NCT06010264

Brief Summary

The goal of this clinical trial is to the effects of kinesio tape application on pain, edema, range of motion and functionality . The main questions it aims to answer are:

  • Does kinesiotape application reduce pain and edema and improve quality of life in the early period in individuals undergoing arthroscopic rotator cuff repair?
  • Does kinesiotape application provide early restoration of functional activity level in individuals undergoing arthroscopic rotator cuff repair? Participants will receive kinesiotaping in addition to traditional physiotherapy programs. If there is a comparison group: Researchers will compare kinesiotape group, shamtape group and control group to see if kinesiotaping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 10, 2023

Last Update Submit

August 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain severity

    Visual Analogue Scale (0-10, higher means worse)

    7 weeks

  • Edema

    Diameter measurement was performed to evaluate the level of edema in the shoulder joint. Two reference points, the posterosuperior end of the acromion and the korkoid process, were used to measure the diameter of the shoulder. First, the distance between these points on the upper border of the deltoid muscle was measured with a tape measure and recorded. The second measurement was taken 1 cm lateral to the first measurement, over the middle deltoid and recorded.

    7 weeks

Secondary Outcomes (4)

  • Modified Constant-Murley score

    7 weeks

  • REVISED OXFORD SHOULDER SCORE

    7 weeks

  • SHOULDER PAIN AND DISABILITY INDEX

    7 weeks

  • Western Ontario Rotator Cuff Index

    7 weeks

Study Arms (3)

Kinesiotaping group

EXPERIMENTAL

Kinesiotaping + Standard Physiotherapy Program

Other: Kinesiotape

Control group

ACTIVE COMPARATOR

Standard Physiotherapy Program

Other: Standard Physiotherapy Program

Shamtape Group

SHAM COMPARATOR

Shamtaping + Standard Physiotherapy Program

Other: Shamtape

Interventions

In the kinesiotaping group, kinesiotape was applied from the first postoperative day in addition to conservative treatment. Kinesiobant application was performed regularly until the 6th week by a researcher with a certificate in kinesiobanting in accordance with the lymphatic correction and pain inhibition techniques described by Kenzo Kase. Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain

Kinesiotaping group

In the sham taping group, sham tape was applied from the first postoperative day in addition to conservative treatment. Medical flasters were used as sham tape. Sham tapes were applied by cutting in the same fan shape as in kinesioband. Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain

Shamtape Group

Conservative Treatment Program. 1-10 days: Patient education Pendulum exercises Active hand and wrist exercises Cold Application 1-6 Weeks: Pendulum exercises are continued Active hand and wrist exercises are continued Cold application is continued Passive arm elevation with opposite hand support in supine position Elbow flexion/extension exercise at the limit of pain

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between the ages of 18-65,
  • Arthroscopic rotator cuff repair as a surgical method,
  • diagnosis of a small or medium-sized (\<3 cm) rotator cuff tear by magnetic resonance imaging,
  • Having a score above 24 on the Mini Mental State Examination,
  • Volunteering to participate in the study.

You may not qualify if:

  • Presence of diabetes mellitus,
  • Stage three and above according to the Goutallier fatty degeneration classification,
  • Presence of a neurological problem,
  • Presence of cervical disc herniation,
  • Past history of orthopedic disease on the affected side,
  • Presence of osteoarthritis, rheumatoid arthritis or other systemic inflammatory problem,
  • Corticosteroid injection for the affected side within 6 weeks before diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırsehir Ahi Evran Universty

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • Gulenc B, Yalcin S, Genc SG, Bicer H, Erdil M. Is Kinesiotherapy Effective in Relieving Pain and Reducing Swelling after Shoulder Arthroscopy? Acta Chir Orthop Traumatol Cech. 2019;86(3):216-219.

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD / LECTURER

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 24, 2023

Study Start

July 6, 2022

Primary Completion

December 29, 2022

Study Completion

January 1, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations