Rotator Cuff TearNCT03379636
Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery
A study testing kinesiotape in people with Rotator Cuff Tear, run by Clinique Romande de Readaptation.
Trial summary
Kinesiotape (KT) is widely used in musculoskeletal rehabilitation as an adjuvant to treatment but minimal evidence supports its use. The aim of this study is to determine the immediate and short-term effects of shoulder KT on muscular activity, mobility, strength and pain after rotator cuff surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- kinesiotape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2013to 4 Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult subject who had a surgery less than 6 weeks ago after a shoulder rotator cuff tear
Who cannot join
- re-tear of the rotator cuff, associated neurological lesion, concomitant cervical or elbow lesion
About this study
Official title: Immediate and Short-term Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery: A Cross-over Clinical Trial
Kinesiotape (KT) is widely used in musculoskeletal rehabilitation as an adjuvant to treatment but minimal evidence supports its use. The aim of this study is to determine the immediate and short-term effects of shoulder KT on muscular activity, mobility, strength and pain after rotator cuff surgery. Our hypotheses were that KT should not improve muscle function, mobility, strength or pain in a clinically meaningful way.
Methods: Thirty-nine subjects with shoulder rotator cuff surgery were tested 6 and 12 weeks post-surgery, without tape, with KT and with a sham tape (ST). KT and ST were applied in a randomized order. For each condition, muscular activity of upper trapezius, three parts of deltoid and infraspinatus during shoulder flexion, range of motion (ROM) and pain intensity were assessed. At 12 weeks, isometric strength at 90° of shoulder flexion, with related muscular activity and pain intensity were also measured. Subjects maintained the last tape applied for three days and recorded pain intensity at wake-up and during the day.
Read the detailed description
Sample size was calculated a priori using STATA Version 13.1 software (StataCorp, College Station, USA). Based on data of muscular activity from the article of Hsu et al 20 and considering a statistical power of 80% and a Type I error of .05, a need for at least 36 subjects was necessary to highlight a group difference. We finally enrolled 39 subjects between January 2013 and October 2016. Informed written consent was obtained from all subjects and all rights of the participants were protected.
Testing procedure:
Subjects were invited to come at the Clinique romande de réadaptation in Sion (Switzerland) on two occasions: 6 and 12 weeks after their surgery. Each time, they first filled the French version of the quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in order to assess their physical function and symptoms. This 11-item questionnaire is valid, reliable and responsive in shoulder disorders.14, 17 They also estimated their pain intensity at rest using a 100-mm visual analogue scale (VAS).
A baseline measurement was then realized, without any tape (NT). The subjects were seated on a chair without resting on the backrest, the arms along the body. Shoulder rotation was neutral, elbow extended and forearm in neutral position. The subjects had to lift their arm in the sagittal plane as high as possible, hold the position for 5 seconds and then return at initial position. The movement was repeated once after one minute rest.
During the second session, at 12 weeks, the subjects realized in addition a maximal voluntary isometric contraction measure (MVIC). The measure was realized at 90° of shoulder flexion, neutral rotation, elbow extended, pronation of the forearm and fist closed. The strap of the dynamometer was applied at the level of the wrist.5 The subjects had to develop the maximal force during a 5-seconds period. After one minute rest, a second trial took place. The whole session was videotaped for further analysis. At the end of the testing sessions, the subjects were instructed not to remove the last tape applied for 72 hours.
The sequence always began with the NT condition. Then the two tapes were applied in a randomized order and the subjects repeated the same procedure. Group allocation, KT vs ST group, corresponded to the last tape the subject received and had to wear for the next three days. A computer block (n=8) randomization process was performed and sealed opaque envelopes were used. The physiotherapist who applied the tape was not blinded but he did not participate in outcome assessment. The main investigator (first author) who collected the data was blind as subjects wore a long-sleeve shirt which hid the tape and the tape was administered behind a folding screen.
Statistical analysis:
Comparisons between baseline characteristics of the two groups were computed using nonparametric tests comparing the medians for continuous variables or chi-squared tests for categorical variables.
The outcome variables measured during the mobility and the strength tests were compared between the three taping conditions. For the VAS outcomes during the three days after tape application, comparisons were realized between KT and ST solely. As the distributions of the outcome variables were not normal, nonparametric tests comparing the medians were performed. All analyses were done using Stata 13.1 software.
As multiple comparisons were realized, the level of statistical significance was set at P<.017 (.05/3) for the comparisons between the three conditions of tape (comparison of NT vs KT, NT vs ST, KT vs ST). For comparison between KT group and ST group only, the level of significance was set at P<.05.
