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Effects of Kinesiotaping on Symptoms, Functional Limitations, and Underlying Deficits of Patients With Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rehabilitation program
Kinesiotaping
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinopathy focused on measuring elastic tape, kinesiology taping, physiotherapy, rotator cuff, shoulder pain, tendon injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria.

To be eligible, participants should have unilateral rotator cuff tendinopathy and to present one positive finding in each of the following categories:

  • Painful arc of movement during flexion or abduction;
  • Neer (sensitivity 0.78, specificity 0.58) or Kennedy-Hawkins impingement signs (sensitivity 0.74, specificity 0.57);
  • Pain on resisted external rotation, abduction or empty can test (sensitivity 0.69, specificity 0.62).

Exclusion Criteria.

Patients will be excluded if they have:

  • an open wound that compromises KT application;
  • had a previous shoulder surgery;
  • allergy or intolerance to KT;
  • adhesive capsulitis, defined as loss of passive shoulder ROM greater than 50%;
  • history of glenohumeral luxation or fracture to the shoulder girdle;
  • shoulder pain reproduced by cervical movements;
  • clinical signs of full-thickness RC tears identified by lag signs tests (drop, internal, and external rotation signs).

Sites / Locations

  • Center for Interdisciplinary Research in Rehabilitation and Social Integration Research (CIRRIS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rehabilitation program and kinesiotaping.

Rehabilitation program.

Arm Description

Each patient will attend 10 physiotherapy sessions over six. Patients from the Experimental group (KT group) will receive the same standardized rehabilitation program as control group (No-KT group) including manual therapy, movement training, stretching, muscular strengthening, and patient education. Only KT-group (experimental) will receive therapeutic KT added to the rehabilitation program. Kinesio® Tex Classic will be applied using a combination of techniques designed for RCTe and underlying symptoms following the instructions and principles described by Kase et al (2003). Kinesiotaping strips will be weaned gradually, according to the individual improvements of deficits evaluated weekly by the physiotherapist treating.

Each patient will attend 10 physiotherapy sessions over six. Patients allocated at the control group (No-KT group) will receive only the rehabilitation program, including manual therapy, movement training, stretching, muscular strengthening, and patient education. The rehabilitation program will be exactly the same applied to the experimental group (KT group).

Outcomes

Primary Outcome Measures

Functional Limitations (changes during treatment; from baseline to 6 months follow-up).
Functional limitations will be measured throughout treatment using "The Disabilities of the Arm, Shoulder, and Hand (DASH)". The DASH is a 30-item self-report questionnaire, designed to measure physical disability and symptoms of upper limbs disorders. A validated Canadian-French version will be used (Intraclass correlation coefficient (ICC)=0.93; standardized response mean (SRM)=1.35; minimal detectable change (MDC)=11.4 points; clinically important difference (CID)=10 points)
Symptoms (pain intensity; changes during treatment; from baseline to 6 months follow-up).
Since DASH has few questions related to pain, the Brief Pain Inventory (BPI), which is specific for assessing clinical pain, will also be added to assess changes during treatment. The BPI measures pain intensity on an 11-point numerical rating scale (0-10), according to it interference with sleep, mood, etc., during the last 24 hours (ICC >0.80). Only the 4 first questions, related to clinical pain, will be used.
Symptoms (shoulder disabilities; changes during treatment; from baseline to 6 months follow-up).
Because DASH is non-specific for shoulder, the "Western Ontario Rotator Cuff (WORC)" index will be added to assess changes at shoulder disabilities throughout treatment. The WORC is a reliable and responsive (ICC=0.96; SRM=1.54; MDC=12 points; CID=13 points) questionnaire designed to measure health-related-quality-of-life of patients affected by RC injuries.

Secondary Outcome Measures

Range of Motion
Active full and pain free range of motion in shoulder elevation in the frontal (abduction) and sagittal (flexion) planes will be measured using a digital inclinometer.
Acromiohumeral distance
Outcome measurements at rest and 60º of active abduction using an ultrasound scanner.
Maximal electromyographic (EMG) amplitude
Maximal EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.
Mean peak EMG amplitude
Mean peak EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.
Onset timing
Measurements at scaption (functional movement) using a slapping-ball task.

