Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kinesiotape
sham tape
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Athletic tape, Electromyography, Rehabilitation, Shoulder
Eligibility Criteria
Inclusion Criteria:
- adult subject who had a surgery less than 6 weeks ago after a shoulder rotator cuff tear
Exclusion Criteria:
- re-tear of the rotator cuff, associated neurological lesion, concomitant cervical or elbow lesion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Sham Comparator
Arm Label
no tape
kinesiotape
sham tape
Arm Description
tests are realised without any shoulder tape
tests are realised with a kinesiotape applied according to Dr Kase model, over the deltoid muscle and over the acromioclavicular joint
tests are realised with a sham tape, applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area
Outcomes
Primary Outcome Measures
muscular activity
Activity of upper trapezius, anterior, middle and posterior parts of deltoid ans of infraspinatus.
The mean amplitude of electromyographic (EMG) signal, expressed as a percentage of reference voluntary contraction (RVC) is used
Secondary Outcome Measures
active range of motion
shoulder flexion measured in degrees
strength
isometric strength at 90° of shoulder flexion, measured in kg
pain
shoulder pain intensity measured with a 100-mm visual analog scale (0: no pain; 100: worst imaginable pain). Shoulder pain intensity was assessed at end-point of ROM and after isometric force assessment. This measure is known for its excellent reliability.
Full Information
NCT ID
NCT03379636
First Posted
December 15, 2017
Last Updated
December 21, 2017
Sponsor
Clinique Romande de Readaptation
1. Study Identification
Unique Protocol Identification Number
NCT03379636
Brief Title
Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery
Official Title
Immediate and Short-term Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery: A Cross-over Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
January 4, 2017 (Actual)
Study Completion Date
January 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Romande de Readaptation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Kinesiotape (KT) is widely used in musculoskeletal rehabilitation as an adjuvant to treatment but minimal evidence supports its use. The aim of this study is to determine the immediate and short-term effects of shoulder KT on muscular activity, mobility, strength and pain after rotator cuff surgery. Our hypotheses were that KT should not improve muscle function, mobility, strength or pain in a clinically meaningful way.
Methods: Thirty-nine subjects with shoulder rotator cuff surgery were tested 6 and 12 weeks post-surgery, without tape, with KT and with a sham tape (ST). KT and ST were applied in a randomized order. For each condition, muscular activity of upper trapezius, three parts of deltoid and infraspinatus during shoulder flexion, range of motion (ROM) and pain intensity were assessed. At 12 weeks, isometric strength at 90° of shoulder flexion, with related muscular activity and pain intensity were also measured. Subjects maintained the last tape applied for three days and recorded pain intensity at wake-up and during the day.
Detailed Description
Sample size was calculated a priori using STATA Version 13.1 software (StataCorp, College Station, USA). Based on data of muscular activity from the article of Hsu et al 20 and considering a statistical power of 80% and a Type I error of .05, a need for at least 36 subjects was necessary to highlight a group difference. We finally enrolled 39 subjects between January 2013 and October 2016. Informed written consent was obtained from all subjects and all rights of the participants were protected.
Testing procedure:
Subjects were invited to come at the Clinique romande de réadaptation in Sion (Switzerland) on two occasions: 6 and 12 weeks after their surgery. Each time, they first filled the French version of the quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in order to assess their physical function and symptoms. This 11-item questionnaire is valid, reliable and responsive in shoulder disorders.14, 17 They also estimated their pain intensity at rest using a 100-mm visual analogue scale (VAS).
A baseline measurement was then realized, without any tape (NT). The subjects were seated on a chair without resting on the backrest, the arms along the body. Shoulder rotation was neutral, elbow extended and forearm in neutral position. The subjects had to lift their arm in the sagittal plane as high as possible, hold the position for 5 seconds and then return at initial position. The movement was repeated once after one minute rest.
During the second session, at 12 weeks, the subjects realized in addition a maximal voluntary isometric contraction measure (MVIC). The measure was realized at 90° of shoulder flexion, neutral rotation, elbow extended, pronation of the forearm and fist closed. The strap of the dynamometer was applied at the level of the wrist.5 The subjects had to develop the maximal force during a 5-seconds period. After one minute rest, a second trial took place. The whole session was videotaped for further analysis. At the end of the testing sessions, the subjects were instructed not to remove the last tape applied for 72 hours.