- Conditions
- Rotator Cuff Tear
- Being tested
- kinesiotape, sham tape
- Keywords
- Athletic tape, Electromyography, Rehabilitation, Shoulder
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapeDevice
Application of an elastic beige 5-cm width Leukotape®K (BSN medical, Germany). The first strip, a Y-strip, was applied with 10% to 15% of tension over the deltoid muscle, from origin to insertion with the first tail along the anterior deltoid while the arm was externally rotated and horizontally abducted. The second tail was applied along the posterior deltoid with the arm horizontally adducted and internally rotated. A second strip, an I-strip, was applied for mechanical correction, transversally in the sagittal plane over the acromioclavicular joint with a downward pressure applied to the KT, the arm being at trunk side
sham tapeDevice
a rigid Leukotape®Classic (BSN medical, Germany) was used. A 5-cm strip was applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area.
| Study group | Role | What they receive |
|---|---|---|
| no tape | No intervention | tests are realised without any shoulder tape |
| kinesiotape | Experimental | tests are realised with a kinesiotape applied according to Dr Kase model, over the deltoid muscle and over the acromioclavicular joint Receives: Device: kinesiotape |
| sham tape | Sham comparator | tests are realised with a sham tape, applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area Receives: Device: sham tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscular activity
Activity of upper trapezius, anterior, middle and posterior parts of deltoid ans of infraspinatus.
The mean amplitude of electromyographic (EMG) signal, expressed as a percentage of reference voluntary contraction (RVC) is used
Measured: 6 and 12 weeks post surgery
Secondary outcomes (3)
active range of motion
shoulder flexion measured in degrees
Measured: 6 and 12 weeks post surgery
strength
isometric strength at 90° of shoulder flexion, measured in kg
Measured: 6 and 12 weeks post surgery
pain
shoulder pain intensity measured with a 100-mm visual analog scale (0: no pain; 100: worst imaginable pain). Shoulder pain intensity was assessed at end-point of ROM and after isometric force assessment. This measure is known for its excellent reliability.
Measured: 6 and 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start7 Jan 2013
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
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 TearStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- All subjects were tested without tape, with kinesiotape (KT) and with a sham tape (ST). KT and ST were applied in a randomized order. The sequence always began with the NT condition. Then the two tapes were applied in a randomized order and the subjects repeated the same procedure. Group allocation, KT vs ST group, corresponded to the last tape the subject received and had to wear for the next three days. A computer block (n=8) randomization process was performed and sealed opaque envelopes were used.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Bertrand Léger, PhD, Study chair, Clinique romande de réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379636
- Sponsor's protocol ID
- CliniqueRR-006
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kase K, Wallis J, Kase T: Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Keni-Kai information; 2003.
Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.
PubMed 30134883
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Short-term Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery: A Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT03379636
- Acronym / sponsor ID
- CliniqueRR-006
- Conditions
- Rotator Cuff Tear
- Keywords
- Athletic tape, Electromyography, Rehabilitation, Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 20 Dec 2017 (actual)
- 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.
Kinesiotape (KT) is widely used in musculoskeletal rehabilitation as an adjuvant to treatment but minimal evidence supports its use. The aim of this study is to determine the immediate and short-term effects of shoulder KT on muscular activity, mobility, strength and pain after rotator cuff surgery. Our hypotheses were that KT should not improve muscle function, mobility, strength or pain in a clinically meaningful way.
Methods: Thirty-nine subjects with shoulder rotator cuff surgery were tested 6 and 12 weeks post-surgery, without tape, with KT and with a sham tape (ST). KT and ST were applied in a randomized order. For each condition, muscular activity of upper trapezius, three parts of deltoid and infraspinatus during shoulder flexion, range of motion (ROM) and pain intensity were assessed. At 12 weeks, isometric strength at 90° of shoulder flexion, with related muscular activity and pain intensity were also measured. Subjects maintained the last tape applied for three days and recorded pain intensity at wake-up and during the day.
Detailed description
Sample size was calculated a priori using STATA Version 13.1 software (StataCorp, College Station, USA). Based on data of muscular activity from the article of Hsu et al 20 and considering a statistical power of 80% and a Type I error of .05, a need for at least 36 subjects was necessary to highlight a group difference. We finally enrolled 39 subjects between January 2013 and October 2016. Informed written consent was obtained from all subjects and all rights of the participants were protected.
Testing procedure:
Subjects were invited to come at the Clinique romande de réadaptation in Sion (Switzerland) on two occasions: 6 and 12 weeks after their surgery. Each time, they first filled the French version of the quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in order to assess their physical function and symptoms. This 11-item questionnaire is valid, reliable and responsive in shoulder disorders.14, 17 They also estimated their pain intensity at rest using a 100-mm visual analogue scale (VAS).
A baseline measurement was then realized, without any tape (NT). The subjects were seated on a chair without resting on the backrest, the arms along the body. Shoulder rotation was neutral, elbow extended and forearm in neutral position. The subjects had to lift their arm in the sagittal plane as high as possible, hold the position for 5 seconds and then return at initial position. The movement was repeated once after one minute rest.
