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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Laval University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Functional Limitations (changes during treatment; from baseline to 6 months follow-up).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Rehabilitation program (Other)
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.
Intervention: Kinesiotaping (Device)
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).
Intervention: Rehabilitation program (Other)
Outcomes
Primary Outcomes
Functional Limitations (changes during treatment; from baseline to 6 months follow-up).
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).
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).
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).
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).
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).
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 Outcomes
- Range of Motion(Week-0 (baseline), week-6 (end of treatment).)
- Acromiohumeral distance(Week-0 (baseline), week-6 (end of treatment).)
- Maximal electromyographic (EMG) amplitude(Week-0 (baseline), week-6 (end of treatment).)
- Mean peak EMG amplitude(Week-0 (baseline), week-6 (end of treatment).)
- Onset timing(Week-0 (baseline), week-6 (end of treatment).)
Investigators
Fabio Oliveira
PT, MSc
Laval University