Full Information

First Posted
August 12, 2016
Last Updated
February 27, 2019
Sponsor
Laval University
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02881021
Brief Title
Effects of Kinesiotaping on Symptoms, Functional Limitations, and Underlying Deficits of Patients With Rotator Cuff Tendinopathy
Official Title
Effects of Kinesiotaping Added to a Rehabilitation Program for Patients With Rotator Cuff Tendinopathy: Protocol of a Single-blind Randomized Controlled Trial Addressing Symptoms, Functional Limitations, and Underlying Deficits.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
April 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Rotator cuff tendinopathy (RCTe) is the most frequent cause of shoulder pain, resulting in considerable losses to society and public resources. Muscle imbalance and inadequate sensorimotor control are deficits often associated with RCTe. Kinesiotaping (KT) is widely used by clinicians for rehabilitation of RCTe. While previous studies have examined the immediate effects of KT on shoulder injuries or the effects of KT as an isolated method of treatment, no published study has addressed its mid- and long-term effects when combined to a rehabilitation program for patients with RCTe. The primary objective of this randomised controlled trial (RCT) will be to assess the efficacy of therapeutic KT, added to a rehabilitation program, in reducing pain and disabilities in individuals with RCTe. Secondary objectives will look at the effects of KT on the underlying factors involved in shoulder control, such as muscular activity, acromiohumeral distance (AHD), and range of motion (ROM). Methods and analysis: A single-blind RCT will be conducted. Fifty-two participants, randomly allocated to one of two groups (KT or no-KT), will take part in a 6-week rehabilitation program. The KT-group will receive KT added to the rehabilitation program, whereas the no-KT group will receive only the rehabilitation program. Measurements will be taken at baseline, week-3, week-6, week-12 and 6-month. Primary outcomes will be symptoms and functional limitations assessed by the DASH questionnaire. Secondary outcomes will include shoulder ROM, AHD at rest and at 60º of abduction, and muscle activation during arm elevation. The added effects of KT will be assessed through a 2-way ANOVA for repeated measures. Discussion: Investigations with a high level of evidence are needed to determine scientific evidence-based concerning the efficacy of KT for the rehabilitation of individuals with RCTe. This RCT will be the first to assess the effectiveness of KT added into a conventional RP for patients with RCTe, addressing underlying factors that could explain the possible benefits of this method, in a mid- and long-term. Results may contribute to build solid evidence on the addition of KT in a physiotherapy intervention for this population. Ethics and Dissemination: Ethics approval was obtained from the Ethics Committee of Quebec Rehabilitation Institute (IRDPQ) of the CIUSS-CN. Results of this protocol will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinopathy
Keywords
elastic tape, kinesiology taping, physiotherapy, rotator cuff, shoulder pain, tendon injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation program and kinesiotaping.
Arm Type
Experimental
Arm Description
Each patient will attend 10 physiotherapy sessions over six. Patients from the Experimental group (KT group) will receive the same standardized rehabilitation program as control group (No-KT group) including manual therapy, movement training, stretching, muscular strengthening, and patient education. Only KT-group (experimental) will receive therapeutic KT added to the rehabilitation program. Kinesio® Tex Classic will be applied using a combination of techniques designed for RCTe and underlying symptoms following the instructions and principles described by Kase et al (2003). Kinesiotaping strips will be weaned gradually, according to the individual improvements of deficits evaluated weekly by the physiotherapist treating.
Arm Title
Rehabilitation program.
Arm Type
Active Comparator
Arm Description
Each patient will attend 10 physiotherapy sessions over six. Patients allocated at the control group (No-KT group) will receive only the rehabilitation program, including manual therapy, movement training, stretching, muscular strengthening, and patient education. The rehabilitation program will be exactly the same applied to the experimental group (KT group).
Intervention Type
Other
Intervention Name(s)
Rehabilitation program
Intervention Description
Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.
Intervention Type
Device
Intervention Name(s)
Kinesiotaping
Other Intervention Name(s)
Kinesio Tex Classic, Elastic tape, bandage, taping, Kinesio Tape, Kinesiology tape, Kinesiotape
Intervention Description
Combined Kinesiotaping techniques (3 strips) for rotator cuff tendinopathy, following the principles of Kenzo Kase et al. (2003).
Primary Outcome Measure Information:
Title
Functional Limitations (changes during treatment; from baseline to 6 months follow-up).
Description
