Subacromial Impingement SyndromeNCT05530005
Traditional Physiotherapy Protocol vs Prescribed Exercises in Impingement Syndrome of the Shoulder
A study testing Manual Therapy in people with Subacromial Impingement Syndrome, run by Klinika Ruchu at 1 site in Poland.
Trial summary
Pain and limitation of shoulder mobility resulting from sub-shoulder syndrome called sub acromion impingement syndrome (SIS) are a big social problem in highly developed countries. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Manual Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 3 Dec 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-5 0 years,
- shoulder pain lasting from 3 months to 1 year,
- no surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease.
- ailments in scales I and II according to Neer.
Who cannot join
- surgical procedures and other surgical interventions
- features of the total rupture of the rotator cuff muscle- III⁰ according to Neer scale, confirmed in imaging studies.
- age under 25 or over 50 years
- diagnosed in ultrasound or MRI with complete damage to the muscles of the rotator cuff,
- the duration of the ailment is up to 3 months or more than 1 year.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Klinika Ruchu
Warsaw, Masovian Voivodeship, 02654
andrzej krzysztof Kepczynski, Msc, +48663663383, andrzej.kepczynski@klinikaruchu.pl
About this study
Official title: Comparison of the Traditional Physiotherapy Protocol With Monitoring Individually Prescribed Exercises in Impingement Syndrome of the Shoulder Joint
Pain and limitation of shoulder mobility resulting from sub-shoulder syndrome called sub acromion impingement syndrome (SIS) are a big social problem in highly developed countries. This work aims to compare the method of treating SIS ailments taking into account the monitored exercises on their own- hands off, to the traditional method of individual physiotherapy considering manual therapy, TENS and local cryotherapy- hands on. The study will qualify people aged 18-50 years without previous injections, surgical procedures and physiotherapy within the shoulder joint. The initial examination of the participants will include: ultrasound examination, Neer test, functional mobility test according to FMS, clinical examination: palpation of the joint area, cross body adduction test, radial artery pulse test, numerical pain scale 0-10, DASH questionnaire. After the initial checkups, 60 people will be qualified for the proper examination. Selected participants will be divided into two groups of 30 people, each group consisting of 15 women and 15 men. The first group will undergo self-therapy for 3-5 months. The subjects will exercise independently for about 1.5 hours a day, three times a week. Every two weeks, each subject will be admitted to a follow-up visit, during which the physiotherapist will recommend another set of exercises and check the progress. The second group will undergo traditional physiotherapy three times a week for a period of three months. After a period of 3-5 months, both groups will undergo the same examination as initially. The results of both studies will be compared in both groups. The groups will then be compared to each other.
Read the detailed description
The aim of the study is to compare the effectiveness of individual physiotherapy, using manual therapy, exercises conducted individually and physical therapy to therapy assuming recommendations for self-performed exercises in accordance with the physiotherapist's recommendations. Research questions?
- Will the effects of self-directed physiotherapy be comparable in terms of reducing pain, improving range of motion, function, and quality of life, and helping reduce the cost of therapy compared to physiotherapy in constant contact?
- Will the results of subacromial space measurements in ultrasound examination in both groups before and after therapy correlate with clinical and functional tests? The duration of the intervention is assumed at one year. The study will last 3 months. About 60 people will be included in the study, who will be divided into 2 groups, about 30 people each (30 men and 30 women). Patients will be aged 18-50 years. The choice of the group will depend on where the patient comes forward. Patients who report to the Klinika Ruchu will be conducted with individual outpatient physiotherapy - "hands-on". Patients who apply to the Zdrowe Miejsce will be guided by therapy through self-practice "hands off".
The study of patients will include:
- ultrasound diagnostics,
- Neer test,
- palpation of the joint area, taking into account the assessment of the condition of the rotator cuff muscles and muscle around the scapula to exclude possible pronounced atrophy, which may indicate damage to the nerve roots from the C5-6 level, sometimes 7- Erb damage,
- tests of shoulder mobility according to FMS, 4. cross body abduction stress test to exclude changes in the shoulder-clavicle joint, 5. numerical scale of pain level 0-10, 6. assessment of the pulse on the radial artery in order to exclude damage to the subclavian artery, 7. tension tests of long nerves of the upper kk, 8. DASH Upper Limb Disability Questionnaire.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Manual Therapy
- Keywords
- subacromial bursa, 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.
Manual TherapyOther
Manual Therapy according to Kaltenborn Evjenth method. Exercises with PT resistance, massage.
| Study group | Role | What they receive |
|---|---|---|
| Hands on | Active comparator | Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer. Receives: Other: Manual Therapy |
| Hands off | No intervention | Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound examination
The measurement will be carried out on one ultrasound device. In all patients, a measurement of the subscapular space of the shoulder joint in the ultrasound image will be performed. Ultrasound examinations are used in the diagnosis of the shoulder joint to assess the thickness and quality of tendons and recognized them. Examinations will take place in the positions: of the suspended upper limb and in the position of visit and external rotation in the shoulder joint. Putting on the Power Doppler mesh will allow you to exclude visible inflammation of the examined area while excluding ongoing acute inflammation. In case of doubt or when the examination shows acute inflammation, the patient will be referred to a doctor and a specialist. The measurement will be carried out on one ultrasound device - Siemens Acuson X150, 10-5 MHz linear fisheries. , by one experienced physiotherapist in accordance with the guidelines
Measured: 3 month of observation
Neer test
Performing the test: the subject sits sideways to the examiner, the upper c. of the subject with a bent elbow joint and a bent and brought shoulder joint. The examiner resists the subject's elbow from above, who slightly presses his elbow on the investigator's hand. Results: + pain appears in the test position or after pressure, - no pain, +/- the subject is not able to assess the pain
Measured: 3 month of observation
Palpation.
