Myofascial Release With and Without Support Belt for Sacroiliac Joint Pain in Pregnant Females.

March 4, 2024 updated by: Riphah International University

Effects of Myofascial Release With and Without Support Belt for Sacroiliac Joint Pain, Activity and Disability in Pregnant Females

This study will be a randomized controlled trial that will include myofascial release interventions with and without a support belt. 34 Patients will be randomly divided into 2 groups. Assessment will be done by using Numeric Pain Rating Scale, Quebec scale for functional disability, and Pelvic girdle pain questionnaire (PGQ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sacroiliac joint dysfunction is a particularly common source of pain during pregnancy and is often an undiagnosed cause of low back pain. In this study, the effects of myofascial release with and without a support belt for sacroiliac joint pain and activity in pregnant females will be analyzed.

Group A of 17 patients will get a myofascial release technique for up to 600 seconds and total treatment sessions will be 12 in 4 weeks with a support belt a support belt should not be worn for longer than two to three hours at a time and it will be used 4 times a week. Group B of 17 patients will also get a myofascial release technique for up to 600 seconds and total treatment sessions will be 12 in 4 weeks but without a support belt. Data will be collected and analyzed at baseline and at 4 weeks follow-up.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Shaikh Zayed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 20-40 years.
  • 2nd and 3rd trimesters of pregnancy.
  • The diagnosis of SIJ pain based on tenderness localized to the posterior inferior iliac spine bilaterally with provocative maneuvers of the SIJ in posterior pelvic pain provocation/thigh thrust test, compression test, Gaenslen's test and Patrick's Faber test eliciting considerable pain.
  • Positive results from at least three of those provocative tests signified the presence of SIJ pain.

Exclusion Criteria:

  • History of rheumatic disease.
  • Lumbar spine disc herniation or back injury.
  • Previous lumbar spine surgery.
  • High risk pregnancy.
  • Any bony or soft tissue systemic disease.
  • Malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Myofascial release with support belt
Group A get myofascial release on sacroiliac joint area for up to 600 seconds and total treatment sessions will be 12 in 4 weeks with support belt and a support belt should not be worn for longer than two to three hours at a time and it will be used 4 times a week.
Other: Myofascial release
Patients will get myofascial release technique to sacroiliac joint area for up to 600 seconds and total treatment sessions will be 12 in 4 weeks
Other: pelvic Support belt
The support belt will be worn for less than two to three hours at a time and it will be used 4 times a week
Active Comparator: Myofascial release without support belt:
Group B get myofascial release technique to sacroiliac joint area for up to 600 seconds and total treatment sessions will be 12 in 4 weeks but without support belt. Data will be collected and analyzed at baseline and at 4 weeks follow up.
Other: Myofascial release
Patients will get myofascial release technique to sacroiliac joint area for up to 600 seconds and total treatment sessions will be 12 in 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: up to 4 weeks
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").
up to 4 weeks
Quebec scale for functional disability
Time Frame: up to 4 weeks
The degree of functional disability was estimated using the Quebec scale, assessing 20 routine daily activities on a scale from 0 to 5 (0 = performing activities without difficulty, 1 = performing activities with minimal difficulty, 2 = performing activities with some difficulty, 3 = performing activities with moderate difficulties, 4 = performing activities with greater difficulty, 5 = inability to perform activities). The minimum score was 20 and the maximum score was 100. Higher scores correlate with greater disability.
up to 4 weeks
Pelvic girdle pain questionnaire (PGQ)
Time Frame: up to 4 weeks
The Pelvic Girdle Questionnaire (PGQ) was also applied. It was created to assess quality of life in patients with pelvic girdle pain during pregnancy and postpartum. It includes 25 questions, with 20 questions aiming to assess activity and 5 questions examining symptoms. Each question is scored on a 4-point Likert type scale (from 'no problem at all' [0 points] to 'to a large extent' [3 points]). The raw scores are then converted into a final score ranging from 0 to 100 (from best to worst outcomes). The questionnaire's reliability and validity in Turkish have been confirmed.
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Maria Shabbir, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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