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临床试验/NCT03968796
NCT03968796已完成不适用

TENS and Kinesio Tape for Treatment Lateral Epicondylitis

European University of Lefke0 个研究点目标入组 78 人开始时间: 2013年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
主要终点
Pressure pain threshold

研究概览

简要总结

Lateral epicondylitis is the most common condition affecting the elbow and characterized by pain over the lateral epicondyle. The aim of this study was to determine and compare the efficacy of TENS and Kinesio Taping in lateral epicondylitis.

详细描述

In this prospective-randomized, assessor blinded controlled trial, seventy-eight patients (63 women, 15 men, mean age 47,5 ±7,94 years) with lateral epicondylitis were enrolled. Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS+sham Kinesio Taping, group 3 received sham TENS+ Kinesio Taping and group 4 received sham TENS+sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken.

Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 19 to 72
  • Enough cognitive ability to fill clinical assessment forms
  • Agreed to participate in the study

排除标准

  • Severe or progressive neurological deficits
  • Severe psychiatric disease history, substance and/or alcohol dependence,
  • Uncontrolled diabetes mellitus, malignancy, osteoporosis
  • A history of inflammatory or infectious disease
  • A skin allergy story
  • Previously undergone physical therapy due to lateral epicondylitis

研究组 & 干预措施

Group 1

Active Comparator

A total of 10 sessions of TENS were administered to each patient for 20 minutes daily.

Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment.

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Other)

Group 1

Active Comparator

A total of 10 sessions of TENS were administered to each patient for 20 minutes daily.

Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment.

干预措施: Kinesio Taping (Other)

Group 2

Active Comparator

A total of 10 sessions of TENS were administered to each patient for 20 minutes daily.

Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly.

干预措施: Sham Kinesio Taping (Other)

Group 2

Active Comparator

A total of 10 sessions of TENS were administered to each patient for 20 minutes daily.

Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly.

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Other)

Group 3

Active Comparator

A total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily.

Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment.

干预措施: Sham Transcutaneous Electrical Nerve Stimulation (TENS) (Other)

Group 3

Active Comparator

A total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily.

Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment.

干预措施: Kinesio Taping (Other)

Group 4

Placebo Comparator

A total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily.

Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly.

干预措施: Sham Transcutaneous Electrical Nerve Stimulation (TENS) (Other)

Group 4

Placebo Comparator

A total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily.

Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly.

干预措施: Sham Kinesio Taping (Other)

结局指标

主要结局

Pressure pain threshold

时间窗: 12 week

Pressure pain threshold was evaluated by algometer. The pressure pain threshold was measured at the lateral epicondyle with an algae before starting with a painless side in both extremities. Algometer is an instrument that measures the pain threshold and pain tolerance objectively. In the sitting position, the shoulder is evaluated at 30 ° abduction, and the elbow at 90 ° flexion over the lateral epicondyle (1 cm 2 area). In our study, the algometer was applied vertically to the most painful point by increasing the pressure by 1 kg / cm2 every 3 seconds until the patient felt pain. The pressure value that caused the pain feeling was determined as the pain threshold. In the 20-second intervals, the lowest pressure value was taken as the pain threshold between the three measurements. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

Patient-rated tennis elbow evaluation (PRTEE)

时间窗: 12 week

Patient-rated tennis elbow evaluation (PRTEE)was used to determine functional status. The PRTEE (Patient Based Inventory Evaluation Questionnaire) is a practical questionnaire that measures elbow pain and function and has been validated in lateral epicondylitis. It consists of a total of 15 questions about pain, function and daily activities. In our study, pain, function and total score were calculated for each patient. The pain score is obtained by summing the points given to the 5 questions related to the pain in the affected arm (minimum score 0, maximum score 50). Function score is obtained by dividing the scores of 10 questions evaluating the function in the affected arm and dividing by 2 (minimum score 0, maximum score 50). The total score is the sum of the pain score and function score (minimum score 0, maximum score of 100).Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

Pain-free grip strength

时间窗: 12 week

Hand grasping force with hand dynamometer was evaluated. The grip force was measured with the hand dynamometer as the maximum grip force, while the patient was sitting in the chair with 0 degrees of abduction and neutral position and the elbow with 90 degrees of flexion. Both sides were firstly measured on 2 sides and then averaged. 30 second rest periods were given between measurements.Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

Pain severity at rest, night and forced wrist extension test

时间窗: 12 week

Pain was evaluated with a 10 cm scale horizantal VAS. The head of the line was painless and the end was the most severe pain. The patient was asked to mark the most appropriate location for pain on the scale. Pain severity at rest, at night and forced wrist extension test was evaluated by visual analog scale (VAS). Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.

次要结局

未报告次要终点

研究者

发起方
European University of Lefke
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Telli

Assistant Professor - Medical Doctor

European University of Lefke

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