The examination is carried out in a sitting position with the upper limb suspended.
Measured: 3 month of observation
Shoulder joint mobility according to FMS
The test evaluates the bilateral mobility of the entire shoulder girdle. The test evaluates the bilateral mobility of the entire shoulder girdle, combining internal rotation with arrival and external rotation with visitation. Proper mobility also requires mobility in the shoulder-scapular joint and in the thoracic spine.
Measured: 3 month of observation
Cross-body abduction stress test
The subject sits with a limb bent to 90⁰ in the shoulder and elbow joint. Performs the movement of horizontal attachment in the shoulder joint
Measured: 3 month of observation
The numerical scale of pain level 0-10
The patient is asked to determine the level of pain on a scale of 0-10. The subject is asked to determine the level of pain on a scale of 0-10, in which it is determined how severe the pain is, indicating the appropriate digit on a scale from 0 to 10, where 0 corresponds - "I do not feel pain at all", - 10 - "the worst pain I can imagine"
Measured: 3 month of observation
Assessment of pulse on the radial artery
Examination is performed to exclude the syndrome stealing of the subclavian artery
Measured: 3 month of observation
DASH Questionnaire
The questionnaire is concerning upper limb disability. The subject assesses his ability to perform the following actions last week by outlining the number of the most accurate answer in Table 1.
The subject then assesses the severity of symptoms last week by outlining the number in Table 2 of the most accurate answer. After completing the test, we count the sum of points.
DASH Limitations and Symptoms Index = -1)]×25 where: n = numbers of the answers given. If more than three questions are left unanswered, the DASH cannot be calculated.
Measured: 3 month of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jun 2022
- Primary completion30 Jul 2022
- Study completion3 Dec 2023 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinika Ruchu
- Sponsor type
- University, hospital or other
- Collaborators
- Józef Piłsudski University of Physical Education
- Responsible party
- Sponsor
- Investigators
- Andrzej Kepczynski, Study director, Klinika Ruchu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530005
- Sponsor's protocol ID
- SKE01-11/2022
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Traditional Physiotherapy Protocol With Monitoring Individually Prescribed Exercises in Impingement Syndrome of the Shoulder Joint
- ClinicalTrials.gov ID
- NCT05530005
- Acronym / sponsor ID
- SKE01-11/2022
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- subacromial bursa, impingement syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinika RuchuUniversity, hospital or other
- Collaborators
- Józef Piłsudski University of Physical Education
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 3 Dec 2023 (estimated)
- First posted
- 7 Sep 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.
Pain and limitation of shoulder mobility resulting from sub-shoulder syndrome called sub acromion impingement syndrome (SIS) are a big social problem in highly developed countries. This work aims to compare the method of treating SIS ailments taking into account the monitored exercises on their own- hands off, to the traditional method of individual physiotherapy considering manual therapy, TENS and local cryotherapy- hands on. The study will qualify people aged 18-50 years without previous injections, surgical procedures and physiotherapy within the shoulder joint. The initial examination of the participants will include: ultrasound examination, Neer test, functional mobility test according to FMS, clinical examination: palpation of the joint area, cross body adduction test, radial artery pulse test, numerical pain scale 0-10, DASH questionnaire. After the initial checkups, 60 people will be qualified for the proper examination. Selected participants will be divided into two groups of 30 people, each group consisting of 15 women and 15 men. The first group will undergo self-therapy for 3-5 months. The subjects will exercise independently for about 1.5 hours a day, three times a week. Every two weeks, each subject will be admitted to a follow-up visit, during which the physiotherapist will recommend another set of exercises and check the progress. The second group will undergo traditional physiotherapy three times a week for a period of three months. After a period of 3-5 months, both groups will undergo the same examination as initially. The results of both studies will be compared in both groups. The groups will then be compared to each other.
Detailed description
The aim of the study is to compare the effectiveness of individual physiotherapy, using manual therapy, exercises conducted individually and physical therapy to therapy assuming recommendations for self-performed exercises in accordance with the physiotherapist's recommendations. Research questions?
- Will the effects of self-directed physiotherapy be comparable in terms of reducing pain, improving range of motion, function, and quality of life, and helping reduce the cost of therapy compared to physiotherapy in constant contact?
