Trial Outcomes & Findings for Kinesiotaping in Lateral Epicondylitis (NCT NCT03074500)

Last Updated: 2019-10-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)

Results posted on

2019-10-03

Participant Flow

Recruitment period was March 2017-May 2017 Setting: A university hospital outpatient clinics

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)

Participant milestones

Participant milestones
Measure	Kinesiotaping Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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. .	Control 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. .	Sham Taping Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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. .
Overall Study STARTED	11	11	11
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Kinesiotaping Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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. .	Control 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. .	Sham Taping Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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. .
Overall Study Lost to Follow-up	1	0	0
Overall Study Lack of Efficacy	0	1	0
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Kinesiotaping in Lateral Epicondylitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kinesiotaping n=10 Participants 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.	Sham Taping n=10 Participants 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.	Control n=10 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	46.5 years n=5 Participants	45 years n=7 Participants	41.5 years n=5 Participants	45 years n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment Turkey	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
Duration of Symptoms	7 weeks n=5 Participants	8 weeks n=7 Participants	7 weeks n=5 Participants	8 weeks n=4 Participants
Nirschl Score	5 Scores on a scale n=5 Participants	4.5 Scores on a scale n=7 Participants	5 Scores on a scale n=5 Participants	5 Scores on a scale n=4 Participants
PRTEE (Patient rated tennis elbow evaluation)	49 units on a scale n=5 Participants	53.75 units on a scale n=7 Participants	49.25 units on a scale n=5 Participants	51 units on a scale n=4 Participants

