Rotator Cuff TendinopathyNCT02881021
Effects of Kinesiotaping on Symptoms, Functional Limitations, and Underlying Deficits of Patients With Rotator Cuff Tendinopathy
A study testing Rehabilitation program and Kinesiotaping in people with Rotator Cuff Tendinopathy, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Rehabilitation program and Kinesiotaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2016to 27 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Center for Interdisciplinary Research in Rehabilitation and Social Integration Research (CIRRIS)
Québec, Quebec, G1M2S8
About this study
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.
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.
Read more
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
- Being tested
- Rehabilitation program, Kinesiotaping
- Keywords
- elastic tape, kinesiology taping, physiotherapy, rotator cuff, shoulder pain, tendon injuries
- Medical subject headings
- Shoulder Pain, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.
KinesiotapingDevice
Also called Kinesio Tex Classic, Elastic tape, bandage, taping
Combined Kinesiotaping techniques (3 strips) for rotator cuff tendinopathy, following the principles of Kenzo Kase et al. (2003).
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation program and kinesiotaping. | Experimental | 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. Receives: Other: Rehabilitation program; Device: Kinesiotaping |
| Rehabilitation program. | Active comparator | 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). Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
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.
Measured: 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).
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.
Measured: 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 (5)
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.
Measured: Week-0 (baseline), week-6 (end of treatment).
Acromiohumeral distance
Outcome measurements at rest and 60º of active abduction using an ultrasound scanner.
Measured: Week-0 (baseline), week-6 (end of treatment).
Maximal electromyographic (EMG) amplitude
Maximal EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.
Measured: Week-0 (baseline), week-6 (end of treatment).
Mean peak EMG amplitude
Mean peak EMG amplitude of infraspinatus, anterior and middle deltoid during full-range shoulder flexion and abduction.
Measured: Week-0 (baseline), week-6 (end of treatment).
Onset timing
Measurements at scaption (functional movement) using a slapping-ball task.
Measured: Week-0 (baseline), week-6 (end of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start1 Sep 2016
- Primary completion30 Nov 2017
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Fabio Oliveira, Laval University
- Investigators
- Jean-Sébastien Roy, PT, PhD, Study director, Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CNFábio C L de Oliveira, PT, MSc, Principal investigator, Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881021
- Sponsor's protocol ID
- FOliveira
- Status last verified
- Feb 2019
- First submitted
- 12 Aug 2016
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32986531de 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.
PubMed 28947462
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02881021
- Acronym / sponsor ID
- FOliveira
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- elastic tape, kinesiology taping, physiotherapy, rotator cuff, shoulder pain, tendon injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation program and kinesiotaping. | Experimental | Other: Rehabilitation program, Device: KinesiotapingEach 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. |
| Rehabilitation program. | Active comparator | Other: Rehabilitation programEach 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation programStandardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy. | Other | Rehabilitation program and kinesiotaping., Rehabilitation program. |
| KinesiotapingAlso: Kinesio Tex Classic, Elastic tape, bandage, tapingCombined Kinesiotaping techniques (3 strips) for rotator cuff tendinopathy, following the principles of Kenzo Kase et al. (2003). | Device | Rehabilitation program and kinesiotaping. |
Primary outcome
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.
5 secondary outcomes
Range of Motion
Time frame: Week-0 (baseline), week-6 (end of treatment).
Acromiohumeral distance
Time frame: Week-0 (baseline), week-6 (end of treatment).
Maximal electromyographic (EMG) amplitude
Time frame: Week-0 (baseline), week-6 (end of treatment).
Mean peak EMG amplitude
Time frame: Week-0 (baseline), week-6 (end of treatment).
Onset timing
Time frame: Week-0 (baseline), week-6 (end of treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 32986531de 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.
- Derived from this study: PubMed 28947462de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD study director
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
Fábio C L de Oliveira, PT, MSc principal investigator
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS), CIUSSS-CN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program and Kinesiotaping in people with Rotator Cuff Tendinopathy, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881021, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.