Effects of Antenatal Exercises With Sacroiliac Joint Mobilization in Pregnancy Related Pelvic Girdle Pain

September 13, 2022 updated by: Foundation University Islamabad
Pelvic girdle pain is the frequently occuring pregnancy-related musculoskeletal condition.It is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacroiliac joint.This condition is associated with difficulties in activities of daily life such as standing, walking, working and sleeping hence affecting the quality of life.Various management strategies including antenatal exercises, sacro iliac joint belt, kinesiotaping, sacro iliac joint mobilization etc are used for treating the pelvic girdle pain.Different studies have shown the positive results of antenatal exercises, sacro iliac joint belt and kinesiotaping on the pelvic girdle pain but there is lack of data available to establish the efficacy of sacro iliac joint mobilization on pregnancy-related pelvic girdle pain.So this study aims tofulfill this gap by comparing the effects of antenatal exercises with sacro iliac jpint mobilization on pelvic pain, function and disability in pregnancy-related pelvic girdle pain

Study Overview

Detailed Description

Pelvic girdle pain is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacro iliac joint.It is characterized by pain, instability, limitations in mobility and functioning of the pelvic region.This condition is found to be associated with difficulties in activities of daily life such as standing, walking, working and sleeping hence, affecting the quality of life.Pelvic girdle pain is on of the major preganacy-related problems that affects about 50% of the pregnant females.Previous studies have shown that about 33-50% of the women repost pelvic girdle pain before 20 weeks of gestation and the the prevalavce may reach 60-70% in late pregnancy.Different management strategies including antenatal exercises, sacro iliac joint belt, kinesiotaping, sacro iliac joint mobilization etc are used to treat pelvic girdle pain.Different studies have shown the positive results of antenatal exercises, sacro iliac joint belt and kinesiotaping but there is dearth of evidence to establish the efficacy of sacro iliac joint mobilization on pregnancy-related pelvic girdle pain.This study aims to fulfill this gap by comparing the effects of antenatal exercises with sacro iliac joint mobilization on pelvic pain, function and disability.

This randomized control trial will be conducted in Obs&Gynae Opd of Fauji Foundation Hospital using non-probability purposive sampling.Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw.Written informed consent will be taken from all the participants before conducting the research.Details of exercise program will be explained to them.Screening will be done by using PAR Q.Dignostic tests will be applied to confirm the pelvic girdle pain.FABERs test and Posterior Pelvic Pain Provocation test will be used for this purpose.Then the selected participants will be randomized into 2 groups(experimental group and control group)via lottery method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain, Pelvic Girdle Questionnaire for disability measurement and will perform Active Straight Leg raise test(ASLR) to measure pelvic function.All of these measurements will be taken at baseline, after 2 weeks and then after 4 weeks of intervention.

The treatment protocol of both groups is as follows:

Group 1(Control group):Postural education, hot pack, antenatal exercises(i.e deep breathing, stretching, kegel exercises, Mitchells physiologic relaxation technique and walk.

Group 2(Experimental group):Postural ecucation, hot pack, antenatal exercises(i.e deep breathing, stretching, kegel exercises, Mitchells physiologic relaxation technique and walk) and sacro iliac joint mobilization in side lying position(1 set of 30 oscillatios per session)

Study Type

Interventional

Enrollment (Anticipated)

32

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 Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Fauji Foundation 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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Both primiparous and multiparous gestational women of age 18-40 years
  • Gestational age: 13-24 weeks of 2nd trimester

Exclusion Criteria:

-History of: Miscarriages Early Neonatal Deaths Intra-uterine growth retardation Premature rupture of membranes Arthritis Twins/triplets pregnancies

  • Present complain of Pregnancy Induced Hypertension(HIP)
  • Placenta previa

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: Experimental group
Postural education Hot pack(10 min) Antenatal exercises(i.e. deep breathing(5 min), stretching(5 min), kegel exercises(5 min), Mitchells physiologic relaxation technique(10 min) and walk(10 min) Sacro iliac joint mobilization(5 min) Total duration:50 min/session
Sacroiliac joint mobilization will be performed with the patient in side lying position in which grade I,II pain relief mobilization will be given in PA direction.It will be given as 1 set of 30 oscillations per session, 3 times per week for 4 weeks.
Postural education, Hot pack, Antenatal exercises
Active Comparator: Control group
Postural education Hot pack(10 min) Antenatal exercises(i.e.deep breathing(5 min), stretching(5 min), kegel exercises(5 min), Mitchells physiologic relaxation technique(10 min) and walk(10 min) Total duration:45 min/session
Postural education, Hot pack, Antenatal exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 weeks
Pain intensity will be measured on numeric rating pain scale. It consists of 11 points( interval 0-10), where 0 corresponds to no pain and 10 corresponds to worst pain imaginable. A graphical representation of 11 spaces is used for patients own evaluation of his or her pain.
4 weeks
Disability
Time Frame: 4 weeks
The Pelvic Girdle Questionnaire(PGQ) is a condition-specific tool that assesses activity limitation and symptoms in patients with pelvic girdle pain .It consists of 20 activity items and 5 symptoms items scored on a 4-point response scale .Each question is scored from "Not at all" to "to a large extent". Items scores are summed and transformed to yield a score of 0 to 100, where 100 is the worst possible score
4 weeks
Pelvic function
Time Frame: 4 weeks
The Active Straight Leg Raise Test is a functional test used to assess pelvic girdle pain. It consists of a 6-point scale: not difficult at all=0, minimally difficult=1, somewhat difficult=2, fairly difficult=3, very difficult=4, unable to do=5. The scores of both sides are added so that the summed score can range from 0-10. Impairment is considered severe if the summed bilateral score is at least 4.
4 weeks

Collaborators and Investigators

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

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)

March 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • FUI/CTR/2022/16

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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