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

Primary Purpose

Pain in Arm, Unspecified, Tenosynovitis Elbow, Lateral Epicondylitis (Tennis Elbow) Bilateral

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation (TENS)
Sham Transcutaneous Electrical Nerve Stimulation (TENS)
Kinesio Taping
Sham Kinesio Taping
Sponsored by
European University of Lefke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain in Arm, Unspecified focused on measuring Kinesio Taping, Lateral epicondylitis, Tennis elbow, TENS

Eligibility Criteria

19 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2019
    Last Updated
    May 30, 2019
    Sponsor
    European University of Lefke
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03968796
    Brief Title
    Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis
    Official Title
    TENS and Kinesio Tape for Treatment Lateral Epicondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2013 (Actual)
    Primary Completion Date
    August 31, 2013 (Actual)
    Study Completion Date
    August 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    European University of Lefke

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain in Arm, Unspecified, Tenosynovitis Elbow, Lateral Epicondylitis (Tennis Elbow) Bilateral
    Keywords
    Kinesio Taping, Lateral epicondylitis, Tennis elbow, TENS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group 3
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group 4
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Transcutaneous Electrical Nerve Stimulation (TENS)
    Intervention Type
    Other
    Intervention Name(s)
    Sham Transcutaneous Electrical Nerve Stimulation (TENS)
    Intervention Type
    Other
    Intervention Name(s)
    Kinesio Taping
    Intervention Type
    Other
    Intervention Name(s)
    Sham Kinesio Taping
    Primary Outcome Measure Information:
    Title
    Pain-free grip strength
    Description
    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.
    Time Frame
    12 week
    Title
    Pain severity at rest, night and forced wrist extension test
    Description
    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.
    Time Frame
    12 week
    Title
    Pressure pain threshold
    Description
    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.
    Time Frame
    12 week
    Title
    Patient-rated tennis elbow evaluation (PRTEE)
    Description
    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.
    Time Frame
    12 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hilal Telli, MD
    Organizational Affiliation
    European University of Lefke
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.

    Learn more about this trial

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

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