Efficacy of High Voltage Pulsed Galvanic Stimulation on Pain, Grip strength and Function in Subjects with Chronic Lateral Epicondylitis: A Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1.Pain intensity by Numerical Pain Rating Scale
研究概览
简要总结
PURPOSE OF THE STUDY:
There are very few studies available in which High Voltage Pulsed Galvanic Stimulation shows the efficacy in combination with other technique on reducing pain, improving grip strength and function in subjects with chronic lateral epicondylitis. However, to the best of our knowledge there is no studies which shows the individual efficacy of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.
Therefore, the purpose of this study is to find out the efficacy of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.
AIM:
To find out the efficacy of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.
OBJECTIVES:
1 To find out the efficacy of High Voltage Pulsed Galvanic Stimulation along with Moist hot pack and Standardized exercise program on pain, grip strength and function in subjects with chronic lateral epicondylitis.
2 To find out the efficacy of Moist hot pack and Standardized exercise program on pain, grip strength and function in subjects with chronic lateral epicondylitis.
3 To compare the efficacy of High Voltage Pulsed Galvanic Stimulation along with Moist hot pack, Standardized exercise program and Moist hot pack, Standardized exercise program alone on pain, grip strength and function in subjects with chronic lateral epicondylitis.
HYPOTHESES
NULL HYPOTHESIS (H0):There is no statistically significant effect of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.
ALTERNATE HYPOTHESIS (H1):There is statistically significant effect of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.
PROCEDURE
Approval from the Institutional Ethical Committee (IEC) will be taken before commencement of the study. All subjects having elbow pain or diagnosed with lateral epicondylitis and referred to the department of Physiotherapy from the Assessment clinic (ASC) of NILD will be approached with the proposal of the study. Minimum of 34 subjects with lateral epicondylitis will be assessed and screened according to the inclusion and exclusion criteria. Subjects meeting the exclusion criteria will not be included. Those fulfilling the inclusion criteria will be explained in details about the study in their preferred language.Written Informed consent in their preferred language will be obtained from the subjects agreeing to participate. Then the demographic data will be collected. The subjects will be randomly divided into two groups by using Block randomization method by computer generated random blocks. All the subjects in Group-A (n=17) will be treated with High Voltage Pulsed Galvanic Stimulation, Moist hot pack, Standardized exercise program and Home Exercise Program (HEP) with Ergonomic care for 10 sessions (5sessions per week for 2weeks). All the subjects in Group- B (n=17) will be treated with Moist hot pack, Standardized exercise program and Home Exercise Program (HEP) with Ergonomic care for 10 sessions (5 sessions per week for 2 weeks). After completion of 10 sessions of intervention, all subjects will be adviced to continue HEP.
The data for Pain by Numerical Pain Rating Scale (NPRS), Pain-free Grip Strength by Hand-held Dynamometer (HHD) and Function by Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire will be taken at the pre intervention and post intervention i.e at the end of 10th sessions (5 sessions per week). Rescue medications duly prescribed by physician will be continued along with the physiotherapeutic approach in both the groups during 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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female subjects willing to participate in the study.
- •Subjects age group between 30 to 50 years.
- •NPRS score between 3 to
- •Subjects with chronic lateral epicondylitis more than 3 months.
- •Positive response on at least two of the following three provocative tests- Mills test, Cozens test, Maudsleys test.
排除标准
- •1.Musculoskeletal conditions like Osteoarthritis, Rheumatoid Arthritis, upper limb fracture, deformities, dislocations, myositis ossificans etc.
- •2.Infectious conditions around elbow like osteomyelitis, septic arthritis etc.
- •3.Any nerve entrapment syndrome of upper extremity like Pronator teres syndrome, carpal tunnel syndrome, radial tunnel syndrome etc.
- •4.Neurological conditions like cervical radiculopathy, stroke, reflex sympathetic dystrophy, Parkinson’s disease etc.
- •5.Recent history of local steroid injection within last three months, or oral steroid medication within last one month.
- •6.Any local skin disorder and impaired local skin sensation.
- •7.Red flag sign including a history of carcinoma, etc.
- •8.Non-co-operative and psychologically unstable subjects.
结局指标
主要结局
1.Pain intensity by Numerical Pain Rating Scale
时间窗: 2 times, on Day 0 and after 2 weeks
2.Grip Strength by Hand- held dynamometer
时间窗: 2 times, on Day 0 and after 2 weeks
3.Function by Patient Rated Tennis Elbow Evaluation
时间窗: 2 times, on Day 0 and after 2 weeks
次要结局
未报告次要终点
研究者
Jayashree Panda
National Institute For Locomotor Disabilities(Divyangjan)