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临床试验/CTRI/2025/11/096894
CTRI/2025/11/096894尚未招募不适用

Effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction- A Randomized Controlled Trial

Dr APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
1)Visual Analogue Scale (VAS)

研究概览

简要总结

PROJECT TITLE: EFFECT OF SELECTIVE TREATMENT PROTOCOL ON PAIN, MUSCLE STRENGTH, FUNCTIONAL DISABILITY AND QUALITY OF LIFE IN SACROILIAC JOINT DYSFUNCTION- A RANDOMIZED CONTROLLED TRIAL.

Dr. Anushka A Hashia1 Musculoskeletal Physiotherapy Resident, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India, Email- anushkahashia36@gmail.com

Dr. Neeraj Kumar2 Head of Department, Department of Orthopaedic Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India, Email- drneerajpt@gmail.com

AIMS AND OBJECTIVES

AIM:

The aim of this study is to determine the effect of selective treatment protocol on pain, muscle strength, functional disability & quality of life in sacroiliac joint dysfunction.

OBJECTIVES:

  1. To find out the effect of conventional treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.

  2. To find out the effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.

  3. To compare effects of conventional treatment protocol and selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.

SELECTION CRITERIA:

Inclusion criteria:

1)Age group 30 to 60 years.

2)Both male and female.

3)Unilateral sacroiliac joint dysfunction.

4)A pain score of equal to and more than 3/10 on visual analog scale (VAS) for sacroiliac pain in last 1.5 months.

5)Quadratus lumborum MMT 3

6)Pre diagnosed case

7)Using no other nonsteroidal anti-inflammatory drugs during the therapy.

8)Patients volunteered to participate in the study and signed informed consent

Exclusion criteria:

  1. Radiating pain.

2)Dislocation in lower back and lower extremity, fractures.

3)History of trauma.

4)Any systemic and metabolic disease.

5)Any rheumatologic disease.

6)Existence of known central nervous system or peripheral nervous system disease.

7)Pregnancy.

8)Involved in other treatments for pain relief.

METHODOLOGY:

Source of Data: Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni.

Study Setting: Department of Orthopedic Physiotherapy at Dr. APJAK College of Physiotherapy, PIMS, LONI.

Method of collection of data: Primary

Study Design:  Single blinded, Randomized Controlled Trial

Sample size: 74, Calculated by OpenEpi based on probability based random sampling method. After including 10% attrition rate the total sample size becomes 74+8= 82

Participants: Patients diagnosed with Sacroiliac Joint Dysfunction

Sampling Method: Simple Random Sampling

Study Duration: 2 years.

Material to be used:

  1. Data Record Sheet

2)Consent Form

Equipment:

1)Hot water fomentation (HWF)

2)Ultrasound

3)Therabands / weight cuff

4)Swiss ball

OUTCOME MEASURES

1)Visual Analogue Scale (VAS)

2)Modified Oswestry Disability Questionnaire

3)Short form 12 questionnaire (SF-12)

4)Manual Muscle Testing (MMT) of Quadratus Lumborum

PROCEDURE

After receiving ethical clearance by the Institutional Ethical Committee of Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS-DU. The Participants will be selected based on the inclusion and exclusion criteria for eligibility. Informed consent will be obtained from the participants, and demographic data is recorded. Participants will be randomly allocated to 2 groups that is experimental group (n=41) and the conventional group(n=41). Prior assessment of the participants will be done. Group A that is the experimental group will be receiving the selective treatment protocol and conventional treatment protocol and Group B will be receiving conventional treatment protocol alone for Sacroiliac Joint Dysfunction. An intervention study was designed to investigate the effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in Sacroiliac Joint Dysfunction.

Experimental Group- This treatment protocol is designed to treat patients with Sacroiliac Joint Dysfunction. It will be conducted 3 days a week on every alternate days for 6 weeks. Total duration of each treatment session will last for approximately 30 mins. All these sessions will be strictly performed and supervised by the researcher.

Conventional Group- These are conventional treatment to treat Sacroiliac Joint Dysfunction. It will be conducted 3 days a week on every alternate days for 6 weeks. Total duration of each treatment session will last for approximately 30 mins. All these sessions will be strictly performed and supervised by the researcher.

STUDY VARIABLES

Name of the variable

Measurement method

Statistical analysis

|Age

Interview

Nominal

|Gender

Observation

Nominal

|Pain

Visual Analogue Scale

Ordinal

|Strength

Manual Muscle Testing

Ratio

|Modified Oswestry Disability Questionnaire

Questionnaire

Ordinal

|Short form 12 Questionnaire

Questionnaire

Ordinal

STATISICAL ANALYSIS

Statistical Analysis will be done using appropriate test.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Unilateral sacroiliac joint dysfunction.
  • A pain score of equal to and more than 3/10 on visual analog scale (VAS) for sacroiliac pain in last 1.5 months.
  • Quadratus lumborum MMT 3 4)Pre diagnosed case 5)Using no other nonsteroidal anti-inflammatory drugs during the therapy.
  • Patients volunteered to participate in the study and signed informed consent.

排除标准

  • Radiating pain.
  • Dislocation in lower back and lower extremity, fractures.
  • History of trauma.
  • Any systemic and metabolic disease.
  • Any rheumatologic disease.
  • Existence of known central nervous system or peripheral nervous system disease.
  • Pregnancy.
  • Involved in other treatments for pain relief.

结局指标

主要结局

1)Visual Analogue Scale (VAS)

时间窗: All outcomes measured at baseline and after 6 weeks.

2)Modified Oswestry Disability Questionnaire

时间窗: All outcomes measured at baseline and after 6 weeks.

3)Short form 12 questionnaire (SF-12)

时间窗: All outcomes measured at baseline and after 6 weeks.

4)Manual Muscle Testing (MMT) of Quadratus Lumborum

时间窗: All outcomes measured at baseline and after 6 weeks.

次要结局

  • 1)Visual Analogue Scale (VAS)(2)Modified Oswestry Disability Questionnaire)

研究者

发起方
Dr APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

ANUSHKA A HASHIA

Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY

研究点 (1)

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