search
Back to results

THE EFFECTS OF EARLY PERIOD KINESIOTAPE

Primary Purpose

Rotator Cuff Injuries, Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotape
Shamtape
Standard Physiotherapy Program
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Kırsehir Ahi Evran Universty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Kinesiotaping group

Control group

Shamtape Group

Arm Description

Kinesiotaping + Standard Physiotherapy Program

Standard Physiotherapy Program

Shamtaping + Standard Physiotherapy Program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Modified Constant-Murley score
The Modified Constant-Murley score is a 100-point scoring system that is divided into 4 subscales: pain, 15 points; activities of daily living (ADL), 20; range of motion (ROM), 40; and strength, 25. The pain and ADL subscales are self-reported by the patient. In the original version, the pain score was graded as none = 15, mild = 10, moderate = 5, and severe = 0.
REVISED OXFORD SHOULDER SCORE
REVISED OXFORD SHOULDER SCORE was developed to evaluate the functional parameters of the shoulder after surgery. It consists of a total of 12 questions. Each question has 5 answers ranging from 0 (bad score) to 4 (good score). The total score ranges from 0 to 48. 0 indicates the worst result, while the higher the score, the better the functionality. A score between 0-19 indicates severe disability, 20-29 indicates moderate disability, 30-39 indicates mild disability. A score between 40-48 indicates adequate functionality.
SHOULDER PAIN AND DISABILITY INDEX
The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.
Western Ontario Rotator Cuff Index
WORC consists of 5 sections with 21 questions. The answer to each question is given on the VAS. The final score is between 0 and 2100. The higher the score, the lower the quality of life.

Full Information

First Posted
August 10, 2023
Last Updated
August 17, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
search

1. Study Identification

Unique Protocol Identification Number
NCT06010264
Brief Title
THE EFFECTS OF EARLY PERIOD KINESIOTAPE
Official Title
THE EFFECTS OF EARLY PERIOD KINESIO TAPE ON CLINICAL OUTCOMES IN PATIENTS WITH ARTROSCOPIC ROTATOR CUFF REPAIR
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Chronic shoulder pain is the second most common musculoskeletal problem in the population with a prevalence ranging from 15% to 22%. Rotator cuff (RM) tears are one of the important pathophysiologic conditions leading to shoulder pain. Early treatment of RM tears is conservative and includes oral analgesics, non-steroidal anti-inflammatory drugs, corticosteroid injections if necessary and physiotherapy methods. Treatment of rotator sheath problems may be surgical and/or conservative depending on the indications. Surgical treatment is inevitable for partial tears and complete ruptures that do not respond to conservative treatment. After surgery, a good rehabilitation program is needed to increase the success of the surgical intervention, return to functional activities and improve the patient's quality of life. One of the most important problems for the patient, physician and physiotherapist in the rehabilitation program to be applied in this period is the immobilization period of 6 weeks. This is the recommended time for tissue healing. However, the negative effects of prolonged immobilization should not be forgotten. It is important to use early physiotherapy applications to prevent adhesions and reduce complications that may occur. The Kinesio Taping® technique and Kinesio Tex® tape were developed in 1973 by Dr. Kenzo Kase, a Japanese chiropractor and acupuncturist. There is an increasing number of health professionals, including physicians and physiotherapists who deal with musculoskeletal diseases and lymphology, who apply this method to their patients all over the world. It is also widely used in the sports world, especially considering its ease of use and effects. It helps structures such as the musculoskeletal system, circulatory system and nervous system to return to normal function. It is a preferred method because these bands are easy to apply and patients can easily remove them. In the literature, there is no study examining the effects of kinesio tape application after rotator cuff repair. Considering the effects of kinesio tape on pain and edema; we think that it will have positive results in the rehabilitation program applied after rotator cuff repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotaping group
Arm Type
Experimental
Arm Description
Kinesiotaping + Standard Physiotherapy Program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard Physiotherapy Program
Arm Title
Shamtape Group
Arm Type
Sham Comparator
Arm Description
Shamtaping + Standard Physiotherapy Program
Intervention Type
Other
Intervention Name(s)
Kinesiotape
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Shamtape
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain severity
Description
Visual Analogue Scale (0-10, higher means worse)
Time Frame
7 weeks
Title
Edema
Description
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.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Modified Constant-Murley score
Description
The Modified Constant-Murley score is a 100-point scoring system that is divided into 4 subscales: pain, 15 points; activities of daily living (ADL), 20; range of motion (ROM), 40; and strength, 25. The pain and ADL subscales are self-reported by the patient. In the original version, the pain score was graded as none = 15, mild = 10, moderate = 5, and severe = 0.
Time Frame
7 weeks
Title
REVISED OXFORD SHOULDER SCORE
Description
REVISED OXFORD SHOULDER SCORE was developed to evaluate the functional parameters of the shoulder after surgery. It consists of a total of 12 questions. Each question has 5 answers ranging from 0 (bad score) to 4 (good score). The total score ranges from 0 to 48. 0 indicates the worst result, while the higher the score, the better the functionality. A score between 0-19 indicates severe disability, 20-29 indicates moderate disability, 30-39 indicates mild disability. A score between 40-48 indicates adequate functionality.
Time Frame
7 weeks
Title
SHOULDER PAIN AND DISABILITY INDEX
Description
The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.
Time Frame
7 weeks
Title
Western Ontario Rotator Cuff Index
Description
WORC consists of 5 sections with 21 questions. The answer to each question is given on the VAS. The final score is between 0 and 2100. The higher the score, the lower the quality of life.
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Kırsehir Ahi Evran Universty
City
Kırşehir
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30134883
Citation
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.
Results Reference
result
PubMed Identifier
31333187
Citation
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.
Results Reference
result

Learn more about this trial

THE EFFECTS OF EARLY PERIOD KINESIOTAPE

We'll reach out to this number within 24 hrs