Effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction- A Randomized Controlled Trial
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:
-
To find out the effect of conventional treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.
-
To find out the effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.
-
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:
- 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:
- 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
ANUSHKA A HASHIA
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY
