Sports Physical TherapyNCT05331963
Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
A study testing Kinesio Taping in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of functional kinesio taping on subacromial space in athletes with rotator cuff tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2022to 1 Jun 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 35 years
- Both gender
- Athletes participating in volley ball, tennis, badminton and golf.
- Presence of shoulder pain in abduction and external rotation during training for more than three months
- Three out of five positive results for the following: painful arc, pain or weakness with resisted external rotation, abduction, Neer test, Hawkins Kennedy test, empty can test/Jobe test
Who cannot join
- H/O shoulder fractures,
- Instability or dislocation (positive apprehension and relocation tests)
- Frozen shoulder (All stages)
- Recent shoulder surgery for a shoulder injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
To determine the effects of functional kinesio taping on subacromial space in athletes with rotator cuff tendinopathy.
Read the detailed description
Subacromial impingement is a condition among athletes those involved in overhead sports activities such as swimming and volleyball. According to Neer there are two main categories of shoulder impingement, these are structural and functional. Structural: caused by reduction of the subacromial space (SAS) due to bony growth, calcification or soft tissue inflammation whereas functional is caused by or superior migration of the humeral head due to muscular weakness imbalance. In some cases subacromial impingement can be result from a combination of both structural and functional factors.Maintenance of the SAS during arm elevation is thus essential for the prevention of Rotator cuff tendinopathy.
The aim of this randomized controlled trial (RCT) is to evaluate the long-term effects of scapular KT, added to a 6-week rehabilitation program, on the subacromial space at different arm positions in athletes with Rotator cuff tendinopathy. To better understand the underlying mechanisms of KT, our secondary objective addressed the effects of KT on reliving pain-free and full ROM of shoulder joint.
- Conditions
- Sports Physical Therapy
- Being tested
- Kinesio Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
Kinesio tape is designed in a specific way that it mimics the human skin nature. It more or less has the same width as the epidermis layer and can be stretched upto 40% of its resting length.Clinically, kinesio tape (KT) is used both alone and with other physiotherapeutic interventions, mainly for the pain control, to reduce inflammation, and to improve functional activity in patients with shoulder pain
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping with rehabilitation program group | Experimental | Rehabilitation program will be given to this group in addition to Kinesio taping on skin for 72 hour. Receives: Other: Kinesio Taping |
| Rehabilitation plan group | No intervention | The rehabilitation program will be provided individually to all participants (twice weekly during the first 4 weeks, then once weekly) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subacrimial space measurement by Ultrasonography
In order to visualize and measure the subacromial space, the Diagnostic Ultrasound will be used with Aquasonic ultrasound gel as the coupling medium. An ultrasound scanner (Canon aplio i600) with frequency of 1 to 22 MHz curved probe will be used in this study to get images. The probe of US will be placed on the anterior-lateral surface of the acromion process, next to the longitudinal axis of the humeral head, and this is the point likely to view the acromion process and humeral head at the same time. The AHD will then measured from inferior surface of acromion process to the superior surface of the humeral head.The distance is basically from cortical layers of both acromion and humerus bone. The acromio humeral distance will be measured at resting position (0° elevation) of shoulder in millimeters.
Measured: Six weeks
Visual Analogue Scale
This scale consist of 0 to 10 rating in which 0 indicates no pain, and 10 indicates the worst pain.(9) The score of VAS is determined by measuring the distance between the no pain or 0 anchor and to the point where patient draw a mark. A higher score indicates greater pain intensity.
Measured: Six weeks
The Disabilities of Arm, Shoulder and Hand Questionnaire
The DASH will be used to measure functional disorder, physical disability and symptoms of the upper limbs. It consists of 30 questions. 21 questions are related to specific physical tasks in which a person felt difficulty performing last week. 6 questions are to assess specific symptoms including pain, numbness and stiffness. 3 questions are about social and occupational limitations. A 100 point score signifies the most severe disability.
Measured: Six weeks
The Western Ontario Rotator Cuff Index
This instrument consists of 21 items with 5 further categories: i) 6 items of Physical symptoms,ii) 4 items of sports and recreation functions, iii) 4 items of work functions, iv) 4items of lifestyle functions and v) emotional function with 3 items. The instrument has clear instructions to the patients in addition to the explanation of each item of every category.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start6 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aadil Omer, Ph.D., Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331963
- Sponsor's protocol ID
- REC/01022 Hajra Qureshi
- Status last verified
- Dec 2022
- First submitted
- 2 Apr 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT05331963
- Acronym / sponsor ID
- REC/01022 Hajra Qureshi
- Conditions
- Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Apr 2022 (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.
