search
Back to results

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

Primary Purpose

Sacroiliac Joint Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial release
pelvic Support belt
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaikh Zayed HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial release with support belt

Myofascial release without support belt:

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
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
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.
Pelvic girdle pain questionnaire (PGQ)
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 4, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05857839
Brief Title
Myofascial Release With and Without Support Belt for Sacroiliac Joint Pain in Pregnant Females.
Official Title
Effects of Myofascial Release With and Without Support Belt for Sacroiliac Joint Pain, Activity and Disability in Pregnant Females
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

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
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myofascial release with support belt
Arm Type
Experimental
Arm Description
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.
Arm Title
Myofascial release without support belt:
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
pelvic Support belt
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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
up to 4 weeks
Title
Quebec scale for functional disability
Description
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.
Time Frame
up to 4 weeks
Title
Pelvic girdle pain questionnaire (PGQ)
Description
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.
Time Frame
up to 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD*
Phone
051-5481826
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Shabbir, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaikh Zayed Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33984499
Citation
Chen Z, Wu J, Wang X, Wu J, Ren Z. The effects of myofascial release technique for patients with low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102737. doi: 10.1016/j.ctim.2021.102737. Epub 2021 May 10.
Results Reference
background
PubMed Identifier
19119403
Citation
Laslett M. Evidence-based diagnosis and treatment of the painful sacroiliac joint. J Man Manip Ther. 2008;16(3):142-52. doi: 10.1179/jmt.2008.16.3.142.
Results Reference
background
PubMed Identifier
33991702
Citation
Castro-Sanchez AM, Gil-Martinez E, Fernandez-Sanchez M, Lara-Palomo IC, Nastasia I, de Los Angeles Querol-Zaldivar M, Aguilar-Ferrandiz ME. Manipulative therapy of sacral torsion versus myofascial release in patients clinically diagnosed posterior pelvic pain: a consort compliant randomized controlled trial. Spine J. 2021 Nov;21(11):1890-1899. doi: 10.1016/j.spinee.2021.05.002. Epub 2021 May 13.
Results Reference
background
PubMed Identifier
16214275
Citation
Mens JM, Damen L, Snijders CJ, Stam HJ. The mechanical effect of a pelvic belt in patients with pregnancy-related pelvic pain. Clin Biomech (Bristol, Avon). 2006 Feb;21(2):122-7. doi: 10.1016/j.clinbiomech.2005.08.016. Epub 2005 Oct 7.
Results Reference
background
PubMed Identifier
28441294
Citation
Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
Results Reference
background
PubMed Identifier
33777508
Citation
Bhat P V, Patel VD, Eapen C, Shenoy M, Milanese S. Myofascial release versus Mulligan sustained natural apophyseal glides' immediate and short-term effects on pain, function, and mobility in non-specific low back pain. PeerJ. 2021 Mar 15;9:e10706. doi: 10.7717/peerj.10706. eCollection 2021.
Results Reference
background
PubMed Identifier
15778231
Citation
Elden H, Ladfors L, Olsen MF, Ostgaard HC, Hagberg H. Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial. BMJ. 2005 Apr 2;330(7494):761. doi: 10.1136/bmj.38397.507014.E0. Epub 2005 Mar 18.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs