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

TENS and Kinesio Tape for Treatment Lateral Epicondylitis

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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.	Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Kinesio Taping
Active Comparator: Group 2; 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.	Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Sham Kinesio Taping
Active Comparator: Group 3; 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.	Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS); Other: Kinesio Taping
Placebo Comparator: Group 4; 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.	Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS); Other: Sham Kinesio Taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-free grip strength	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.	12 week
Pain severity at rest, night and forced wrist extension test	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.	12 week
Pressure pain threshold	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.	12 week
Patient-rated tennis elbow evaluation (PRTEE)	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.	12 week

Collaborators and Investigators

• Sponsor: European University of Lefke
• Investigators: Principal Investigator: Hilal Telli, MD, European University of Lefke

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): August 31, 2013
• Study Completion (Actual): August 31, 2013

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: TENS; Lateral epicondylitis; Kinesio Taping; Tennis elbow
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow; Tenosynovitis
• Other Study ID Numbers: Lateral epicondylitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No