KinesiotapeNCT04242381
Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome
A study testing Cold Application, Kinesiotaping Application and Exercise treatment in people with Kinesiotape and Exercise, run by Kars State Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Kinesiotape, Exercise, Ultrasound
- What is being tested?
- Cold Application, Kinesiotaping Application and Exercise treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Feb 2017
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least three positive results in the Hawkins-Kennedy, Neer, empty can, drop-arm, and lift-off tests
- magnetic resonance imaging findings
- age between 45 and 70 years
Who cannot join
- Patients who received physical therapy for the shoulder region within the past three months or those with a history of injections to the shoulder joint,
- cervical pathologies,
- clinical conditions accompanied by neuromotor or sensory dysfunction,
- history of malignancy,
- pregnancies,
- partial or total rupture in the supraspinatus tendon,
- adhesive capsulitis,
- diabetes or chronic liver, or kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Effect Of Kinesiotaping on Pain, Functionality, and Ultrasound Parameters In Patients With Shoulder Impingement Syndrome: A Randomized Sham-Controlled Study
We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).
Read the detailed description
A total of 75 patients with SIS were randomly classified into the following three groups: kinesiotaping (KT), exercise (EX) and sham-kinesiotaping (sham-KT). Each group was underwent two weeks treatment program. The patients were then evaluated in terms of pain analyzed using the visual analog scale (VAS), joint range of motion, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire before and after treatment. In addition, supraspinatus tendon (SsT) thickness and acromiohumeral distance (AHD) parameters were measured using ultrasonography (US). All parameters were measured before and after treatment.
- Conditions
- Kinesiotape, Exercise, Ultrasound
- Being tested
- Cold Application, Kinesiotaping Application, Exercise treatment, Sham Kinesio taping application
- Keywords
- Kinesiotape, exercise, ultrasound
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold ApplicationOther
At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes.
Kinesiotaping ApplicationOther
KT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval)
Exercise treatmentOther
EX treatment was administered for 10 days with 3 sessions/day. A triphasic exercise program was administered to the patients. Before starting the exercise program, the patients were instructed to not perform the movements exceeding 90° overhead. The exercise program was initiated using codman pendulum, passive joint motion range (with a 1-m stick), and posterior capsule stretching exercise. Shoulder wheel, finger ladder, and shoulder strengthening exercise with theraband were added to the exercise programs of patients with full or near total range of motion and pain relief. Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise. The patients were followed up via telephone to make sure they were adhering to their exercise programs.
Sham Kinesio taping applicationOther
Sham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area. The kinesiotape was applied twice for five days with 2-day intervals
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cold application, Kinesiotaping treatment | Experimental | Cold application: At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes.
Kinesiotaping application: KT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval). Receives: Other: Cold Application; Other: Kinesiotaping Application |
| Group 2: Cold application, EX treatment | Experimental | EX treatment was administered for 10 days with 3 sessions/day. A triphasic exercise program was administered to the patients. Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise. The patients were followed up via telephone to make sure they were adhering to their exercise programs. Receives: Other: Cold Application; Other: Exercise treatment |
| Group 3: Cold application, sham-KT treatment | Sham comparator | Sham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area. The kinesiotape was applied twice for five days with 2-day intervals Receives: Other: Cold Application; Other: Sham Kinesio taping application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
The severity of shoulder pain (resting, activity, and night pain) in the patients was evaluated through the VAS score. A VAS score of 0 represented no pain, whereas a score of 10 represented the most severe pain; the patients were asked to mark the average severity of the pain they felt during the past week and the marked point was measured using a centimeter ruler and recorded.
Measured: 4 weeks
Functional Status
Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire: This questionnaire comprises three sections. The first section comprises 30 items: 21 items assess the patient's difficulties in performing daily activities, 5 assess symptoms (pain, activity-related pain, tingling, stiffness, and weakness), and each of the remaining 4 items assesses social function, work, sleep, and self-confidence. All items are rated on a 5-point Likert-type scale (1, no difficulty; 2, mild difficulty; 3, moderate difficulty; 4, extreme difficulty; 5, cannot perform at all). The total score possible through this questionnaire ranges from 0 to 100 (0, no disability; 100, maximum disability). Furthermore, Turkish reliability and validity have been performed for this questionnaire.
Measured: 4 weeks
Joint range of motion measurements
Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).
Measured: 4 weeks
Ultrasonography
US was performed using a 7.5-mHz linear probe in the B mode (Mindray-China). Supraspinatus tendon (SsT) thickness was measured at three different points (10, 15, and 20 mm) lateral to the tendon after identifying the biceps tendon in the transverse section and the average of measurements was recorded. Acromiohumeral distance (AHD) was assessed by linearly measuring the distance between the inferior of the acromion from the anterior of the shoulder and the superior of the humeral head
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiotapeStudies of the same condition, open and under way.
- 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
- A Randomized Sham-Controlled Study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242381
- Sponsor's protocol ID
- HNEAH-KAEK 2016/269
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect Of Kinesiotaping on Pain, Functionality, and Ultrasound Parameters In Patients With Shoulder Impingement Syndrome: A Randomized Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT04242381
- Acronym / sponsor ID
- HNEAH-KAEK 2016/269
- Conditions
- Kinesiotape, Exercise, Ultrasound
- Keywords
- Kinesiotape, exercise, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 27 Jan 2020 (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.
We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).
Detailed description
A total of 75 patients with SIS were randomly classified into the following three groups: kinesiotaping (KT), exercise (EX) and sham-kinesiotaping (sham-KT). Each group was underwent two weeks treatment program. The patients were then evaluated in terms of pain analyzed using the visual analog scale (VAS), joint range of motion, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire before and after treatment. In addition, supraspinatus tendon (SsT) thickness and acromiohumeral distance (AHD) parameters were measured using ultrasonography (US). All parameters were measured before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A Randomized Sham-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cold application, Kinesiotaping treatment | Experimental | Other: Cold Application, Other: Kinesiotaping ApplicationCold application: At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes. Kinesiotaping application: KT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval). |
| Group 2: Cold application, EX treatment | Experimental | Other: Cold Application, Other: Exercise treatmentEX treatment was administered for 10 days with 3 sessions/day. A triphasic exercise program was administered to the patients. Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise. The patients were followed up via telephone to make sure they were adhering to their exercise programs. |
| Group 3: Cold application, sham-KT treatment | Sham comparator | Other: Cold Application, Other: Sham Kinesio taping applicationSham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area. The kinesiotape was applied twice for five days with 2-day intervals |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least three positive results in the Hawkins-Kennedy, Neer, empty can, drop-arm, and lift-off tests
- magnetic resonance imaging findings
- age between 45 and 70 years
Key exclusion criteria (8 listed)
- Patients who received physical therapy for the shoulder region within the past three months or those with a history of injections to the shoulder joint,
- cervical pathologies,
- clinical conditions accompanied by neuromotor or sensory dysfunction,
- history of malignancy,
- pregnancies,
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 |
|---|---|---|
| Cold ApplicationAt the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes. | Other | Group 1: Cold application, Kinesiotaping treatment, Group 2: Cold application, EX treatment, Group 3: Cold application, sham-KT treatment |
| Kinesiotaping ApplicationKT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval) | Other | Group 1: Cold application, Kinesiotaping treatment |
| Exercise treatmentEX treatment was administered for 10 days with 3 sessions/day. A triphasic exercise program was administered to the patients. Before starting the exercise program, the patients were instructed to not perform the movements exceeding 90° overhead. The exercise program was initiated using codman pendulum, passive joint motion range (with a 1-m stick), and posterior capsule stretching exercise. Shoulder wheel, finger ladder, and shoulder strengthening exercise with theraband were added to the exercise programs of patients with full or near total range of motion and pain relief. Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise. The patients were followed up via telephone to make sure they were adhering to their exercise programs. | Other | Group 2: Cold application, EX treatment |
| Sham Kinesio taping applicationSham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area. The kinesiotape was applied twice for five days with 2-day intervals | Other | Group 3: Cold application, sham-KT treatment |
Primary outcome
Pain Level
Time frame: 4 weeks
The severity of shoulder pain (resting, activity, and night pain) in the patients was evaluated through the VAS score. A VAS score of 0 represented no pain, whereas a score of 10 represented the most severe pain; the patients were asked to mark the average severity of the pain they felt during the past week and the marked point was measured using a centimeter ruler and recorded.
Functional Status
Time frame: 4 weeks
Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire: This questionnaire comprises three sections. The first section comprises 30 items: 21 items assess the patient's difficulties in performing daily activities, 5 assess symptoms (pain, activity-related pain, tingling, stiffness, and weakness), and each of the remaining 4 items assesses social function, work, sleep, and self-confidence. All items are rated on a 5-point Likert-type scale (1, no difficulty; 2, mild difficulty; 3, moderate difficulty; 4, extreme difficulty; 5, cannot perform at all). The total score possible through this questionnaire ranges from 0 to 100 (0, no disability; 100, maximum disability). Furthermore, Turkish reliability and validity have been performed for this questionnaire.
Joint range of motion measurements
Time frame: 4 weeks
Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).
Ultrasonography
Time frame: 4 weeks
US was performed using a 7.5-mHz linear probe in the B mode (Mindray-China). Supraspinatus tendon (SsT) thickness was measured at three different points (10, 15, and 20 mm) lateral to the tendon after identifying the biceps tendon in the transverse section and the average of measurements was recorded. Acromiohumeral distance (AHD) was assessed by linearly measuring the distance between the inferior of the acromion from the anterior of the shoulder and the superior of the humeral head
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 27 Jan 2020.
- 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 Cold Application, Kinesiotaping Application and Exercise treatment in people with Kinesiotape and Exercise, run by Kars State Hospital 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 3 inclusion and 8 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 27 Jan 2020. 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 Level (time frame: 4 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 27 Jan 2020.