Effects of Kinesiotaping on Muscular Activity, Mobility, Strength and Pain After Rotator Cuff Surgery

NCT03379636 | Completed DMC

• 1 other identifier: CliniqueRR-006
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Rotator Cuff Tear

Keywords

Athletic tape; Electromyography; Rehabilitation; Shoulder

Outcome Measures

Primary Outcomes (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

  6 and 12 weeks post surgery

Secondary Outcomes (3)

• active range of motion

  6 and 12 weeks post surgery

• strength

  6 and 12 weeks post surgery

• pain

  6 and 12 weeks post surgery

Study Arms (3)

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

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

Device: sham tape

Interventions

kinesiotape DEVICE

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

kinesiotape

sham tape DEVICE

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.

sham tape

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult subject who had a surgery less than 6 weeks ago after a shoulder rotator cuff tear

You may not qualify if:

• re-tear of the rotator cuff, associated neurological lesion, concomitant cervical or elbow lesion

Sponsors & Collaborators

• Clinique Romande de Readaptation: lead

Related Publications (2)

• Kase K, Wallis J, Kase T: Clinical Therapeutic Applications of the Kinesio Taping Method. Tokyo, Japan: Keni-Kai information; 2003.

  BACKGROUND

• 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.

  PMID: 30134883 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Bertrand Léger, PhD

  Clinique romande de réadaptation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The physiotherapist who applied the tape was not blinded but he did not participate in outcome assessment. The main investigator 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: January 7, 2013
• Primary Completion: January 4, 2017
• Study Completion: January 4, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12