Functional limitations will be measured throughout treatment using "The Disabilities of the Arm, Shoulder, and Hand (DASH)". The DASH is a 30-item self-report questionnaire, designed to measure physical disability and symptoms of upper limbs disorders. A validated Canadian-French version will be used (Intraclass correlation coefficient (ICC)=0.93; standardized response mean (SRM)=1.35; minimal detectable change (MDC)=11.4 points; clinically important difference (CID)=10 points)
Time Frame
Week-0 (baseline), week-3 (mid-point of the treatment), week-6 (end of treatment), week-12 (mid-term follow-up), 6-month (long-term follow-up).
Title
Symptoms (pain intensity; changes during treatment; from baseline to 6 months follow-up).
Description
Since DASH has few questions related to pain, the Brief Pain Inventory (BPI), which is specific for assessing clinical pain, will also be added to assess changes during treatment. The BPI measures pain intensity on an 11-point numerical rating scale (0-10), according to it interference with sleep, mood, etc., during the last 24 hours (ICC >0.80). Only the 4 first questions, related to clinical pain, will be used.
Time Frame
Week-0 (baseline), week-3 (mid-point of the treatment), week-6 (end of treatment), week-12 (mid-term follow-up), 6-month (long-term follow-up).
Title
Symptoms (shoulder disabilities; changes during treatment; from baseline to 6 months follow-up).
Description
Because DASH is non-specific for shoulder, the "Western Ontario Rotator Cuff (WORC)" index will be added to assess changes at shoulder disabilities throughout treatment. The WORC is a reliable and responsive (ICC=0.96; SRM=1.54; MDC=12 points; CID=13 points) questionnaire designed to measure health-related-quality-of-life of patients affected by RC injuries.
Time Frame
Week-0 (baseline), week-3 (mid-point of the treatment), week-6 (end of treatment), week-12 (mid-term follow-up), 6-month (long-term follow-up).
Secondary Outcome Measure Information:
Title
Range of Motion
Description
Active full and pain free range of motion in shoulder elevation in the frontal (abduction) and sagittal (flexion) planes will be measured using a digital inclinometer.
Time Frame
Week-0 (baseline), week-6 (end of treatment).
Title
Acromiohumeral distance
Description
Outcome measurements at rest and 60º of active abduction using an ultrasound scanner.
Time Frame
Week-0 (baseline), week-6 (end of treatment).
Title
Maximal electromyographic (EMG) amplitude
Description
Maximal EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.
Time Frame
Week-0 (baseline), week-6 (end of treatment).
Title
Mean peak EMG amplitude
Description
Mean peak EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.
Time Frame
Week-0 (baseline), week-6 (end of treatment).
Title
Onset timing
Description
Measurements at scaption (functional movement) using a slapping-ball task.
Time Frame
Week-0 (baseline), week-6 (end of treatment).
Other Pre-specified Outcome Measures:
Title
Global Rating of Change
Description
Participants will be asked to evaluate the change in their condition since the first physiotherapy session.
Time Frame
Week-6 (end of treatment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria. To be eligible, participants should have unilateral rotator cuff tendinopathy and to present one positive finding in each of the following categories: Painful arc of movement during flexion or abduction; Neer (sensitivity 0.78, specificity 0.58) or Kennedy-Hawkins impingement signs (sensitivity 0.74, specificity 0.57); Pain on resisted external rotation, abduction or empty can test (sensitivity 0.69, specificity 0.62). Exclusion Criteria. Patients will be excluded if they have: an open wound that compromises KT application; had a previous shoulder surgery; allergy or intolerance to KT; adhesive capsulitis, defined as loss of passive shoulder ROM greater than 50%; history of glenohumeral luxation or fracture to the shoulder girdle; shoulder pain reproduced by cervical movements; clinical signs of full-thickness RC tears identified by lag signs tests (drop, internal, and external rotation signs).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien Roy, PT, PhD
Organizational Affiliation
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fábio C L de Oliveira, PT, MSc
Organizational Affiliation
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Interdisciplinary Research in Rehabilitation and Social Integration Research (CIRRIS)
City
Québec city
State/Province
Quebec
ZIP/Postal Code
G1M2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32986531
Citation
de Oliveira FCL, Pairot de Fontenay B, Bouyer LJ, Desmeules F, Roy JS. Kinesiotaping for the Rehabilitation of Rotator Cuff-Related Shoulder Pain: A Randomized Clinical Trial. Sports Health. 2021 Mar;13(2):161-172. doi: 10.1177/1941738120944254. Epub 2020 Sep 28.
Results Reference
derived
PubMed Identifier
28947462
Citation
de Oliveira FCL, Pairot de Fontenay B, Bouyer LJ, Desmeules F, Roy JS. Effects of kinesiotaping added to a rehabilitation programme for patients with rotator cuff tendinopathy: protocol for a single-blind, randomised controlled trial addressing symptoms, functional limitations and underlying deficits. BMJ Open. 2017 Sep 24;7(9):e017951. doi: 10.1136/bmjopen-2017-017951.
Results Reference
derived

Learn more about this trial

Effects of Kinesiotaping on Symptoms, Functional Limitations, and Underlying Deficits of Patients With Rotator Cuff Tendinopathy

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