Lateral Epicondylitis
Conditions
Keywords
Kinesio taping, lateral epicondylitis, tennis elbow, treatment
Brief summary
The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.
Detailed description
Lateral epicondylitis or tennis elbow is a often-encountered disorder of elbow which is characterized by tenderness and pain over lateral epicondylitis of humerus and grip weakness. The annual incidence of lateral epicondylitis has been reported to be %1-3 in general population. Lateral epicondylitis is commonly associated with repetitive overuse of wrist, activities including strong grip which in turn cause microtears and degenerative changes over the common origin of wrist and finger extensors on lateral epicondyle. New researches have shown that the underlying mechanism is degenerative rather than inflammatory. It has been proposed that the cause of pain may be mechanical discontinuity of collagen fibers or biochemical irritation that results from damaged tendon tissue that activates nociceptors. It has been suggested that eccentric loading has been shown to assist with tendon rehabilitation by improving collagen alignment and stimulating collagen cross-linkage formation, both of which can improve tensile strength. Kinesio taping (KT) which is a new application of adhesive taping was designed by Kenzo Kase to avoid unwanted effects of conventional taping such as restricting range of motion (ROM) and limiting functional activities. The recommended tape application methods are outlined in 'Clinical Therapeutic Applications of the Kinesio Taping Method' 8. Elastic therapeutic tape has been designed to allow for a longitudinal stretch of up to 140% of its resting length and has been designed to approximate the elastic qualities of the human skin. In particular, the application of the tape over stretched muscle to create convolutions in the skin has been hypothesized to reduce pressure in the mechanoreceptors below the dermis, thereby decreasing nociceptive stimuli. Another mechanism which is claimed by the proponent of the tape is that convolutions are raised ridges of the tape and the skin that are thought to decompress underlying structures and allow for enhanced circulation by increased subcutaneous space. In the last few years, the use of KT has become increasingly popular in rehabilitation programs as an adjunct in the treatment. However, scientific evidence about its effect is insufficient. The aim of this study is to compare the effects of kinesiology taping with exercise, sham taping with exercise and exercise alone for lateral epicondylitis.
Interventions
Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis
Sham taping will be performed without using any technique
Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .
Sponsors
Study design
Masking description
To ensure group concealment, randomization will be done by using opaque, sealed envelopes which the assessors will be blinded to
Intervention model description
Parallel Assignment
Eligibility
Inclusion criteria
1. Having had symptoms less than 12 weeks 2. Tenderness and pain over lateral epicondylitis 3. Provocation of the lateral elbow pain with at least one of the following tests - resisted middle finger extension (Maudley's test), resisted wrist extension or passive stretch of wrist extensors (Mill's test).
Exclusion criteria
1. Cervical spondylosis or radiculopathy 2. Diabetes mellitus 3. Neuropathy 4. Arthritis in the upper extremities 5. History of injection and physical therapy for lateral epicondylitis within the last three months 6. Pregnancy 7. History of surgery or acute trauma in the elbow 8. Allergy to tape
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Rated Tennis Elbow Evaluation (PRTEE) | 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment) | PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale \[5 items\] (0 = no pain, 10 = worst imaginable) 2) Function subscale \[Specific activities - 6 items, Usual activities - 4 items\] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) at Rest | 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment) | Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain. |
| Visual Analogue Scale (VAS) at Daily Activity | 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment) | Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain. |
| The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment) | The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability. |
| Painless Grip Strength | 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment) | Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded. |
| Grip Strength | 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment) | Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded. |
| Visual Analogue Scale (VAS) at Night | 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment) | Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Recruitment period was March 2017-May 2017 Setting: A university hospital outpatient clinics
Pre-assignment details
Number of patients assessed for eligibility was 41. Among them,8 participants were excluded due to being inappropiate for the inclusion criteria (2 had concomittant radiculopathy, 2 were diagnosed as cubital tunnel syndrome, 2 were diagnosed as carpal tunnel syndrome and 2 of them had duration of symptoms were more than 12 weeks)
Participants by arm
| Arm | Count |
|---|---|
| Kinesiotaping Kinesio taping by using space and fascia correction techniques on forearm of the patients for lateral epicondylitis treatment will be applied every 3 days for 2 weeks in addition to exercises.
Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. | 10 |
| Sham Taping Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises
Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. | 10 |
| Control Only-exercises group: Stretching and strengthening exercises of wrist
Exercise: Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Kinesiotaping | Sham Taping | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Age, Continuous | 46.5 years | 45 years | 41.5 years | 45 years |
| Duration of Symptoms | 7 weeks | 8 weeks | 7 weeks | 8 weeks |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Nirschl Score | 5 Scores on a scale | 4.5 Scores on a scale | 5 Scores on a scale | 5 Scores on a scale |
| PRTEE (Patient rated tennis elbow evaluation) | 49 units on a scale | 53.75 units on a scale | 49.25 units on a scale | 51 units on a scale |
| Region of Enrollment Turkey | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 9 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 1 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Patient Rated Tennis Elbow Evaluation (PRTEE)
PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale \[5 items\] (0 = no pain, 10 = worst imaginable) 2) Function subscale \[Specific activities - 6 items, Usual activities - 4 items\] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).
Time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | Patient Rated Tennis Elbow Evaluation (PRTEE) | After Treatment | 26.5 units on a scale |
| Kinesiotaping | Patient Rated Tennis Elbow Evaluation (PRTEE) | Baseline | 49 units on a scale |
| Kinesiotaping | Patient Rated Tennis Elbow Evaluation (PRTEE) | 4 weeks After Treatment | 29.25 units on a scale |
| Sham Taping | Patient Rated Tennis Elbow Evaluation (PRTEE) | After Treatment | 50.25 units on a scale |
| Sham Taping | Patient Rated Tennis Elbow Evaluation (PRTEE) | Baseline | 53.75 units on a scale |
| Sham Taping | Patient Rated Tennis Elbow Evaluation (PRTEE) | 4 weeks After Treatment | 47.5 units on a scale |
| Control | Patient Rated Tennis Elbow Evaluation (PRTEE) | Baseline | 49.25 units on a scale |
| Control | Patient Rated Tennis Elbow Evaluation (PRTEE) | 4 weeks After Treatment | 44.5 units on a scale |
| Control | Patient Rated Tennis Elbow Evaluation (PRTEE) | After Treatment | 46.25 units on a scale |
Grip Strength
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded.
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | Grip Strength | After Treatment | 22.5 kg |
| Kinesiotaping | Grip Strength | 4 weeks After Treatment | 25 kg |
| Kinesiotaping | Grip Strength | Immediate Effect | 22 kg |
| Kinesiotaping | Grip Strength | Baseline | 20 kg |
| Sham Taping | Grip Strength | Baseline | 19.5 kg |
| Sham Taping | Grip Strength | Immediate Effect | 19.5 kg |
| Sham Taping | Grip Strength | 4 weeks After Treatment | 21 kg |
| Sham Taping | Grip Strength | After Treatment | 20 kg |
| Control | Grip Strength | 4 weeks After Treatment | 24 kg |
| Control | Grip Strength | Baseline | 23.5 kg |
| Control | Grip Strength | Immediate Effect | NA kg |
| Control | Grip Strength | After Treatment | 24 kg |
Painless Grip Strength
Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded.
