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

NCT ID: NCT05857839

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-09-15

Brief Summary

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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

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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.

Conditions

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Sacroiliac Joint Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Myofascial release

Intervention Type OTHER

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

pelvic Support belt

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Myofascial release

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Shabbir, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Shaikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 33984499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19119403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33991702 (View on PubMed)

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). 2006 Feb;21(2):122-7. doi: 10.1016/j.clinbiomech.2005.08.016. Epub 2005 Oct 7.

Reference Type BACKGROUND
PMID: 16214275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28441294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33777508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15778231 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0528

Identifier Type: -

Identifier Source: org_study_id

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