Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis

Not Applicable

Completed

• Conditions: Lateral Epicondylitis (Tennis Elbow) Bilateral; Tenosynovitis Elbow; Pain in Arm, Unspecified
• Interventions: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS); Other: Kinesio Taping; Other: Sham Kinesio Taping

• Registration Number: NCT03968796
• Lead Sponsor: European University of Lefke

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2013-08-31
• Study Completion: 2013-08-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Kinesio Taping	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.
Group 2	Transcutaneous Electrical Nerve Stimulation (TENS)	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.
Group 3	Kinesio Taping	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.
Group 3	Sham Transcutaneous Electrical Nerve Stimulation (TENS)	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.
Group 1	Transcutaneous Electrical Nerve Stimulation (TENS)	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.
Group 2	Sham Kinesio Taping	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.
Group 4	Sham Transcutaneous Electrical Nerve Stimulation (TENS)	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.
Group 4	Sham Kinesio Taping	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.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	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)	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	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	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.