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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05019781
Other study ID # 15082021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date March 31, 2018

Study information

Verified date August 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effectiveness of Kinesio taping (KT) on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players. One hundred seventeen participants who were professional violinists for at least two years were randomized to receive either therapeutic tape application (KT group), a sham tape application (placebo group) or no application (control group) for one week. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) in one week. The secondary outcomes were the Visual Analogue Scale (VAS), the Purdue Pegboard Test, grip and pinch strength. Outcome measures were performed at baseline, immediately after the intervention, and one week later (follow-up). Participants were asked to play the "Violin Concerto No.2, Op.35", and pre-and post-performance pain and grip and pinch strength were assessed.


Description:

Kinesio tape (KT), an alternative taping technique, is a method consisting of a tape with elastic properties and stretching capabilities used to treat pain or prevent injuries in conjunction with exercise.It has been concluded that KT intervention might not be helpful to reduce dystonic patterns or improve playing ability in musicians with focal hand dystonia. However, there is no enough study to conclude the effectiveness of KT application in Playing-related musculoskeletal disorders. Therefore, this study aimed to investigate the effect of KT on playing-related pain, upper extremity and hand function, grip and pinch strength in violin players compared to placebo KT application and control. As a secondary outcome, the investigators explored whether the pre-and post-performance effect of the KT on playing-related pain and grip and pinch strength.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date March 31, 2018
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. aged between 18 and 35 years; 2. professionally playing violin at least for two years; 3. having playing-related musculoskeletal pain at neck and upper extremity [Visual Analogue Scale (VAS) =3] 4. ability to read and write in Turkish; and 5. able to follow simple instructions. Exclusion Criteria: 1. having significant musculoskeletal, neurologic, or cardiovascular disorders; 2. a history of surgery on the upper limbs in the previous six months; 3. the initiation of any analgesic intervention for musculoskeletal pain within the previous six weeks; 4. known allergies to tape; and 5. participation in physiotherapy and rehabilitation program in the last six months.

