Subacromial Impingement SyndromeNCT06156475
The Physiotherapy Approaches in Patients With Subacromial Impingement Syndrome
A study testing Proprioception exercises, Proprioception exercises with Electromyographic Biofeedback and Wand Exercise in people with Subacromial Impingement Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of Electromyographic Biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality in patients with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Proprioception exercises, Proprioception exercises with Electromyographic Biofeedback and Wand Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Dec 2021
- 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
- Being diagnosed with subacromial impingement syndrome,
- Being between the ages of 18 and 65,
- Not having received medical treatment,
- Not having received a shoulder-related physiotherapy program in the last year,
- Not having had any shoulder-related surgery,
Who cannot join
- Neurological deficits of the upper extremity and the presence of another orthopedic disorder, rheumatic or congenital disease other than subacromial impingement syndrome,
- Presence of mental problem,
- Having received corticosteroid treatment in the last year,
- Upper extremity fracture,
- Acute cervical pathology,
- Having cardiovascular and systemic diseases that prevent working,
- Pregnancy,
- Those with communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Electromyographic Biofeedback and Proprioception Exercises on Pain and Functionality in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Study
The aim of this study is to investigate the effectiveness of Electromyographic Biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality in patients with subacromial impingement syndrome.
Read the detailed description
This study is planned as a prospective, randomized clinical study. Patients with subacromial impingement syndrome who volunteered to participate in the study, met the inclusion criteria, and signed the consent form were randomly assigned to the proprioception exercise group and the proprioception exercise with electromyographic biofeedback group. Demographic and clinical data of the patients were recorded. Shoulder function with Disabilities of the Arm, Shoulder and Hand scale, pain with VAS, painless active shoulder flexion, abduction, and external-internal rotation with goniometer, muscle strength with Manual Muscle Tester, proprioception (55°-90°- 125° angles of flexion and abduction, and angular deviations) with the Laser-pointer assisted angle reproduction test were evaluated, and patient satisfaction was evaluated with The Global Rating of Change Scale. After the initial evaluations were completed, only proprioception exercises and proprioception exercises with EMG-BF were applied 2 days a week for 8 weeks. Additionally, both groups were given Want exercises.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Proprioception exercises, Proprioception exercises with Electromyographic Biofeedback, Wand Exercise
- Keywords
- Shoulder impingement syndrome, shoulder pain, proprioception, biofeedback
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception exercisesProcedure or surgery
Patients trained for proprioception exercises.
Proprioception exercises with Electromyographic BiofeedbackProcedure or surgery
Patients trained for Proprioception exercises with Electromyographic Biofeedback
Wand ExerciseProcedure or surgery
Patients were educated with wand exercises.
| Study group | Role | What they receive |
|---|---|---|
| Proprioception Exercise Group | Experimental | Wand exercises and Proprioception exercises Receives: Procedure: Proprioception exercises; Procedure: Wand Exercise |
| Proprioception exercises with Electromyographic Biofeedback | Active comparator | Wand exercises and Proprioception exercises with Electromyographic Biofeedback Receives: Procedure: Proprioception exercises with Electromyographic Biofeedback; Procedure: Wand Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand scale
The Disabilities of the Arm, Shoulder and Hand scale was used to measure shoulder function. The Disabilities of the Arm, Shoulder and Hand scale consists of 30 items. The total score that can be obtained from items scored between 1-5 varies between 0-100. An increase in the score indicates a decrease in function.
Measured: 8 weeks
Secondary outcomes (5)
Visual analogue scale
The severity of pain was measured Visual analogue scale. ccording to this scale, patients rated their pain between 0 and 10. As the score increases, the pain increases.
Measured: 8 weeks
Joint range of motion
Active shoulder flexion, abduction, and external-internal rotation range of motion was measured with goniometer.
Measured: 8 weeks
Muscle strength
Shoulder flexion, abduction, and external-internal rotator muscle strength was measured with manual muscle tester.
Measured: 8 weeks
Proprioception
To evaluate joint position sense, laser pointer-assisted angle reproduction test was applied for measurements at 55°-90°-125° flexion and abduction angles.
