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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
Clinique Romande de Readaptation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Athletic tape, Electromyography, Rehabilitation, Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 15, 2017
    Last Updated
    December 21, 2017
    Sponsor
    Clinique Romande de Readaptation
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    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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