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Effects of Pelvic Tilt Exercises With and Without Facet Joint Manipulation in Patients With Maigne's Syndrome

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Back Pain focused on measuring Maigne's syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients ages ranging between 20-40 years among male
  • Eligibility criteria include:
  • Tenderness on palpation test at thoracolumbar junction
  • Sensitivity difference on illiac crest
  • Positive skin rounding test
  • patients must have nonspecific unilateral pain in the lower lateral region of spine and radiates along the pelvis into the pubic region
  • Written informed voluntary consent

Exclusion Criteria:

  • Participants will be excluded if they had:
  • specific spinal pathology (e.g. disc lesions, malignancy, or inflammatory disease) or any other major medical pathology.
  • Patients having flattening in the lumbar lordosis according to the lumbar MRI results were excluded

Sites / Locations

  • General Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

19 patients will be treated with pelvic tilt exercises

19 patients will be treated with pelvic tilt exercises and facet joint manipulation.

Outcomes

Primary Outcome Measures

Numeric Pain rating Scale
To measure pain, Numeric Pain Rating Scale (NPRS) is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Modified Oswestry index
to measure disability, The Modified Oswestry disability index (MODI) has been developed to assess pain related disability. The questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage

Secondary Outcome Measures

Full Information

First Posted
September 13, 2021
Last Updated
April 21, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05052060
Brief Title
Effects of Pelvic Tilt Exercises With and Without Facet Joint Manipulation in Patients With Maigne's Syndrome
Official Title
Effects of Pelvic Tilt Exercises With and Without Facet Joint Manipulation in Patients With Maigne's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to find the effectiveness of exercise therapy and manipulative therapy for patients with maigne's syndrome. It is a Randomized clinical trial and convenient random sampling is to be used with an inclusion criteria of patients having maignes syndrome without having neurological signs and specific spinal pathology like disc lesion ,malignancy or inflammatory disease and any other major medical conditions .
Detailed Description
Maigne's syndrome is a pain disorder of low back which mainly affects the thoracolumbar junction of spine ,normally called as thoracolumber junction syndrome.It eludes healthcare professinals because of its pain presentation ,which is far away from the problematic site .Dr.Maigne wo was the founder of this syndrome stated that ,the most important cause behind this syndrome is Intervertebral dysfynction.It causes irritation ,inflammation and mild degeneration of involved intervertebral structures .Referred pain is the most important chracteristic of this syndrome which mainly involves lower back region ,groin ,lumbosacral region ,lower abdominl region and SI joint .Diagnostic criteria is based on 4 principles which need keen observation because many professionals simply fail to recognize it . To treat the Maigne's syndrome manipulation and exercise therapy is directed. In exercise therapy pelvic tilt exercises which include simple pelvic tilt ,addition of pelvic muscles ,addition of back extension with pelvic tilt and positioning of hands on back while performing exercise .and on the other hand in manipulative therapy facet joint manipulation included to reduce the pain , to increase pain free movement and to decrease other associated sign and symptoms. The aim of this study is to find the effectiveness of exercise therapy and manipulative therapy for patients with maigne's syndrome. It is a Randomized clinical trial and convenient random sampling is to be used with an inclusion criteria of patients having maignes syndrome without having neurological signs and specific spinal pathology like disc lesion ,malignancy or inflammatory disease and any other major medical conditions .patients also having lumbar flattening in lumbar lordosis according to MRI will be excluded.The main purpose of this randomized clinical trial will be to find out the effects of pelvic tilt exercises with and without facet joint manipulation in reducing pain and improvement in pain free sitting in patients with maigne's syndrome. Patients will be randomly allocated into two groups, Group A will receive exercise therapy intervention and Group B will receive manipulative therapy. Total duration of study will be three months with assessment will be done before treatment and after every 4 weeks. Numeric pain rating scale and oswestry index will be used to measure the outcomes. After collecting data from defined study setting, data will be entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows software, version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Maigne's syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
19 patients will be treated with pelvic tilt exercises
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
19 patients will be treated with pelvic tilt exercises and facet joint manipulation.
Intervention Type
Other
Intervention Name(s)
Group A
Intervention Description
19 patients will be treated with pelvic tilt exercises
Intervention Type
Other
Intervention Name(s)
Group B
Intervention Description
19 patients will be treated with pelvic tilt exercises and facet joint manipulation.
Primary Outcome Measure Information:
Title
Numeric Pain rating Scale
Description
To measure pain, Numeric Pain Rating Scale (NPRS) is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Time Frame
6 weeks
Title
Modified Oswestry index
Description
to measure disability, The Modified Oswestry disability index (MODI) has been developed to assess pain related disability. The questionnaire consists of 10 items addressing different aspects of function. Each item is scored from 0 to 5, with higher values representing greater disability. The total score is multiplied by 2 and expressed as a percentage
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ages ranging between 20-40 years among male Eligibility criteria include: Tenderness on palpation test at thoracolumbar junction Sensitivity difference on illiac crest Positive skin rounding test patients must have nonspecific unilateral pain in the lower lateral region of spine and radiates along the pelvis into the pubic region Written informed voluntary consent Exclusion Criteria: Participants will be excluded if they had: specific spinal pathology (e.g. disc lesions, malignancy, or inflammatory disease) or any other major medical pathology. Patients having flattening in the lumbar lordosis according to the lumbar MRI results were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23560215
Citation
Kim SR, Lee MJ, Lee SJ, Suh YS, Kim DH, Hong JH. Thoracolumbar Junction Syndrome Causing Pain around Posterior Iliac Crest: A Case Report. Korean J Fam Med. 2013 Mar;34(2):152-5. doi: 10.4082/kjfm.2013.34.2.152. Epub 2013 Mar 20.
Results Reference
background
Citation
Maigne R. Pain Syndromes of the Thoracolumbar Junction: A Frequent Source of Misdiagnosis. Physical Medicine and Rehabilitation Clinics Of North America. 1997;8(1):87-100.
Results Reference
background
Citation
Aktas I, Palamar D, Ozkan FU, Akgun K. Testicular pain due to thoracolumbar junction syndrome: a case report. Revista Internacional de Andrología. 2016;14(4):148-52.
Results Reference
background

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Effects of Pelvic Tilt Exercises With and Without Facet Joint Manipulation in Patients With Maigne's Syndrome

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