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Clinical Trials/NCT05857839
NCT05857839
Completed
Not Applicable

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

Riphah International University1 site in 1 country30 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sacroiliac Joint Pain
Sponsor
Riphah International University
Enrollment
30
Locations
1
Primary Endpoint
Pelvic girdle pain questionnaire (PGQ)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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).

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
September 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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").

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.

Study Sites (1)

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