Impingement Syndrome, ShoulderNCT05607264
Kinesio Taping Technique Versus Virtual Reality in Patients With Chronic Shoulder Impingement Syndrome
A study testing Kinsiotaping and Conventional treatment in people with Impingement Syndrome, Shoulder, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose of the Study: to compare between the effect of kinesio taping technique versus virtual reality technique in rehabilitation of patients with chronic shoulder impingement syndrome. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impingement Syndrome, Shoulder
- What is being tested?
- Kinsiotaping and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients will be diagnosed with chronic shoulder impingement syndrome (who had supraspinatus tendinitis stage (II) 2. Ages 25-40 years 3. Both sexes will be included. 4. Patients complaint from limitation in the ROM in abduction flexion and external rotation.
- 5. Patient complaint from pain and tendinitis in subacromial area more than 3 in VAS.
- 6. All patients complaint from difficulties in joining ADL activities. 7. All patients will assign written consent form.
Who cannot join
- Subjects with the following criteria will be excluded from the study:
- Shoulder fracture or instability.
- Previous shoulder surgery.
- Arthritis of the glenohumeral or acromioclavicular joints.
- Cervical radiculopathy
- Patients with visual disorders.
Show all 10Show fewer
- Diabetic patients.
- Balance and coordination disorders.
- Tumor and breast cancer.
- Major trauma.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo University, Egypt.
Dokki, 35111
About this study
Official title: Kinesio Taping Technique Versus Virtual Reality in Rehabilitation of Patients With Chronic Shoulder Impingement Syndrome
Purpose of the Study: to compare between the effect of kinesio taping technique versus virtual reality technique in rehabilitation of patients with chronic shoulder impingement syndrome.
Read the detailed description
Rotator cuff disorders are considered to be among the most common causes of shoulder pain and disability encountered in both primary and secondary care, with subacromial impingement syndrome in particular being the most common disorder, resulting in functional loss and disability, of the shoulder.
There is a lack of literature about virtual reality exergaming in subjects with orthopedic problems.
To reduce UL impairment, new therapeutic approaches, such as constraint-induced movement therapy, robotic arm training, and virtual reality therapy (VRT), have been successfully employed over the last decade.
Kinesio taping is the increasingly popular method for preventing and treating sports injuries. The tape helps to maintain the joint position, increases the proprioceptive awareness, and assists in removal of exudates thereby reducing pain and improves the muscle function.
So as there is lag in literature regarding the best type of treatment for patients with chronic impingement syndrome so this study will be conducted to compare between kinesiotaping and virtual reality and to determine the best treatment for patients with chronic Shoulder Impingement Syndrome (SIS).
- Conditions
- Impingement Syndrome, Shoulder
- Being tested
- Kinsiotaping, Motion-controlled VR games, Conventional treatment
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinsiotapingOther
Patients received the kinesiotaping over supraspinatus muscle and deltoid muscle, tape will be removed every three days and subjects will return back to the clinic to reapplication of tape again. Patients received the same therapeutic treatment 3 times/ week for four weeks. KT is air permeable and water resistant, allowing it to stay in place for three to five days.
Motion-controlled VR gamesOther
Virtual Rehab utilizes the unique characteristics of Microsoft Kinects motion technology to track and capture the movements of the patients so that patients become immersed in a 3D environment where they interact with the game. Subjects will include in a supervised virtual reality exergaming program for shoulder movements for 4 weeks, 3 days per week and 10 minutes for session.
Conventional treatmentOther
patients received conventional treatment for chronic shoulder impingement syndrome only.
| Study group | Role | What they receive |
|---|---|---|
| Kinsiotaping | Experimental | patients who received kinesiotaping plus conventional treatment for chronic shoulder impingement syndrome. Receives: Other: Kinsiotaping; Other: Conventional treatment |
| Virtual Reality training | Experimental | patients who received VR training plus conventional treatment for chronic shoulder impingement syndrome. Receives: Other: Motion-controlled VR games; Other: Conventional treatment |
| conventional treatment | Active comparator | patients who received conventional treatment for chronic shoulder impingement syndrome only. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in musculoskeletal disorders of the upper limbs
Assessment by using Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. Scoring the DASH 30-item disability/symptom section:
- Item responses range from 1 (e.g. no difficulty, not at all, not limited, none, strongly disagree) to 5 (e.g. unable, extremely, unable, strongly agree). Scoring the optional 2 4-item high performance sections: 1) Add values of each response, then divide by 4, subtract 1 and multiply by 25: [((sum of values/4) - 1)*25]. 2) Optional modules should not be scored if items are missing. Arabic version of DASH questionnaire will be used, Which is reliable and valid to be used for evaluating upper extremity work related injuries.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in pain intensity
Assessment by using visual analouge scale (VAS). It was used to assess the intensity of pain. Operationally a VAS is usually a horizontal line, l00 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in shoulder range of motion
Assessment by using Electro goniometer. It was used to measure shoulder ROM (flexion, abduction, internal rotation).
Measured: at baseline and after 4 weeks of intervention
Assessing the change in muscle activity of Supraspinatus muscle
Assessment by using Electromyogram (EMG). It was used to measure muscle activity of Supraspinatus, infraspinatus, anterior and middle deltoid.