- Will the results of subacromial space measurements in ultrasound examination in both groups before and after therapy correlate with clinical and functional tests? The duration of the intervention is assumed at one year. The study will last 3 months. About 60 people will be included in the study, who will be divided into 2 groups, about 30 people each (30 men and 30 women). Patients will be aged 18-50 years. The choice of the group will depend on where the patient comes forward. Patients who report to the Klinika Ruchu will be conducted with individual outpatient physiotherapy - "hands-on". Patients who apply to the Zdrowe Miejsce will be guided by therapy through self-practice "hands off".
The study of patients will include:
- ultrasound diagnostics,
- Neer test,
- palpation of the joint area, taking into account the assessment of the condition of the rotator cuff muscles and muscle around the scapula to exclude possible pronounced atrophy, which may indicate damage to the nerve roots from the C5-6 level, sometimes 7- Erb damage,
- tests of shoulder mobility according to FMS, 4. cross body abduction stress test to exclude changes in the shoulder-clavicle joint, 5. numerical scale of pain level 0-10, 6. assessment of the pulse on the radial artery in order to exclude damage to the subclavian artery, 7. tension tests of long nerves of the upper kk, 8. DASH Upper Limb Disability Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands on | Active comparator | Other: Manual TherapyPatients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer. |
| Hands off | No intervention | –Patients with shoulder impingement syndrome. Age 18-50 years. Shoulder pain lasting from 3 months to 1 year, No surgery and injection intervention in the shoulder joint and surrounding area in the history of the disease. - Ailments in scales I and II according to Neer. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-5 0 years,
Key exclusion criteria (5 listed)
- surgical procedures and other surgical interventions
- features of the total rupture of the rotator cuff muscle- III⁰ according to Neer scale, confirmed in imaging studies.
- age under 25 or over 50 years
- diagnosed in ultrasound or MRI with complete damage to the muscles of the rotator cuff,
- the duration of the ailment is up to 3 months or more than 1 year.
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 |
|---|---|---|
| Manual TherapyManual Therapy according to Kaltenborn Evjenth method. Exercises with PT resistance, massage. | Other | Hands on |
Primary outcome
Ultrasound examination
Time frame: 3 month of observation
The measurement will be carried out on one ultrasound device. In all patients, a measurement of the subscapular space of the shoulder joint in the ultrasound image will be performed. Ultrasound examinations are used in the diagnosis of the shoulder joint to assess the thickness and quality of tendons and recognized them. Examinations will take place in the positions: of the suspended upper limb and in the position of visit and external rotation in the shoulder joint. Putting on the Power Doppler mesh will allow you to exclude visible inflammation of the examined area while excluding ongoing acute inflammation. In case of doubt or when the examination shows acute inflammation, the patient will be referred to a doctor and a specialist. The measurement will be carried out on one ultrasound device - Siemens Acuson X150, 10-5 MHz linear fisheries. , by one experienced physiotherapist in accordance with the guidelines
Neer test
Time frame: 3 month of observation
Performing the test: the subject sits sideways to the examiner, the upper c. of the subject with a bent elbow joint and a bent and brought shoulder joint. The examiner resists the subject's elbow from above, who slightly presses his elbow on the investigator's hand. Results: + pain appears in the test position or after pressure, - no pain, +/- the subject is not able to assess the pain
Palpation.
Time frame: 3 month of observation
The examination is carried out in a sitting position with the upper limb suspended.
Shoulder joint mobility according to FMS
Time frame: 3 month of observation
The test evaluates the bilateral mobility of the entire shoulder girdle. The test evaluates the bilateral mobility of the entire shoulder girdle, combining internal rotation with arrival and external rotation with visitation. Proper mobility also requires mobility in the shoulder-scapular joint and in the thoracic spine.
Cross-body abduction stress test
Time frame: 3 month of observation
The subject sits with a limb bent to 90⁰ in the shoulder and elbow joint. Performs the movement of horizontal attachment in the shoulder joint
The numerical scale of pain level 0-10
Time frame: 3 month of observation
The patient is asked to determine the level of pain on a scale of 0-10. The subject is asked to determine the level of pain on a scale of 0-10, in which it is determined how severe the pain is, indicating the appropriate digit on a scale from 0 to 10, where 0 corresponds - "I do not feel pain at all", - 10 - "the worst pain I can imagine"
Assessment of pulse on the radial artery
Time frame: 3 month of observation
Examination is performed to exclude the syndrome stealing of the subclavian artery
DASH Questionnaire
Time frame: 3 month of observation
The questionnaire is concerning upper limb disability. The subject assesses his ability to perform the following actions last week by outlining the number of the most accurate answer in Table 1. The subject then assesses the severity of symptoms last week by outlining the number in Table 2 of the most accurate answer. After completing the test, we count the sum of points. DASH Limitations and Symptoms Index = -1)]×25 where: n = numbers of the answers given. If more than three questions are left unanswered, the DASH cannot be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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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.
Andrzej Kepczynski study director
Klinika Ruchu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Subacromial Impingement Syndrome, run by Klinika Ruchu at 1 site in Poland.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Kepczynski (+48663663383, andrzej.kepczynski@klinikaruchu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound examination (time frame: 3 month of observation). The study lists 8 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 Sep 2022.