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临床试验/CTRI/2025/10/095581
CTRI/2025/10/095581尚未招募不适用

Comparative effectiveness of muscle energy technique and positional release technique on hip pain, range of motion and function in piriformis syndrome

NA1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年10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
NA
入组人数
22
试验地点
1
主要终点
VAS for hip pain

研究概览

简要总结

Introduction

Piriformis syndrome is a painful musculoskeletal condition characterized by buttock or hip pain, often leading to chronic discomfort, restricted hip mobility, and functional limitations.

It can significantly affect daily activities and impose a socioeconomic burden. Manual therapy techniques such as Muscle Energy Technique (MET) and Positional Release Technique (PRT) are frequently used in its management. MET aims to improve muscle length and joint mobility through controlled contractions, whereas PRT reduces muscle spasm by positioning the muscle in a shortened, pain-free state.

Review of Literature-Previous studies have demonstrated positive effects of both techniques on pain, hip range of motion (ROM), and function in piriformis syndrome; however, there is no consensus on which is more effective. Limited comparative research exists, creating a gap in evidence-based practice.

This study aims to compare the effectiveness of MET and PRT on pain, hip internal rotation ROM, and functional ability in individuals with piriformis syndrome.

Objectives and Hypothesis

• Primary Objectives:

To compare the effectiveness of Muscle Energy Technique (MET) and Positional Release Technique (PRT) on pain, hip internal rotation and function in piriformis syndrome.

• Null hypothesis: There is no significant difference in the effectiveness of MET and PRT on pain (VAS), improving hip internal rotation (Universal Goniometer) and in enhancing function (LEFS) in individuals with piriformis syndrome.

• Alternate hypothesis: There is significant difference in the effectiveness of MET and PRT on pain (VAS), improving hip internal rotation (Universal Goniometer) and function in piriformis syndrome.

Materials and Methods

a. Study Design: Randomized Controlled Trial

b. Sample size and method

Sample Size: 22 participants (11 in each group)

Method of Calculation: Based on previous study (Velappanchavadi, 2019) taking VAS (Visual Analog Scale) as the primary outcome, with:

Effect size = 1.11

Alpha = 0.05

Power = 0.80

c. Enrolment period: approximately 5–6 months after RRC and IEC approval

d. Total Study duration: approximately 6 months

e. Inclusion and exclusion criteria:  Participants aged 18–50 years diagnosed with piriformis syndrome with unilateral buttock pain more than or equal to 4 cm on VAS for at least 1 month will be included. Exclusion criteria include spinal pathologies, prior spine/lower limb surgery, neurological disorders, pregnancy, and positive SLR.

f. Study Procedure: After RRC and IEC clearance, participants fulfilling inclusion criteria were enrolled after informed consent. They were randomly allocated into two groups using random allocation software. Baseline assessment of pain (VAS), hip internal rotation (Universal Goniometer), and function (LEFS) was done.

Group A: MET and  Conventional Physiotherapy

Group B: PRT and  Conventional Physiotherapy

Both groups received 6 sessions per week for 2 weeks. Post-intervention assessments were taken at the end of week 1 and week 2 using the same outcome measures. Data collection lasted 5–6 months and analysis will be  performed using SPSS v21.

g. Assessment tools:

Pain is assesses by Visual Analog Scale (VAS)

Hip Internal Rotation Range of Motion assess by  Universal Goniometer

Function assesses by  Lower Extremity Functional Scale (LEFS)

Statistical Analysis Plan (SAP)

Data will be analyzed using SPSS v21.0 with a significance level of  0.05 and power of 0.80 . Descriptive statistics will summarize data as mean and standard deviation or median (IQR) for continuous variables and frequencies for categorical variables. Normality will be tested using the Shapiro–Wilk test. For normal data, between-group changes will be analyzed using Mixed-Model ANOVA and within-group changes using Repeated Measures ANOVA; for non-normal data, the Friedman and Wilcoxon signed-rank tests will be used. Effect sizes, p-values, and 95 percentage confidence intervals will be reported, with missing data handled appropriately.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Unilateral buttock pain Pain greater or equal to 4cm or above on VAS and persists for at least 1 month Aggravation of pain by sitting External tenderness over the greater sciatic notch Pain with maneuvers that increase tension in the piriformis muscle.
  • FAIR Flexion, Adduction and Internal rotation HCLK Heel contralateral knee participants diagnosed with piriformis syndrome.

排除标准

  • Diagnosed with spinal causes of sciatic pain: Lumbar disc herniation, spinal stenosis, spondylolisthesis History of spine or lower limb surgery Diagnosed with neurological disorders- peripheral neuropathy Axial Spinal palpation painful L2 to S1 SLR Positive Pregnancy.

结局指标

主要结局

VAS for hip pain

时间窗: 0 week (Baseline), 1 week and 2 weeks

次要结局

  • Universal goniometer for hip range of motion and LEFS for function

研究者

发起方
NA
申办方类型
Other [n/a]
责任方
Principal Investigator
主要研究者

Mehar Negi

ISIC -IRS

研究点 (1)

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