Clinical trial NCT02881021: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendinopathy
Keywords: elastic tape
kinesiology taping
physiotherapy
rotator cuff
shoulder pain
tendon injuries
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-08-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Functional Limitations (changes during treatment; from baseline to 6 months follow-up).
timeFrame: 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).
measure: Symptoms (pain intensity; changes during treatment; from baseline to 6 months follow-up).
timeFrame: 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).
measure: Symptoms (shoulder disabilities; changes during treatment; from baseline to 6 months follow-up).
timeFrame: 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 outcomes:
measure: Range of Motion
timeFrame: Week-0 (baseline), week-6 (end of treatment).
measure: Acromiohumeral distance
timeFrame: Week-0 (baseline), week-6 (end of treatment).
measure: Maximal electromyographic (EMG) amplitude
timeFrame: Week-0 (baseline), week-6 (end of treatment).
measure: Mean peak EMG amplitude
timeFrame: Week-0 (baseline), week-6 (end of treatment).
measure: Onset timing
timeFrame: Week-0 (baseline), week-6 (end of treatment).
Other outcomes:
measure: Global Rating of Change
timeFrame: Week-6 (end of treatment).
Locations:
city: Québec city
country: Canada
facility: Center for Interdisciplinary Research in Rehabilitation and Social Integration Research (CIRRIS)
state: Quebec
Study officials:
affiliation: Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
name: Jean-Sébastien Roy, PT, PhD
role: STUDY_DIRECTOR
affiliation: Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
name: Fábio C L de Oliveira, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.