- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426900
Effects of Thoracolumbar Stabilization Versus Spinal Decompression Exercises on Maigne's Syndrome
Comparative Effects of Thoracolumbar Stabilization Exercises Versus Spinal Decompression Exercises on Pain, Range of Motion, Disability and Posture in Patients With Maigne's Syndrome.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 5400
- Bahria nasheman medical center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Thoracolumbar stabilization exercises
|
Each exercise session was performed for 30 minutes, with 3 sessions per week.
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
|
|
Active Comparator: Spinal decompression exercises
|
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
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
From enrollment to the end of 3 week treatment
|
|
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.
|
From enrollment to the end of 3 week treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoracolumbar extension
Time Frame: From enrollment to the end of 3 week treatment
|
Changes in thoracolumbar extension ROM at baseline and 3rd week of intervention were measured using bubble inclinometer
|
From enrollment to the end of 3 week treatment
|
|
Thoracolumbar rotation
Time Frame: From enrollment to the end of 3 week treatment
|
Changes in thoracolumbar rotation ROM at baseline and 3rd week of intervention were measured using bubble inclinometer
|
From enrollment to the end of 3 week treatment
|
|
Thoracic Cobb's angle
Time Frame: From enrollment to the end of 3 week treatment
|
Thoracic Cobb's angle at the baseline and 3rd week of intervention were measured using standing thoracolumbar x-ray
|
From enrollment to the end of 3 week treatment
|
|
Lumbar Cobb's angle
Time Frame: From enrollment to the end of 3 week treatment
|
Lumbar Cobb's angle at the baseline and 3rd week of intervention were measured using standing thoracolumbar x-ray
|
From enrollment to the end of 3 week treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naila Kanwal, Riphah International University
Publications and helpful links
General Publications
- DiMond MEJJocm. Rehabilitative principles in the management of thoracolumbar syndrome: a case report. 2017;16(4):331-9.
- Fisher LR, Alvar BA, Maher SF, Cleland JAJJoo, therapy sp. Short-term effects of thoracic spine thrust manipulation, exercise, and education in individuals with low back pain: a randomized controlled trial. 2020;50(1):24-32.
- Maatman RC, Boelens OB, Scheltinga MR, Roumen RMJJoPR. 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. 2019:715-23
- Gaowgzeh RAM, Chevidikunnan MF, BinMulayh EA, Khan FJJob, rehabilitation m. Effect of spinal decompression therapy and core stabilization exercises in management of lumbar disc prolapse: A single blind randomized controlled trial. 2020;33(2):225-31.
- Ségui Y, Ramírez-Moreno JJJoB, Therapies M. Global physiotherapy approach to thoracolumbar junction syndrome. A case report. 2021;25:6-15.
- 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 SJM. Acupuncture for patients with Maigne's syndrome: A case series. 2023;102(23):e33999.
- 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, Örnek NI, Aydın T, Alkan M, Toprak M, Balcı LA, et al. Effectiveness of exercise and local steroid injections for the thoracolumbar junction syndrome (The Maigne's syndrome) treatment. 2017;11:467
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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