Study Design


Intervention

Other:
Therapeutic tape
Tape was applied to sternocleidomastoid, upper trapezius, deltoid, flexor palmaris longus muscles as suggested by Kase et al. (Kase, Wallis, Kase, & Association, 2003). The tape was applied to the left side of the participants while sitting position because the violin is traditionally played by placing it on the left shoulder, balancing the neck using the left hand, and bowing with the right arm.
Placebo tape
The placebo tape was applied transverse to the muscle groups in two levels (a point of 10 cm above to wrist and elbow) with no tension when the participants were sitting position with the shoulder flexed at 90°, and the elbow flexed at 90°.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Upper extremity function The Disabilities of the Arm, Shoulder and Hand score is a self-administered questionnaire designed to evaluate single or multiple disorders and impairment levels in the upper limbs. It comprises 30 core questions and optional eight questions, which are scored on a 5-point Likert scale (no difficulty - unable). The cumulative score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability. Baseline
Secondary Upper extremity function The Disabilities of the Arm, Shoulder and Hand score is a self-administered questionnaire designed to evaluate single or multiple disorders and impairment levels in the upper limbs. It comprises 30 core questions and optional eight questions, which are scored on a 5-point Likert scale (no difficulty - unable). The cumulative score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability. Follow-up (one week later)
Secondary Playing-related pain Playing-related pain was measured using the Visual Analogue Scale (VAS). The participants were asked to indicate their perceived pain while playing the violin on the 10 cm line between no pain and terrible pain. The score was determined by measuring the distance on a 10 cm line using a ruler. Baseline
Secondary Playing-related pain Playing-related pain was measured using the Visual Analogue Scale (VAS). The participants were asked to indicate their perceived pain while playing the violin on the 10 cm line between no pain and terrible pain. The score was determined by measuring the distance on a 10 cm line using a ruler. Immediately after the intervention
Secondary Playing-related pain Playing-related pain was measured using the Visual Analogue Scale (VAS). The participants were asked to indicate their perceived pain while playing the violin on the 10 cm line between no pain and terrible pain. The score was determined by measuring the distance on a 10 cm line using a ruler. Follow-up (one week later)
Secondary Playing-related pain Playing-related pain was measured using the Visual Analogue Scale (VAS). The participants were asked to indicate their perceived pain while playing the violin on the 10 cm line between no pain and terrible pain. The score was determined by measuring the distance on a 10 cm line using a ruler. After one-week intervention (before playing Violin Concerto No.2, Op.35)
Secondary Playing-related pain Playing-related pain was measured using the Visual Analogue Scale (VAS). The participants were asked to indicate their perceived pain while playing the violin on the 10 cm line between no pain and terrible pain. The score was determined by measuring the distance on a 10 cm line using a ruler. After one-week intervention (after playing Violin Concerto No.2, Op.35)
Secondary Hand function The Purdue Pegboard Test was used to measure manual dexterity of both dominant and non-dominant hands. Participants were asked to place a pin in a vertical array of holes first with the right hand, then with the left hand, and following with both hands as quickly as possible in 30 s. In the final subtest, participants were asked to assemble a metal pin, washer, collar, and the second washer with both hands with the highest speed possible during 60 s. Baseline
Secondary Hand function The Purdue Pegboard Test was used to measure manual dexterity of both dominant and non-dominant hands. Participants were asked to place a pin in a vertical array of holes first with the right hand, then with the left hand, and following with both hands as quickly as possible in 30 s. In the final subtest, participants were asked to assemble a metal pin, washer, collar, and the second washer with both hands with the highest speed possible during 60 s. Immediately after the intervention
Secondary Hand function The Purdue Pegboard Test was used to measure manual dexterity of both dominant and non-dominant hands. Participants were asked to place a pin in a vertical array of holes first with the right hand, then with the left hand, and following with both hands as quickly as possible in 30 s. In the final subtest, participants were asked to assemble a metal pin, washer, collar, and the second washer with both hands with the highest speed possible during 60 s. Follow-up (one week later)
Secondary Hand function The Purdue Pegboard Test was used to measure manual dexterity of both dominant and non-dominant hands. Participants were asked to place a pin in a vertical array of holes first with the right hand, then with the left hand, and following with both hands as quickly as possible in 30 s. In the final subtest, participants were asked to assemble a metal pin, washer, collar, and the second washer with both hands with the highest speed possible during 60 s. After one-week intervention (before playing Violin Concerto No.2, Op.35)
Secondary Hand function The Purdue Pegboard Test was used to measure manual dexterity of both dominant and non-dominant hands. Participants were asked to place a pin in a vertical array of holes first with the right hand, then with the left hand, and following with both hands as quickly as possible in 30 s. In the final subtest, participants were asked to assemble a metal pin, washer, collar, and the second washer with both hands with the highest speed possible during 60 s. After one-week intervention (after playing Violin Concerto No.2, Op.35)
Secondary Grip and Pinch Strength A hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer) is a practical tool to assess the hand's grip strength and pinch strength. For assessment of grip strength, the handle of the meter was adjusted at the second position. Each participant was instructed to squeeze the dynamometer's handle as hard as possible while positioning with the trunk upright; elbow flexed to 90°, forearm, and wrist in a neutral position. For assessment of pinch strength, the examiner held the distal end of the pinch gauge while the participant was instructed to squeeze the thumb pad according to different types of pinch grips (tip pinch, palmar pinch, key pinch). Assessments were repeated for the dominant and non-dominant hands. The mean values of the three grip strength and pinch strength measurements (kilogram-force) were calculated. Baseline
Secondary Grip and Pinch Strength A hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer) is a practical tool to assess the hand's grip strength and pinch strength. For assessment of grip strength, the handle of the meter was adjusted at the second position. Each participant was instructed to squeeze the dynamometer's handle as hard as possible while positioning with the trunk upright; elbow flexed to 90°, forearm, and wrist in a neutral position. For assessment of pinch strength, the examiner held the distal end of the pinch gauge while the participant was instructed to squeeze the thumb pad according to different types of pinch grips (tip pinch, palmar pinch, key pinch). Assessments were repeated for the dominant and non-dominant hands. The mean values of the three grip strength and pinch strength measurements (kilogram-force) were calculated. Immediately after the intervention
Secondary Grip and Pinch Strength A hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer) is a practical tool to assess the hand's grip strength and pinch strength. For assessment of grip strength, the handle of the meter was adjusted at the second position. Each participant was instructed to squeeze the dynamometer's handle as hard as possible while positioning with the trunk upright; elbow flexed to 90°, forearm, and wrist in a neutral position. For assessment of pinch strength, the examiner held the distal end of the pinch gauge while the participant was instructed to squeeze the thumb pad according to different types of pinch grips (tip pinch, palmar pinch, key pinch). Assessments were repeated for the dominant and non-dominant hands. The mean values of the three grip strength and pinch strength measurements (kilogram-force) were calculated. Follow up (one week later)
Secondary Grip and Pinch Strength A hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer) is a practical tool to assess the hand's grip strength and pinch strength. For assessment of grip strength, the handle of the meter was adjusted at the second position. Each participant was instructed to squeeze the dynamometer's handle as hard as possible while positioning with the trunk upright; elbow flexed to 90°, forearm, and wrist in a neutral position. For assessment of pinch strength, the examiner held the distal end of the pinch gauge while the participant was instructed to squeeze the thumb pad according to different types of pinch grips (tip pinch, palmar pinch, key pinch). Assessments were repeated for the dominant and non-dominant hands. The mean values of the three grip strength and pinch strength measurements (kilogram-force) were calculated. After one-week intervention (before playing Violin Concerto No.2, Op.35)
Secondary Grip and Pinch Strength A hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer) is a practical tool to assess the hand's grip strength and pinch strength. For assessment of grip strength, the handle of the meter was adjusted at the second position. Each participant was instructed to squeeze the dynamometer's handle as hard as possible while positioning with the trunk upright; elbow flexed to 90°, forearm, and wrist in a neutral position. For assessment of pinch strength, the examiner held the distal end of the pinch gauge while the participant was instructed to squeeze the thumb pad according to different types of pinch grips (tip pinch, palmar pinch, key pinch). Assessments were repeated for the dominant and non-dominant hands. The mean values of the three grip strength and pinch strength measurements (kilogram-force) were calculated. After one-week intervention (after playing Violin Concerto No.2, Op.35)
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