Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis
TENS and Kinesio Tape for Treatment Lateral Epicondylitis
1 other identifier
interventional
78
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2013
CompletedFirst Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedJune 3, 2019
May 1, 2019
3 months
May 28, 2019
May 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (4)
Group 1
ACTIVE COMPARATORA 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
ACTIVE COMPARATORA 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
ACTIVE COMPARATORA 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 4
PLACEBO COMPARATORA 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.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 19 to 72
- Enough cognitive ability to fill clinical assessment forms
- Agreed to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hilal Telli, MD
European University of Lefke
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor - Medical Doctor
Study Record Dates
First Submitted
May 28, 2019
First Posted
May 30, 2019
Study Start
June 1, 2013
Primary Completion
August 31, 2013
Study Completion
August 31, 2013
Last Updated
June 3, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
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.