NCT05052060

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

September 13, 2021

Last Update Submit

April 21, 2022

Conditions

Back Pain

Keywords

Maigne's syndrome

Outcome Measures

Primary Outcomes (2)

  • 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")

    6 weeks

  • 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

    6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

19 patients will be treated with pelvic tilt exercises

Other: Group A

Group B

ACTIVE COMPARATOR

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

Other: Group B

Interventions

Group AOTHER

19 patients will be treated with pelvic tilt exercises

Group A
Group BOTHER

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

Group B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 23560215BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 22, 2021

Study Start

October 15, 2021

Primary Completion

February 28, 2022

Study Completion

March 20, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)