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

Rotator Cuff Tendinopathy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881021
• Other study ID #: FOliveira
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: April 27, 2018

Study information

• Verified date: February 2019
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 27, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Rotator Cuff Tendinopathy
• Tendinopathy

Intervention

Other:
• Rehabilitation program
Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.

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

Locations

Country	Name	City	State
Canada	Center for Interdisciplinary Research in Rehabilitation and Social Integration Research (CIRRIS)	Québec city	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Rating of Change	Participants will be asked to evaluate the change in their condition since the first physiotherapy session.	Week-6 (end of treatment).
Primary	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)	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).
Primary	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.	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).
Primary	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.	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	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.	Week-0 (baseline), week-6 (end of treatment).
Secondary	Acromiohumeral distance	Outcome measurements at rest and 60º of active abduction using an ultrasound scanner.	Week-0 (baseline), week-6 (end of treatment).
Secondary	Maximal electromyographic (EMG) amplitude	Maximal EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.	Week-0 (baseline), week-6 (end of treatment).
Secondary	Mean peak EMG amplitude	Mean peak EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.	Week-0 (baseline), week-6 (end of treatment).
Secondary	Onset timing	Measurements at scaption (functional movement) using a slapping-ball task.	Week-0 (baseline), week-6 (end of treatment).