To determine the effects of functional kinesio taping on subacromial space in athletes with rotator cuff tendinopathy.
Detailed description
Subacromial impingement is a condition among athletes those involved in overhead sports activities such as swimming and volleyball. According to Neer there are two main categories of shoulder impingement, these are structural and functional. Structural: caused by reduction of the subacromial space (SAS) due to bony growth, calcification or soft tissue inflammation whereas functional is caused by or superior migration of the humeral head due to muscular weakness imbalance. In some cases subacromial impingement can be result from a combination of both structural and functional factors.Maintenance of the SAS during arm elevation is thus essential for the prevention of Rotator cuff tendinopathy.
The aim of this randomized controlled trial (RCT) is to evaluate the long-term effects of scapular KT, added to a 6-week rehabilitation program, on the subacromial space at different arm positions in athletes with Rotator cuff tendinopathy. To better understand the underlying mechanisms of KT, our secondary objective addressed the effects of KT on reliving pain-free and full ROM of shoulder joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping with rehabilitation program group | Experimental | Other: Kinesio TapingRehabilitation program will be given to this group in addition to Kinesio taping on skin for 72 hour. |
| Rehabilitation plan group | No intervention | –The rehabilitation program will be provided individually to all participants (twice weekly during the first 4 weeks, then once weekly) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 to 35 years
- Both gender
- Athletes participating in volley ball, tennis, badminton and golf.
- Presence of shoulder pain in abduction and external rotation during training for more than three months
- Three out of five positive results for the following: painful arc, pain or weakness with resisted external rotation, abduction, Neer test, Hawkins Kennedy test, empty can test/Jobe test
Key exclusion criteria (4 listed)
- H/O shoulder fractures,
- Instability or dislocation (positive apprehension and relocation tests)
- Frozen shoulder (All stages)
- Recent shoulder surgery for a shoulder injury
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 |
|---|---|---|
| Kinesio TapingKinesio tape is designed in a specific way that it mimics the human skin nature. It more or less has the same width as the epidermis layer and can be stretched upto 40% of its resting length.Clinically, kinesio tape (KT) is used both alone and with other physiotherapeutic interventions, mainly for the pain control, to reduce inflammation, and to improve functional activity in patients with shoulder pain | Other | Kinesio taping with rehabilitation program group |
Primary outcome
Subacrimial space measurement by Ultrasonography
Time frame: Six weeks
In order to visualize and measure the subacromial space, the Diagnostic Ultrasound will be used with Aquasonic ultrasound gel as the coupling medium. An ultrasound scanner (Canon aplio i600) with frequency of 1 to 22 MHz curved probe will be used in this study to get images. The probe of US will be placed on the anterior-lateral surface of the acromion process, next to the longitudinal axis of the humeral head, and this is the point likely to view the acromion process and humeral head at the same time. The AHD will then measured from inferior surface of acromion process to the superior surface of the humeral head.The distance is basically from cortical layers of both acromion and humerus bone. The acromio humeral distance will be measured at resting position (0° elevation) of shoulder in millimeters.
Visual Analogue Scale
Time frame: Six weeks
This scale consist of 0 to 10 rating in which 0 indicates no pain, and 10 indicates the worst pain.(9) The score of VAS is determined by measuring the distance between the no pain or 0 anchor and to the point where patient draw a mark. A higher score indicates greater pain intensity.
The Disabilities of Arm, Shoulder and Hand Questionnaire
Time frame: Six weeks
The DASH will be used to measure functional disorder, physical disability and symptoms of the upper limbs. It consists of 30 questions. 21 questions are related to specific physical tasks in which a person felt difficulty performing last week. 6 questions are to assess specific symptoms including pain, numbness and stiffness. 3 questions are about social and occupational limitations. A 100 point score signifies the most severe disability.
The Western Ontario Rotator Cuff Index
Time frame: Six weeks
This instrument consists of 21 items with 5 further categories: i) 6 items of Physical symptoms,ii) 4 items of sports and recreation functions, iii) 4 items of work functions, iv) 4items of lifestyle functions and v) emotional function with 3 items. The instrument has clear instructions to the patients in addition to the explanation of each item of every category.
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 8 Dec 2022.
- 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.
Aadil Omer, Ph.D. principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
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 4 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 8 Dec 2022. 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 Pakistan. 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. 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?
Subacrimial space measurement by Ultrasonography (time frame: Six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2022.