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Trial record 1 of 1 for:    NCT03379636
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Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery

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ClinicalTrials.gov Identifier: NCT03379636
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Clinique Romande de Readaptation

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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Device: kinesiotape Device: sham tape Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : January 4, 2017

Arm Intervention/treatment
No Intervention: no tape
tests are realised without any shoulder tape
Experimental: kinesiotape
tests are realised with a kinesiotape applied according to Dr Kase model, over the deltoid muscle and over the acromioclavicular joint
Device: kinesiotape
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

Sham Comparator: sham tape
tests are realised with a sham tape, applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area
Device: sham tape
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 Measures :
  1. muscular activity [ Time Frame: 6 and 12 weeks post surgery ]

    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 :
  1. active range of motion [ Time Frame: 6 and 12 weeks post surgery ]
    shoulder flexion measured in degrees

  2. strength [ Time Frame: 6 and 12 weeks post surgery ]
    isometric strength at 90° of shoulder flexion, measured in kg

  3. pain [ Time Frame: 6 and 12 weeks post surgery ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379636


Sponsors and Collaborators
Clinique Romande de Readaptation
Investigators
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Study Chair: Bertrand Léger, PhD Clinique romande de réadaptation

Publications:
Kase K, Wallis J, Kase T: Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Keni-Kai information; 2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clinique Romande de Readaptation
ClinicalTrials.gov Identifier: NCT03379636     History of Changes
Other Study ID Numbers: CliniqueRR-006
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinique Romande de Readaptation:
Athletic tape
Electromyography
Rehabilitation
Shoulder

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries