- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542888
Effects of Antenatal Exercises With Sacroiliac Joint Mobilization in Pregnancy Related Pelvic Girdle Pain
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Fauji Foundation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
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Postural education, Hot pack, Antenatal exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 4 weeks
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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.
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4 weeks
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Disability
Time Frame: 4 weeks
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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
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4 weeks
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Pelvic function
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2022/16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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