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

NCT ID: NCT02881021

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-04-27

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.

Conditions

Rotator Cuff Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitation program and kinesiotaping.

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.

Group Type: EXPERIMENTAL

Rehabilitation program

Intervention Type: OTHER

Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.

Kinesiotaping

Intervention Type: DEVICE

Combined Kinesiotaping techniques (3 strips) for rotator cuff tendinopathy, following the principles of Kenzo Kase et al. (2003).

Rehabilitation program.

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).

Group Type: ACTIVE_COMPARATOR

Rehabilitation program

Intervention Type: OTHER

Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.

Interventions

Rehabilitation program

Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.

Intervention Type: OTHER

Kinesiotaping

Combined Kinesiotaping techniques (3 strips) for rotator cuff tendinopathy, following the principles of Kenzo Kase et al. (2003).

Intervention Type: DEVICE

Other Intervention Names

Kinesio Tex Classic; Elastic tape; bandage; taping; Kinesio Tape; Kinesiology tape; Kinesiotape

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Fabio Oliveira

PT, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Sébastien Roy, PT, PhD

Role: STUDY_DIRECTOR

Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN

Fábio C L de Oliveira, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN

Locations

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

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32986531 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28947462 (View on PubMed)

Other Identifiers

FOliveira

Identifier Type: -

Identifier Source: org_study_id