During the second session, at 12 weeks, the subjects realized in addition a maximal voluntary isometric contraction measure (MVIC). The measure was realized at 90° of shoulder flexion, neutral rotation, elbow extended, pronation of the forearm and fist closed. The strap of the dynamometer was applied at the level of the wrist.5 The subjects had to develop the maximal force during a 5-seconds period. After one minute rest, a second trial took place. The whole session was videotaped for further analysis. At the end of the testing sessions, the subjects were instructed not to remove the last tape applied for 72 hours.
The sequence always began with the NT condition. Then the two tapes were applied in a randomized order and the subjects repeated the same procedure. Group allocation, KT vs ST group, corresponded to the last tape the subject received and had to wear for the next three days. A computer block (n=8) randomization process was performed and sealed opaque envelopes were used. The physiotherapist who applied the tape was not blinded but he did not participate in outcome assessment. The main investigator (first author) who collected the data was blind as subjects wore a long-sleeve shirt which hid the tape and the tape was administered behind a folding screen.
Statistical analysis:
Comparisons between baseline characteristics of the two groups were computed using nonparametric tests comparing the medians for continuous variables or chi-squared tests for categorical variables.
The outcome variables measured during the mobility and the strength tests were compared between the three taping conditions. For the VAS outcomes during the three days after tape application, comparisons were realized between KT and ST solely. As the distributions of the outcome variables were not normal, nonparametric tests comparing the medians were performed. All analyses were done using Stata 13.1 software.
As multiple comparisons were realized, the level of statistical significance was set at P<.017 (.05/3) for the comparisons between the three conditions of tape (comparison of NT vs KT, NT vs ST, KT vs ST). For comparison between KT group and ST group only, the level of significance was set at P<.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All subjects were tested without tape, with kinesiotape (KT) and with a sham tape (ST). KT and ST were applied in a randomized order. The sequence always began with the NT condition. Then the two tapes were applied in a randomized order and the subjects repeated the same procedure. Group allocation, KT vs ST group, corresponded to the last tape the subject received and had to wear for the next three days. A computer block (n=8) randomization process was performed and sealed opaque envelopes were used.
| Arm | Type | Receives |
|---|---|---|
| no tape | No intervention | –tests are realised without any shoulder tape |
| kinesiotape | Experimental | Device: kinesiotapetests are realised with a kinesiotape applied according to Dr Kase model, over the deltoid muscle and over the acromioclavicular joint |
| sham tape | Sham comparator | Device: sham tapetests are realised with a sham tape, applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult subject who had a surgery less than 6 weeks ago after a shoulder rotator cuff tear
Key exclusion criteria (1 listed)
- re-tear of the rotator cuff, associated neurological lesion, concomitant cervical or elbow lesion
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 |
|---|---|---|
| kinesiotapeApplication of an elastic beige 5-cm width Leukotape®K (BSN medical, Germany). The first strip, a Y-strip, was applied with 10% to 15% of tension over the deltoid muscle, from origin to insertion with the first tail along the anterior deltoid while the arm was externally rotated and horizontally abducted. The second tail was applied along the posterior deltoid with the arm horizontally adducted and internally rotated. A second strip, an I-strip, was applied for mechanical correction, transversally in the sagittal plane over the acromioclavicular joint with a downward pressure applied to the KT, the arm being at trunk side | Device | kinesiotape |
| sham tapea rigid Leukotape®Classic (BSN medical, Germany) was used. A 5-cm strip was applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area. | Device | sham tape |
Primary outcome
muscular activity
Time frame: 6 and 12 weeks post surgery
Activity of upper trapezius, anterior, middle and posterior parts of deltoid ans of infraspinatus. The mean amplitude of electromyographic (EMG) signal, expressed as a percentage of reference voluntary contraction (RVC) is used
3 secondary outcomes
active range of motion
Time frame: 6 and 12 weeks post surgery
strength
Time frame: 6 and 12 weeks post surgery
pain
Time frame: 6 and 12 weeks post surgery
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 22 Dec 2017.
- BackgroundKase K, Wallis J, Kase T: Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Keni-Kai information; 2003.
- Derived from this study: PubMed 30134883Reynard F, Vuistiner P, Leger B, Konzelmann M. Immediate and short-term effects of kinesiotaping on muscular activity, mobility, strength and pain after rotator cuff surgery: a crossover clinical trial. BMC Musculoskelet Disord. 2018 Aug 22;19(1):305. doi: 10.1186/s12891-018-2169-5.
- Individual participant dataSharing planned: Undecided
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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.
Bertrand Léger, PhD study chair
Clinique romande de réadaptation
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotape in people with Rotator Cuff Tear, run by Clinique Romande de Readaptation.
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 1 inclusion and 1 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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
muscular activity (time frame: 6 and 12 weeks post surgery). 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 NCT03379636, 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 22 Dec 2017.