Rotator Cuff InjuriesNCT06010264
THE EFFECTS OF EARLY PERIOD KINESIOTAPE
A study testing Kinesiotape and Standard Physiotherapy Program in people with Rotator Cuff Injuries and Rotator Cuff Tears, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries, Rotator Cuff Tears
- What is being tested?
- Kinesiotape and Standard Physiotherapy Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2022to 1 Jan 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECTS OF EARLY PERIOD KINESIO TAPE ON CLINICAL OUTCOMES IN PATIENTS WITH ARTROSCOPIC ROTATOR CUFF REPAIR
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.
Read the 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.
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tears
- Being tested
- Kinesiotape, Shamtape, Standard Physiotherapy Program
- 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.
KinesiotapeOther
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
ShamtapeOther
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
Standard Physiotherapy ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping group | Experimental | Kinesiotaping + Standard Physiotherapy Program Receives: Other: Kinesiotape |
| Control group | Active comparator | Standard Physiotherapy Program Receives: Other: Standard Physiotherapy Program |
| Shamtape Group | Sham comparator | Shamtaping + Standard Physiotherapy Program Receives: Other: Shamtape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Visual Analogue Scale (0-10, higher means worse)
Measured: 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.
Measured: 7 weeks
Secondary outcomes (4)
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start6 Jul 2022
- Primary completion29 Dec 2022
- Study completion1 Jan 2023
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 InjuriesStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed İhsan KODAK, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010264
- Sponsor's protocol ID
- 2022-14/123
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 30134883Gulenc 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.
PubMed 31333187
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF EARLY PERIOD KINESIO TAPE ON CLINICAL OUTCOMES IN PATIENTS WITH ARTROSCOPIC ROTATOR CUFF REPAIR
- ClinicalTrials.gov ID
- NCT06010264
- Acronym / sponsor ID
- 2022-14/123
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 24 Aug 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping group | Experimental | Other: KinesiotapeKinesiotaping + Standard Physiotherapy Program |
| Control group | Active comparator | Other: Standard Physiotherapy ProgramStandard Physiotherapy Program |
| Shamtape Group | Sham comparator | Other: ShamtapeShamtaping + Standard Physiotherapy Program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| KinesiotapeIn 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 | Other | Kinesiotaping group |
| ShamtapeIn 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 | Other | Shamtape Group |
| Standard Physiotherapy ProgramConservative 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 | Other | Control group |
Primary outcome
Pain severity
Time frame: 7 weeks
Visual Analogue Scale (0-10, higher means worse)
Edema
Time frame: 7 weeks
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.
4 secondary outcomes
Modified Constant-Murley score
Time frame: 7 weeks
REVISED OXFORD SHOULDER SCORE
Time frame: 7 weeks
SHOULDER PAIN AND DISABILITY INDEX
Time frame: 7 weeks
Western Ontario Rotator Cuff Index
Time frame: 7 weeks
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 24 Aug 2023.
- Results publication: 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.
- Results publication: PubMed 31333187Gulenc 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape and Standard Physiotherapy Program in people with Rotator Cuff Injuries and Rotator Cuff Tears, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pain severity (time frame: 7 weeks). The study lists 2 primary outcomes in all. 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 NCT06010264, 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 24 Aug 2023.