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临床试验/NCT05542888
NCT05542888进行中(未招募)不适用

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

Foundation University Islamabad2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
32
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will be a another person who will be unaware of the group the particpant belong to.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Pain intensity

时间窗: 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.

Pelvic function

时间窗: 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.

Disability

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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