The sequence always began with the NT condition. Then the two tapes were applied in a randomized order and the subjects repeated the same procedure. Group allocation, KT vs ST group, corresponded to the last tape the subject received and had to wear for the next three days. A computer block (n=8) randomization process was performed and sealed opaque envelopes were used. The physiotherapist who applied the tape was not blinded but he did not participate in outcome assessment. The main investigator (first author) who collected the data was blind as subjects wore a long-sleeve shirt which hid the tape and the tape was administered behind a folding screen.
Statistical analysis:
Comparisons between baseline characteristics of the two groups were computed using nonparametric tests comparing the medians for continuous variables or chi-squared tests for categorical variables.
The outcome variables measured during the mobility and the strength tests were compared between the three taping conditions. For the VAS outcomes during the three days after tape application, comparisons were realized between KT and ST solely. As the distributions of the outcome variables were not normal, nonparametric tests comparing the medians were performed. All analyses were done using Stata 13.1 software.
As multiple comparisons were realized, the level of statistical significance was set at P<.017 (.05/3) for the comparisons between the three conditions of tape (comparison of NT vs KT, NT vs ST, KT vs ST). For comparison between KT group and ST group only, the level of significance was set at P<.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Athletic tape, Electromyography, Rehabilitation, Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All subjects were tested without tape, with kinesiotape (KT) and with a sham tape (ST). KT and ST were applied in a randomized order.
The sequence always began with the NT condition. Then the two tapes were applied in a randomized order and the subjects repeated the same procedure. Group allocation, KT vs ST group, corresponded to the last tape the subject received and had to wear for the next three days. A computer block (n=8) randomization process was performed and sealed opaque envelopes were used.
Masking
InvestigatorOutcomes Assessor
Masking Description
The physiotherapist who applied the tape was not blinded but he did not participate in outcome assessment. The main investigator who collected the data was blind as subjects wore a long-sleeve shirt which hid the tape and the tape was administered behind a folding screen.
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no tape
Arm Type
No Intervention
Arm Description
tests are realised without any shoulder tape
Arm Title
kinesiotape
Arm Type
Experimental
Arm Description
tests are realised with a kinesiotape applied according to Dr Kase model, over the deltoid muscle and over the acromioclavicular joint
Arm Title
sham tape
Arm Type
Sham Comparator
Arm Description
tests are realised with a sham tape, applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area
Intervention Type
Device
Intervention Name(s)
kinesiotape
Intervention Description
Application of an elastic beige 5-cm width Leukotape®K (BSN medical, Germany). The first strip, a Y-strip, was applied with 10% to 15% of tension over the deltoid muscle, from origin to insertion with the first tail along the anterior deltoid while the arm was externally rotated and horizontally abducted. The second tail was applied along the posterior deltoid with the arm horizontally adducted and internally rotated. A second strip, an I-strip, was applied for mechanical correction, transversally in the sagittal plane over the acromioclavicular joint with a downward pressure applied to the KT, the arm being at trunk side
Intervention Type
Device
Intervention Name(s)
sham tape
Intervention Description
a rigid Leukotape®Classic (BSN medical, Germany) was used. A 5-cm strip was applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area.
Primary Outcome Measure Information:
Title
muscular activity
Description
Activity of upper trapezius, anterior, middle and posterior parts of deltoid ans of infraspinatus.
The mean amplitude of electromyographic (EMG) signal, expressed as a percentage of reference voluntary contraction (RVC) is used
Time Frame
6 and 12 weeks post surgery
Secondary Outcome Measure Information:
Title
active range of motion
Description
shoulder flexion measured in degrees
Time Frame
6 and 12 weeks post surgery
Title
strength
Description
isometric strength at 90° of shoulder flexion, measured in kg
Time Frame
6 and 12 weeks post surgery
Title
pain
Description
shoulder pain intensity measured with a 100-mm visual analog scale (0: no pain; 100: worst imaginable pain). Shoulder pain intensity was assessed at end-point of ROM and after isometric force assessment. This measure is known for its excellent reliability.
Time Frame
6 and 12 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult subject who had a surgery less than 6 weeks ago after a shoulder rotator cuff tear
Exclusion Criteria:
re-tear of the rotator cuff, associated neurological lesion, concomitant cervical or elbow lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Léger, PhD
Organizational Affiliation
Clinique romande de réadaptation
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
Kase K, Wallis J, Kase T: Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Keni-Kai information; 2003.
Results Reference
background
PubMed Identifier
30134883
Citation
Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.
Results Reference
derived
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Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery
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