Measured: at baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Mar 2021
- Primary completion1 Jan 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 Impingement Syndrome, ShoulderStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Ali Mohamed, Cairo University
- Investigators
- Hend Ahmed, Physiotherapist, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607264
- Sponsor's protocol ID
- Hend_PhD_2022
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Technique Versus Virtual Reality in Rehabilitation of Patients With Chronic Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05607264
- Acronym / sponsor ID
- Hend_PhD_2022
- Conditions
- Impingement Syndrome, Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 7 Nov 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.
Purpose of the Study: to compare between the effect of kinesio taping technique versus virtual reality technique in rehabilitation of patients with chronic shoulder impingement syndrome.
Detailed description
Rotator cuff disorders are considered to be among the most common causes of shoulder pain and disability encountered in both primary and secondary care, with subacromial impingement syndrome in particular being the most common disorder, resulting in functional loss and disability, of the shoulder.
There is a lack of literature about virtual reality exergaming in subjects with orthopedic problems.
To reduce UL impairment, new therapeutic approaches, such as constraint-induced movement therapy, robotic arm training, and virtual reality therapy (VRT), have been successfully employed over the last decade.
Kinesio taping is the increasingly popular method for preventing and treating sports injuries. The tape helps to maintain the joint position, increases the proprioceptive awareness, and assists in removal of exudates thereby reducing pain and improves the muscle function.
So as there is lag in literature regarding the best type of treatment for patients with chronic impingement syndrome so this study will be conducted to compare between kinesiotaping and virtual reality and to determine the best treatment for patients with chronic Shoulder Impingement Syndrome (SIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinsiotaping | Experimental | Other: Kinsiotaping, Other: Conventional treatmentpatients who received kinesiotaping plus conventional treatment for chronic shoulder impingement syndrome. |
| Virtual Reality training | Experimental | Other: Motion-controlled VR games, Other: Conventional treatmentpatients who received VR training plus conventional treatment for chronic shoulder impingement syndrome. |
| conventional treatment | Active comparator | Other: Conventional treatmentpatients who received conventional treatment for chronic shoulder impingement syndrome only. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Patients will be diagnosed with chronic shoulder impingement syndrome (who had supraspinatus tendinitis stage (II) 2. Ages 25-40 years 3. Both sexes will be included. 4. Patients complaint from limitation in the ROM in abduction flexion and external rotation.
- 5. Patient complaint from pain and tendinitis in subacromial area more than 3 in VAS.
- 6. All patients complaint from difficulties in joining ADL activities. 7. All patients will assign written consent form.
Key exclusion criteria (10 listed)
- Shoulder fracture or instability.
- Previous shoulder surgery.
- Arthritis of the glenohumeral or acromioclavicular joints.
- Cervical radiculopathy
- Patients with visual disorders.
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 |
|---|---|---|
| KinsiotapingPatients received the kinesiotaping over supraspinatus muscle and deltoid muscle, tape will be removed every three days and subjects will return back to the clinic to reapplication of tape again. Patients received the same therapeutic treatment 3 times/ week for four weeks. KT is air permeable and water resistant, allowing it to stay in place for three to five days. | Other | Kinsiotaping |
| Motion-controlled VR gamesVirtual Rehab utilizes the unique characteristics of Microsoft Kinects motion technology to track and capture the movements of the patients so that patients become immersed in a 3D environment where they interact with the game. Subjects will include in a supervised virtual reality exergaming program for shoulder movements for 4 weeks, 3 days per week and 10 minutes for session. | Other | Virtual Reality training |
| Conventional treatmentpatients received conventional treatment for chronic shoulder impingement syndrome only. | Other | Kinsiotaping, Virtual Reality training, conventional treatment |
Primary outcome
Assessing the change in musculoskeletal disorders of the upper limbs
Time frame: at baseline and after 4 weeks of intervention
Assessment by using Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. Scoring the DASH 30-item disability/symptom section: 1) Item responses range from 1 (e.g. no difficulty, not at all, not limited, none, strongly disagree) to 5 (e.g. unable, extremely, unable, strongly agree). Scoring the optional 2 4-item high performance sections: 1) Add values of each response, then divide by 4, subtract 1 and multiply by 25: [((sum of values/4) - 1)*25]. 2) Optional modules should not be scored if items are missing. Arabic version of DASH questionnaire will be used, Which is reliable and valid to be used for evaluating upper extremity work related injuries.
Assessing the change in pain intensity
Time frame: at baseline and after 4 weeks of intervention
Assessment by using visual analouge scale (VAS). It was used to assess the intensity of pain. Operationally a VAS is usually a horizontal line, l00 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
Assessing the change in shoulder range of motion
Time frame: at baseline and after 4 weeks of intervention
Assessment by using Electro goniometer. It was used to measure shoulder ROM (flexion, abduction, internal rotation).
Assessing the change in muscle activity of Supraspinatus muscle
Time frame: at baseline and after 4 weeks of intervention
Assessment by using Electromyogram (EMG). It was used to measure muscle activity of Supraspinatus, infraspinatus, anterior and middle deltoid.
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 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Hend Ahmed, Physiotherapist principal investigator
Cairo 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 Kinsiotaping and Conventional treatment in people with Impingement Syndrome, Shoulder, run by Cairo University at 1 site in Egypt.
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 10 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 7 Nov 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 Egypt. 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?
Assessing the change in musculoskeletal disorders of the upper limbs (time frame: at baseline and after 4 weeks of intervention). 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 7 Nov 2022.