Measured: 8 weeks
Patient satisfaction
The amount of improvement or deterioration in patients was assessed with the "Global Rating Change Scale".This scale is scored according to a 7-point Likert type (-3: much worse, -2: worse, -1: slightly worse, 0: the same, 1: slightly better, 2: quite better, 3: much better).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 May 2021
- Primary completion1 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- The study consisted of patients with subacromial impingement syndrome evaluated by an orthopedist. Patients who met the inclusion criteria were divided into two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa
- Investigators
- Ebru Kaya Mutlu, Professor, Principal investigator, Bandırma Onyedi Eylül UniversityBuse Aydin, M.Sc., Study chair, Istabul Aydin UniversityYasemin Karaaslan, Asst. Prof., Study chair, Mustafa Kemal UniversityHanifegül Taskiran, Professor, Study chair, Istanbul Aydın UniversityNezih Ziroglu, MD, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156475
- Sponsor's protocol ID
- Istanbul Aydin University
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electromyographic Biofeedback and Proprioception Exercises on Pain and Functionality in Patients With Subacromial Impingement Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06156475
- Acronym / sponsor ID
- Istanbul Aydin University
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Shoulder impingement syndrome, shoulder pain, proprioception, biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Dec 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 aim of this study is to investigate the effectiveness of Electromyographic Biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality in patients with subacromial impingement syndrome.
Detailed description
This study is planned as a prospective, randomized clinical study. Patients with subacromial impingement syndrome who volunteered to participate in the study, met the inclusion criteria, and signed the consent form were randomly assigned to the proprioception exercise group and the proprioception exercise with electromyographic biofeedback group. Demographic and clinical data of the patients were recorded. Shoulder function with Disabilities of the Arm, Shoulder and Hand scale, pain with VAS, painless active shoulder flexion, abduction, and external-internal rotation with goniometer, muscle strength with Manual Muscle Tester, proprioception (55°-90°- 125° angles of flexion and abduction, and angular deviations) with the Laser-pointer assisted angle reproduction test were evaluated, and patient satisfaction was evaluated with The Global Rating of Change Scale. After the initial evaluations were completed, only proprioception exercises and proprioception exercises with EMG-BF were applied 2 days a week for 8 weeks. Additionally, both groups were given Want exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study consisted of patients with subacromial impingement syndrome evaluated by an orthopedist. Patients who met the inclusion criteria were divided into two groups.
| Arm | Type | Receives |
|---|---|---|
| Proprioception Exercise Group | Experimental | Procedure: Proprioception exercises, Procedure: Wand ExerciseWand exercises and Proprioception exercises |
| Proprioception exercises with Electromyographic Biofeedback | Active comparator | Procedure: Proprioception exercises with Electromyographic Biofeedback, Procedure: Wand ExerciseWand exercises and Proprioception exercises with Electromyographic Biofeedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with subacromial impingement syndrome,
- Being between the ages of 18 and 65,
- Not having received medical treatment,
- Not having received a shoulder-related physiotherapy program in the last year,
- Not having had any shoulder-related surgery,
Key exclusion criteria (8 listed)
- Neurological deficits of the upper extremity and the presence of another orthopedic disorder, rheumatic or congenital disease other than subacromial impingement syndrome,
- Presence of mental problem,
- Having received corticosteroid treatment in the last year,
- Upper extremity fracture,
- Acute cervical pathology,
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 |
|---|---|---|
| Proprioception exercisesPatients trained for proprioception exercises. | Procedure or surgery | Proprioception Exercise Group |
| Proprioception exercises with Electromyographic BiofeedbackPatients trained for Proprioception exercises with Electromyographic Biofeedback | Procedure or surgery | Proprioception exercises with Electromyographic Biofeedback |
| Wand ExercisePatients were educated with wand exercises. | Procedure or surgery | Proprioception Exercise Group, Proprioception exercises with Electromyographic Biofeedback |
Primary outcome
Disabilities of the Arm, Shoulder and Hand scale
Time frame: 8 weeks
The Disabilities of the Arm, Shoulder and Hand scale was used to measure shoulder function. The Disabilities of the Arm, Shoulder and Hand scale consists of 30 items. The total score that can be obtained from items scored between 1-5 varies between 0-100. An increase in the score indicates a decrease in function.
5 secondary outcomes
Visual analogue scale
Time frame: 8 weeks
Joint range of motion
Time frame: 8 weeks
Muscle strength
Time frame: 8 weeks
Proprioception
Time frame: 8 weeks
Patient satisfaction
Time frame: 8 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 11 Dec 2023.
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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.
Ebru Kaya Mutlu, Professor principal investigator
Bandırma Onyedi Eylül University
Buse Aydin, M.Sc. study chair
Istabul Aydin University
Yasemin Karaaslan, Asst. Prof. study chair
Mustafa Kemal 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 Proprioception exercises, Proprioception exercises with Electromyographic Biofeedback and Wand Exercise in people with Subacromial Impingement Syndrome, run by Istanbul University - Cerrahpasa 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 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 11 Dec 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. 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?
Disabilities of the Arm, Shoulder and Hand scale (time frame: 8 weeks). 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 11 Dec 2023.