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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT03379636
Study groupRoleWhat they receive
no tapeNo interventiontests are realised without any shoulder tape
kinesiotapeExperimentaltests are realised with a kinesiotape applied according to Dr Kase model, over the deltoid muscle and over the acromioclavicular joint
Receives: Device: kinesiotape
sham tapeSham comparatortests 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.

  1. 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)
  1. active range of motion

    shoulder flexion measured in degrees

    Measured: 6 and 12 weeks post surgery

  2. strength

    isometric strength at 90° of shoulder flexion, measured in kg

    Measured: 6 and 12 weeks post surgery

  3. 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.

  1. First posted20 Dec 2017
  2. Study start7 Jan 2013
  3. Primary completion4 Jan 2017
  4. Study completion4 Jan 2017

Resources

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)
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

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.

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