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

NCT05857839 | Completed

• 1 other identifier: REC/RCR & AHS/23/0528
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Sacroiliac Joint Pain

Outcome Measures

Primary Outcomes (3)

• 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").

  up to 4 weeks

• 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.

  up to 4 weeks

• 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.

  up to 4 weeks

Study Arms (2)

Myofascial release with support belt

EXPERIMENTAL

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; Other: pelvic Support belt

Myofascial release without support belt:

ACTIVE COMPARATOR

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

Interventions

Myofascial release 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

Myofascial release with support belt; Myofascial release without support belt:

pelvic Support belt 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 with support belt

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-40 years.
• nd 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Shaikh Zayed Hospital

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 33984499 BACKGROUND

• 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.

  PMID: 19119403 BACKGROUND

• 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.

  PMID: 33991702 BACKGROUND

• 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.

  PMID: 16214275 BACKGROUND

• 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.

  PMID: 28441294 BACKGROUND

• 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.

  PMID: 33777508 BACKGROUND

• 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.

  PMID: 15778231 BACKGROUND

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Maria Shabbir, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 15, 2023
• Study Start: April 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)