Subacromial Impingement SyndromeNCT04392934
Conservative Physiotherapy and Acromion Morphology
A study testing a conservative physiotherapy protocol in people with Subacromial Impingement Syndrome and Morphologic Change, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Subacromial Impingement Syndrome, Morphologic Change
- What is being tested?
- a conservative physiotherapy protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2020to 30 Mar 2020
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.
Who cannot join
- Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short-term Effects of a Conservative Physiotherapy Method in Subacromial Impingement Syndrome and Its Relation to Acromion Morphology
In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.
Read the detailed description
The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment.
- Being tested
- a conservative physiotherapy protocol
- Keywords
- physiotherapy, acromion morphology, subacromial impingement syndrome
- 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.
a conservative physiotherapy protocolProcedure or surgery
5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week.
| Study group | Role | What they receive |
|---|---|---|
| flat shape acromion group | Experimental | a conservative physiotherapy protocol was applied for 4 weeks Receives: Procedure: a conservative physiotherapy protocol |
| curved shape acromion group | Experimental | a conservative physiotherapy protocol was applied for 4 weeks Receives: Procedure: a conservative physiotherapy protocol |
| hooked shape acromion group | Experimental | a conservative physiotherapy protocol was applied for 4 weeks Receives: Procedure: a conservative physiotherapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain at rest and pain at activity was measured by Visual Analog Scale (VAS). High score was determined as high level of pain. Visual analog scale (VAS) was ranging from 0 cm (no pain) to 10 cm (worst imaginable pain).
Measured: 4 weeks
Muscle strength
Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).
Measured: 4 weeks
Range of motion
Goniometric measurements were applied by a universal goniometer to determine the range of motion in terms of flexion, extension, abduction, adduction, internal and external rotation directions.
Measured: 4 weeks
Joint position sense
The joint position sense was evaluated by a laser pointer. During the test, 90˚ shoulder flexion and 90˚ shoulder abduction movements were evaluated. A laser pointer was fixed with a velcro 5 cm above the elbow. The patient was asked to bring the shoulder to 90˚ flexion while the patient's eyes were open and meanwhile, the measurement was made by the physiotherapist with a goniometer. The patient was asked to fix this position for 10 seconds. The projection of the laser pointer on millimeter paper was marked. The patient repeated this movement 3 times with eyes open and memorized it. The patient returned to the neutral position and closed her eyes then repeated the flexion movement 3 times and the projection of the laser pointer on millimeter paper was marked. The same procedure was performed for shoulder abduction. The deviation between the measurements was calculated.
Measured: 4 weeks
Painful arc sign
The patient was asked to perform active shoulder abduction, and the difference between the angle at which the pain first occurred and the angle at which the pain ended was noted during this movement pattern. Measurements were made on the affected shoulder joint by a goniometer
Measured: 4 weeks
Functionality
To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.
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 posted19 May 2020
- Study start10 Jan 2020
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
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.
- 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
- Factorial
- Model description
- Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begümhan Turhan, Hasan Kalyoncu University
- Investigators
- Begumhan Turhan, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392934
- Sponsor's protocol ID
- 2019/100
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 19 May 2020
- 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 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effects of a Conservative Physiotherapy Method in Subacromial Impingement Syndrome and Its Relation to Acromion Morphology
- ClinicalTrials.gov ID
- NCT04392934
- Acronym / sponsor ID
- 2019/100
- Keywords
- physiotherapy, acromion morphology, subacromial impingement syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 19 May 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.
In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.
Detailed description
The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.
| Arm | Type | Receives |
|---|---|---|
| flat shape acromion group | Experimental | Procedure: a conservative physiotherapy protocola conservative physiotherapy protocol was applied for 4 weeks |
| curved shape acromion group | Experimental | Procedure: a conservative physiotherapy protocola conservative physiotherapy protocol was applied for 4 weeks |
| hooked shape acromion group | Experimental | Procedure: a conservative physiotherapy protocola conservative physiotherapy protocol was applied for 4 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.
Key exclusion criteria (1 listed)
- Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.
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 |
|---|---|---|
| a conservative physiotherapy protocol5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week. | Procedure or surgery | curved shape acromion group, flat shape acromion group, hooked shape acromion group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 4 weeks
Pain at rest and pain at activity was measured by Visual Analog Scale (VAS). High score was determined as high level of pain. Visual analog scale (VAS) was ranging from 0 cm (no pain) to 10 cm (worst imaginable pain).
Muscle strength
Time frame: 4 weeks
Muscle strength tests for shoulder flexion, extension, abduction, adduction, internal and external rotation were done by a dynamometer (NK-500, AIPU, Anhui, China).
Range of motion
Time frame: 4 weeks
Goniometric measurements were applied by a universal goniometer to determine the range of motion in terms of flexion, extension, abduction, adduction, internal and external rotation directions.
Joint position sense
Time frame: 4 weeks
The joint position sense was evaluated by a laser pointer. During the test, 90˚ shoulder flexion and 90˚ shoulder abduction movements were evaluated. A laser pointer was fixed with a velcro 5 cm above the elbow. The patient was asked to bring the shoulder to 90˚ flexion while the patient's eyes were open and meanwhile, the measurement was made by the physiotherapist with a goniometer. The patient was asked to fix this position for 10 seconds. The projection of the laser pointer on millimeter paper was marked. The patient repeated this movement 3 times with eyes open and memorized it. The patient returned to the neutral position and closed her eyes then repeated the flexion movement 3 times and the projection of the laser pointer on millimeter paper was marked. The same procedure was performed for shoulder abduction. The deviation between the measurements was calculated.
Painful arc sign
Time frame: 4 weeks
The patient was asked to perform active shoulder abduction, and the difference between the angle at which the pain first occurred and the angle at which the pain ended was noted during this movement pattern. Measurements were made on the affected shoulder joint by a goniometer
Functionality
Time frame: 4 weeks
To assess the functional levels of the patients, the Shoulder Pain and Disability Index (SPADI) was used.
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 19 May 2020.
Related trials for Subacromial Impingement Syndrome
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
RecruitingObservational study
Acromial Morphology: Reliability of CT-based Assessment and Relationship With Age in a Series of 420 Patients
Shoulder Impingement Syndrome, Acromial Morphology
Recruiting
Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
Rotator Cuff Related Shoulder Pain, Rotator Cuff Tendinopathy
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.
Begumhan Turhan study director
Hasan Kalyoncu 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 a conservative physiotherapy protocol in people with Subacromial Impingement Syndrome and Morphologic Change, run by Hasan Kalyoncu University 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 1 inclusion and 1 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 19 May 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. 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?
Visual Analog Scale (VAS) (time frame: 4 weeks). The study lists 6 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 19 May 2020.