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | Painless Grip Strength | Baseline | 14 kg |
| Kinesiotaping | Painless Grip Strength | Immediate Effect | 17 kg |
| Kinesiotaping | Painless Grip Strength | After Treatment | 17.5 kg |
| Kinesiotaping | Painless Grip Strength | 4 weeks After Treatment | 20 kg |
| Sham Taping | Painless Grip Strength | 4 weeks After Treatment | 14.5 kg |
| Sham Taping | Painless Grip Strength | Baseline | 12 kg |
| Sham Taping | Painless Grip Strength | After Treatment | 13 kg |
| Sham Taping | Painless Grip Strength | Immediate Effect | 13 kg |
| Control | Painless Grip Strength | 4 weeks After Treatment | 14.5 kg |
| Control | Painless Grip Strength | Immediate Effect | NA kg |
| Control | Painless Grip Strength | After Treatment | 15 kg |
| Control | Painless Grip Strength | Baseline | 13 kg |
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability.
Time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | After Treatment | 29.5 score on a scale |
| Kinesiotaping | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | Baseline | 50 score on a scale |
| Kinesiotaping | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | 4 weeks After Treatmentt | 18.18 score on a scale |
| Sham Taping | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | After Treatment | 47.72 score on a scale |
| Sham Taping | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | Baseline | 46.57 score on a scale |
| Sham Taping | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | 4 weeks After Treatmentt | 47.72 score on a scale |
| Control | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | Baseline | 46.59 score on a scale |
| Control | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | 4 weeks After Treatmentt | 39.75 score on a scale |
| Control | The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) | After Treatment | 39.77 score on a scale |
Visual Analogue Scale (VAS) at Daily Activity
Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | Visual Analogue Scale (VAS) at Daily Activity | Baseline | 6.5 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Daily Activity | Immediate Effect | 5 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Daily Activity | After Treatment | 3 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Daily Activity | 4 weeks After Treatment | 3 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Daily Activity | 4 weeks After Treatment | 6.5 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Daily Activity | Baseline | 7.5 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Daily Activity | After Treatment | 7 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Daily Activity | Immediate Effect | 7 score on a scale |
| Control | Visual Analogue Scale (VAS) at Daily Activity | 4 weeks After Treatment | 5.5 score on a scale |
| Control | Visual Analogue Scale (VAS) at Daily Activity | Immediate Effect | NA score on a scale |
| Control | Visual Analogue Scale (VAS) at Daily Activity | After Treatment | 5 score on a scale |
| Control | Visual Analogue Scale (VAS) at Daily Activity | Baseline | 7 score on a scale |
Visual Analogue Scale (VAS) at Night
Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Time frame: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | Visual Analogue Scale (VAS) at Night | After Treatment | 0 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Night | Before Treatment | 2.5 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Night | 4 weeks After Treatment | 0 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Night | After Treatment | 2 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Night | Before Treatment | 2.5 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Night | 4 weeks After Treatment | 2 score on a scale |
| Control | Visual Analogue Scale (VAS) at Night | Before Treatment | 3.5 score on a scale |
| Control | Visual Analogue Scale (VAS) at Night | 4 weeks After Treatment | 0 score on a scale |
| Control | Visual Analogue Scale (VAS) at Night | After Treatment | 1 score on a scale |
Visual Analogue Scale (VAS) at Rest
Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.
Time frame: 0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Kinesiotaping | Visual Analogue Scale (VAS) at Rest | After Treatment | 0 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Rest | Baseline | 1.5 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Rest | 4 weeks After Treatment | 0 score on a scale |
| Kinesiotaping | Visual Analogue Scale (VAS) at Rest | Immediate Effect | 0 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Rest | After Treatment | 0.5 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Rest | Immediate Effect | 1.5 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Rest | Baseline | 1.5 score on a scale |
| Sham Taping | Visual Analogue Scale (VAS) at Rest | 4 weeks After Treatment | 1 score on a scale |
| Control | Visual Analogue Scale (VAS) at Rest | Immediate Effect | NA score on a scale |
| Control | Visual Analogue Scale (VAS) at Rest | Baseline | 3 score on a scale |
| Control | Visual Analogue Scale (VAS) at Rest | 4 weeks After Treatment | 1.5 score on a scale |
| Control | Visual Analogue Scale (VAS) at Rest | After Treatment | 1 score on a scale |