PRIMARY outcome

Timeframe: 0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
Patient Rated Tennis Elbow Evaluation (PRTEE) Baseline	49 units on a scale Interval 43.88 to 73.0	53.75 units on a scale Interval 48.62 to 63.0	49.25 units on a scale Interval 41.0 to 57.5
Patient Rated Tennis Elbow Evaluation (PRTEE) After Treatment	26.5 units on a scale Interval 16.87 to 39.75	50.25 units on a scale Interval 42.0 to 58.37	46.25 units on a scale Interval 37.5 to 54.12
Patient Rated Tennis Elbow Evaluation (PRTEE) 4 weeks After Treatment	29.25 units on a scale Interval 16.37 to 29.25	47.5 units on a scale Interval 41.37 to 61.37	44.5 units on a scale Interval 38.87 to 53.62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) Baseline	50 score on a scale Interval 41.5 to 74.43	46.57 score on a scale Interval 38.6 to 62.49	46.59 score on a scale Interval 33.81 to 57.39
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) After Treatment	29.5 score on a scale Interval 10.4 to 59.7	47.72 score on a scale Interval 38.04 to 53.97	39.77 score on a scale Interval 33.52 to 49.42
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) 4 weeks After Treatmentt	18.18 score on a scale Interval 4.55 to 34.1	47.72 score on a scale Interval 34.62 to 56.81	39.75 score on a scale Interval 31.81 to 46.59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
Visual Analogue Scale (VAS) at Rest Baseline	1.5 score on a scale Interval 0.0 to 3.25	1.5 score on a scale Interval 0.0 to 3.25	3 score on a scale Interval 0.0 to 4.0
Visual Analogue Scale (VAS) at Rest Immediate Effect	0 score on a scale Interval 0.0 to 0.5	1.5 score on a scale Interval 0.0 to 3.25	NA score on a scale Immediate effect assessments of tapings are not applicable to control group.
Visual Analogue Scale (VAS) at Rest After Treatment	0 score on a scale Interval 0.0 to 0.25	0.5 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 0.0 to 3.5
Visual Analogue Scale (VAS) at Rest 4 weeks After Treatment	0 score on a scale Interval 0.0 to 0.0	1 score on a scale Interval 0.0 to 3.25	1.5 score on a scale Interval 0.75 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
Visual Analogue Scale (VAS) at Daily Activity Baseline	6.5 score on a scale Interval 5.0 to 7.25	7.5 score on a scale Interval 6.75 to 8.0	7 score on a scale Interval 5.0 to 7.0
Visual Analogue Scale (VAS) at Daily Activity Immediate Effect	5 score on a scale Interval 1.5 to 6.25	7 score on a scale Interval 6.0 to 8.0	NA score on a scale Immediate effect assessments of tapings are not applicable to control group.
Visual Analogue Scale (VAS) at Daily Activity After Treatment	3 score on a scale Interval 2.0 to 5.0	7 score on a scale Interval 5.75 to 8.0	5 score on a scale Interval 5.0 to 7.0
Visual Analogue Scale (VAS) at Daily Activity 4 weeks After Treatment	3 score on a scale Interval 1.75 to 5.25	6.5 score on a scale Interval 4.75 to 7.25	5.5 score on a scale Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
Visual Analogue Scale (VAS) at Night Before Treatment	2.5 score on a scale Interval 0.0 to 4.5	2.5 score on a scale Interval 0.0 to 3.5	3.5 score on a scale Interval 0.0 to 5.75
Visual Analogue Scale (VAS) at Night After Treatment	0 score on a scale Interval 0.0 to 0.25	2 score on a scale Interval 0.0 to 3.5	1 score on a scale Interval 0.0 to 3.25
Visual Analogue Scale (VAS) at Night 4 weeks After Treatment	0 score on a scale Interval 0.0 to 0.0	2 score on a scale Interval 0.0 to 3.25	0 score on a scale Interval 0.0 to 3.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
Painless Grip Strength Baseline	14 kg Interval 8.0 to 19.75	12 kg Interval 2.0 to 25.0	13 kg Interval 9.5 to 20.5
Painless Grip Strength Immediate Effect	17 kg Interval 10.0 to 23.0	13 kg Interval 3.75 to 27.75	NA kg Immediate effect assessments of tapings are not applicable to control group.
Painless Grip Strength After Treatment	17.5 kg Interval 14.75 to 28.25	13 kg Interval 10.0 to 21.25	15 kg Interval 9.5 to 20.5
Painless Grip Strength 4 weeks After Treatment	20 kg Interval 17.0 to 28.75	14.5 kg Interval 10.0 to 24.5	14.5 kg Interval 9.5 to 20.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Kinesiotaping n=10 Participants Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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.	Sham Taping n=10 Participants Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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.	Control n=10 Participants 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. .
Grip Strength Baseline	20 kg Interval 14.75 to 27.5	19.5 kg Interval 14.75 to 30.25	23.5 kg Interval 15.0 to 28.25
Grip Strength Immediate Effect	22 kg Interval 16.5 to 29.25	19.5 kg Interval 14.5 to 32.5	NA kg Immediate effect assessments of tapings are not applicable to control group.
Grip Strength After Treatment	22.5 kg Interval 17.5 to 29.25	20 kg Interval 14.5 to 27.25	24 kg Interval 19.0 to 25.75
Grip Strength 4 weeks After Treatment	25 kg Interval 21.5 to 28.75	21 kg Interval 12.0 to 28.0	24 kg Interval 18.5 to 27.0

Adverse Events

Kinesiotaping

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Taping

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Kinesiotaping n=11 participants at risk Kinesio taping by using space correction and fascia correction techniques every 3 days for 2 weeks in addition to exercises Kinesio taping: Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis 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. No adverse effect occured.	Sham Taping n=11 participants at risk Sham taping without using any techniques every 3 days for 2 weeks in addition to exercises Sham taping: Sham taping will be performed without using any technique 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. No adverse effect occured.	Control n=11 participants at risk 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. No adverse effect occured.
Skin and subcutaneous tissue disorders Allergy to Tape	0.00% 0/11 • 6 weeks	9.1% 1/11 • Number of events 1 • 6 weeks	0.00% 0/11 • 6 weeks

Additional Information

Gulseren Derya Akyuz

Marmara University School of Medicine

Phone: +90 216 657 06 06

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place