 sec In 2nd week, patient performed pelvic tilt (sitting) , cat cow stretch, thoracic extension on foam roller, child pose with side stretch and plank. . Each exercise was performed with 3 sets of 12 reps with 5-6 sec hold, with a rest of 30 sec. In 3rd week, patient performed pelvic tilt ( standing ), cat cow stretch, thoracic extension on gym ball, child pose with passive stretch and side plank. . Each exercise was performed with 3 sets of 12 reps with 5-6 sec hold, with a rest of 30 sec.	Other	Spinal decompression exercises
Standardized physical therapy treatmentElectric hot pack for 7 minutes. TENS 120 Hz at low intensity and 50-200μs pulse duration with electrodes placed in a crisscross pattern at T9 - L1 for 10 min Grade I \& II Maitland posteroanterior central (PAC) glide and unilateral posterior anterior glide (UPA) in 3 sets of 1 minute each with 1 minute interval at T9-L2	Other	Spinal decompression exercises, Thoracolumbar stabilization exercises

Primary outcome

Revised Oswestry Low Back Pain Disability Questionnaire
Time frame: From enrollment to the end of 3 week treatment
The Revised Oswestry Low Back Pain Disability Questionnaire (ODI) is a commonly used self-reported measure consisting of 10 sections that evaluate the impact of low back pain on everyday activities. It assesses areas such as pain severity, personal care, lifting, walking, sitting, standing, sleep, social activities, travel, and sexual function. The resulting score reflects the level of disability from minimal to severe and helps guide management of individuals with low back pain. In the current study it is used to measure the disability caused by thoracolumbar syndrome (Maigne's syndrome)
Numeric pain rating scale
Time frame: From enrollment to the end of 3 week treatment
Numeric pain rating scale is used to evaluate pain. It consists of 11 points, having an overall score ranging from 0 and 10, where 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain and 7-10 represents severe pain.

4 secondary outcomes

Thoracolumbar extension
Time frame: From enrollment to the end of 3 week treatment
Thoracolumbar rotation
Time frame: From enrollment to the end of 3 week treatment
Thoracic Cobb's angle
Time frame: From enrollment to the end of 3 week treatment
Lumbar Cobb's angle
Time frame: From enrollment to the end of 3 week treatment

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 23 Feb 2026.
Background: PubMed 29276466DiMond ME. Rehabilitative Principles in the Management of Thoracolumbar Syndrome: A Case Report. J Chiropr Med. 2017 Dec;16(4):331-339. doi: 10.1016/j.jcm.2017.10.003. Epub 2017 Dec 7.
Background: PubMed 31810405Fisher LR, Alvar BA, Maher SF, Cleland JA. Short-term Effects of Thoracic Spine Thrust Manipulation, Exercise, and Education in Individuals With Low Back Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2020 Jan;50(1):24-32. doi: 10.2519/jospt.2020.8928. Epub 2019 Dec 6.
Background: PubMed 30863144Maatman RC, Boelens OB, Scheltinga MRM, Roumen RMH. Chronic localized back pain due to entrapment of cutaneous branches of posterior rami of the thoracic nerves (POCNES): a case series on diagnosis and management. J Pain Res. 2019 Feb 19;12:715-723. doi: 10.2147/JPR.S178492. eCollection 2019.
Background: PubMed 31282394Gaowgzeh RAM, Chevidikunnan MF, BinMulayh EA, Khan F. Effect of spinal decompression therapy and core stabilization exercises in management of lumbar disc prolapse: A single blind randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(2):225-231. doi: 10.3233/BMR-171099.
Background: PubMed 33714512Segui Y, Ramirez-Moreno J. Global physiotherapy approach to thoracolumbar junction syndrome. A case report. J Bodyw Mov Ther. 2021 Jan;25:6-15. doi: 10.1016/j.jbmt.2020.10.003. Epub 2020 Oct 7.
BackgroundSingh T, Kumar PJBoFoPT. Pelvic pain in Maigne's syndrome-a multi-segmental approach. 2022;27(1):4.
Background: PubMed 37335654Lee H, Chae H, Ryu M, Yang C, Kim S. Acupuncture for patients with Maigne's syndrome: A case series. Medicine (Baltimore). 2023 Jun 9;102(23):e33999. doi: 10.1097/MD.0000000000033999.
BackgroundRiaz V, Qamar S. Effects of Thoracic Extension versus Thoracic Stabilization Exercises on Pain, Stiffness, Range of Motion, Disability and Posture in patients with Maigne's Thoracic Pain
Background: PubMed 28694884Alptekin K, Ornek NI, Aydin T, Alkan M, Toprak M, A Balci L, Oncu Alptekin J. Effectiveness of Exercise and Local Steroid Injections for the Thoracolumbar Junction Syndrome (The Maigne's Syndrome) Treatment. Open Orthop J. 2017 May 31;11:467-477. doi: 10.2174/1874325001711010467. eCollection 2017.
Individual participant dataSharing planned: No

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.

Naila Kanwal principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 23 Feb 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?

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?

Revised Oswestry Low Back Pain Disability Questionnaire (time frame: From enrollment to the end of 3 week treatment). The study lists 2 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 NCT07426900, which also lists 9 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 23 Feb 2026.