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临床试验/CTRI/2024/07/070547
CTRI/2024/07/070547招募中2 期

Comparison Between Efficacy of Laser Therapy and Radial Shock Wave Therapy on Pain, Grip Strength and Function in Patient with Carpal Tunnel Syndrome: A Randomized Clinical Trial

Yadul Saikh1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年7月23日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
34
试验地点
1
主要终点
1.Pain intensity by VAS

研究概览

简要总结

PURPOSE OF THE STUDY

There are many studies available which showed the individual efficacy of LASER Therapy and Radial Shock Wave Therapy in Carpal Tunnel Syndrome. However, to the best of our knowledge, no such studies has been performed comparing between the efficacy of LASER Therapy and Radial Shock Wave Therapy in Carpal Tunnel Syndrome in Indian population.

Thus, the purpose of this study is to compare between efficacy of LASER Therapy and Radial Shock Wave Therapy on Pain, Grip strength and Function in Patients with Carpal Tunnel Syndrome.

AIM AND OBJECTIVES

AIM:

To compare between the efficacy of LASER Therapy and Radial Shock Wave Therapy on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.

OBJECTIVES**:**

1.     To find out the efficacy of LASER Therapy with standardized exercise on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.

2.     To find out the efficacy of Radial Shock Wave Therapy with standardized exercise on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome

3.     To compare between the efficacy of LASER Therapy and Radial Shock Wave Therapy on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.    HYPOTHESES

NULL HYPOTHESIS (H0)

There is no statistically significant difference between the efficacy of LASER Therapy and Radial Shock Therapy on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.

ALTERNATIVE HYPOTHESIS (H1)

There is statistically significant difference between the efficacy of LASER Therapy and Radial Shock Wave Therapy on Pain, Grip strength and Function in patient with Carpal Tunnel Syndrome.

PROCEDURE

Approval from the Institutional Ethical Committee (IEC) will be taken prior to the commencement of the study. All patients diagnosed with Carpal Tunnel Syndrome referred to the Department of Physiotherapy from the assessment clinic of National Institute for Locomotor Disabilities (Divyangjan) will be approached with the proposal of the study. They will be evaluated and screened according to inclusion and exclusion criteria. Patients meeting the exclusion criteria will not be included in the study. Those fulfilling the inclusion criteria will be explained in details about the study in their preferred language. Informed consent written in their preferred language will be obtained from the patients agreeing to participate. Then the patients will be randomly divided into two groups with a minimum of 17 patients in each group by block randomization method.

The demographic data and the baseline data for Pain intensity using VAS, Maximum Grip strength using Hand-Held Dynamometer and Functional status using Boston CTS Questionnaire will be collected from each patient before treatment. All the patients in “Group A” (n =17) will receive LASER Therapy 10 sessions (5 sessions per week for 2 weeks) along with Standardized Exercise Program and Home Exercise Program (5 sessions per week for 2 weeks), whereas patients in “Group B” (n=17) will receive Radial Shock Wave Therapy 4 sessions [in 2 weeks (on 1st, 4th, 7th and 10th day)] along with Standardized Exercise Program and Home Exercise Program (5 sessions per week for 2 weeks). The patients will be evaluated after 10th session of treatment and the data for Pain intensity, Grip Strength and Functional Status will be taken. Data will be analysed at the baseline and after 2 weeks.

Rescue medications duly prescribed by the physician will be continued along with the physiotherapeutic approach in both groups in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • 1.Both male and female patients.
  • 2.Age group between 30 to 60 years.
  • 3.Clinical symptoms, such as night pain, numbness, and tingling sensation on the median nerve distribution over the hand or both hand that have persisted for more than 1 months.
  • 4.VAS score between 3 cm to 7 cm.
  • 5.Any one of following special test should be positive; a.Phalens test b.Tinel sign c.Carpal compression test 6.Carpal Tunnel Syndrome confirmed by Nerve conduction velocity (NCV).

排除标准

  • 1.Musculoskeletal conditions like rheumatoid arthritis, upper limb fracture, hand deformity etc.
  • 2.Disorders that mimic CTS, such as cervical radiculopathy, polyneuropathy, and thoracic outlet syndrome etc.
  • 3.Metabolic disorders like acromegaly.
  • 4.History of corticosteroid injections in last 3 months or oral steroids in last 1months.
  • 5.Surgical history involving the wrist.
  • 6.Neurological conditions like Stroke, Complex regional pain syndrome (CRPS), Parkinson’s disease etc.
  • 7.Pregnancy.

结局指标

主要结局

1.Pain intensity by VAS

时间窗: 2 times -on day 0 and after 10 days of intervention

2.Maximum Grip strength by Hand-Held Dynamometer

时间窗: 2 times -on day 0 and after 10 days of intervention

3.Hand Function by BCTS Questionnaire

时间窗: 2 times -on day 0 and after 10 days of intervention

次要结局

未报告次要终点

研究者

发起方
Yadul Saikh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yadul Saikh

National Institute for Locomotor Disabilities(Divyangjan)

研究点 (1)

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