Impingement SyndromeNCT05955820
Suspension System on Impingement Syndrome
A study testing Suspension system and Dumbbells in people with Impingement Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impingement Syndrome
- What is being tested?
- Suspension system and Dumbbells
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2022to 8 Jul 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fifty-eight subjects with SIS (more than three months).
- Their age ranges from 20-45 years old
- Level of pain (at least 2/10 on VAS)
- Body mass index (BMI) between 18-25
- Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test.
Who cannot join
- The subjects will be excluded if they had:
- Received physiotherapy at last 3 months.
- Received corticosteroids injection in subacromial space at last 3 months.
- Received anti-inflammatory medications.
- Have a fracture or dislocation in shoulder, neck and thoracic regions.
- Have an acute rotator cuff tear.
Show all 9Show fewer
- Have tumor or malignancy in shoulder region.
- Have neurologic problems in shoulder, neck and thoracic regions.
- Have cooperation difficulties due to cognitive disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Selected Suspension System Exercise Program on Patients With Subacromial Impingement Syndrome
To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome.
Read the detailed description
Two groups were assigned to this study, the first one received four conventional exercises that designed for shoulder impingement syndrome, the second group received the same four conventional exercises plus four selected suspension system exercises.
The sessions were conducted three times per week fir four weeks.
- Conditions
- Impingement Syndrome
- Being tested
- Suspension system, Dumbbells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension systemDevice
Also called Neurac system
Participants will be tested by four exercises designed for impingement syndrome using the suspension system
DumbbellsDevice
Participants will be tested by four exercises designed for impingement syndrome using Dumbbells
| Study group | Role | What they receive |
|---|---|---|
| Conventional exercises for impingement syndrome | Experimental | Four exercises (prone extension, side-lying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation) will be performed for three sets of 10 repetitions Receives: Device: Dumbbells |
| Suspension system exercises for impingement syndrome | Experimental | Four exercises (Kneeling shoulder extension, Supine/ standing / kneeling row, sitting press up, kneeling push up) will be performed for 3-6 sets of 10 repetitions Receives: Device: Suspension system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in active shoulder ROM
Proprioception will be tested by using inclinometer to determine patient's active shoulder range of motion for internal and external rotation, flexion, and extension
Measured: Baseline
Improvement in functional performance
Assessment of function using SPADI subscale which contains 13 items that assess two domains; a 5-item subscale that measures pain and 8-item subscale that measures disability. In addition, Several non-specific strength/power tests may assist in determining the level of functional performance of the patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start21 Sep 2022
- Primary completion23 Jun 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impingement SyndromeStudies 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
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Mumdouh Yousef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955820
- Sponsor's protocol ID
- Impingement syndrome new EX
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen L, Chen J, Peng Q, Chen J, Zou Y, Liu G. Effect of Sling Exercise Training on Balance in Patients with Stroke: A Meta-Analysis. PLoS One. 2016 Oct 11;11(10):e0163351. doi: 10.1371/journal.pone.0163351. eCollection 2016.
PubMed 27727288
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Selected Suspension System Exercise Program on Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05955820
- Acronym / sponsor ID
- Impingement syndrome new EX
- Conditions
- Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 21 Jul 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.
To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome.
Detailed description
Two groups were assigned to this study, the first one received four conventional exercises that designed for shoulder impingement syndrome, the second group received the same four conventional exercises plus four selected suspension system exercises.
The sessions were conducted three times per week fir four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional exercises for impingement syndrome | Experimental | Device: DumbbellsFour exercises (prone extension, side-lying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation) will be performed for three sets of 10 repetitions |
| Suspension system exercises for impingement syndrome | Experimental | Device: Suspension systemFour exercises (Kneeling shoulder extension, Supine/ standing / kneeling row, sitting press up, kneeling push up) will be performed for 3-6 sets of 10 repetitions |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fifty-eight subjects with SIS (more than three months).
- Their age ranges from 20-45 years old
- Level of pain (at least 2/10 on VAS)
- Body mass index (BMI) between 18-25
- Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test.
Key exclusion criteria (9 listed)
- Received physiotherapy at last 3 months.
- Received corticosteroids injection in subacromial space at last 3 months.
- Received anti-inflammatory medications.
- Have a fracture or dislocation in shoulder, neck and thoracic regions.
- Have an acute rotator cuff tear.
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 |
|---|---|---|
| Suspension systemAlso: Neurac systemParticipants will be tested by four exercises designed for impingement syndrome using the suspension system | Device | Suspension system exercises for impingement syndrome |
| DumbbellsParticipants will be tested by four exercises designed for impingement syndrome using Dumbbells | Device | Conventional exercises for impingement syndrome |
Primary outcome
Improvement in active shoulder ROM
Time frame: Baseline
Proprioception will be tested by using inclinometer to determine patient's active shoulder range of motion for internal and external rotation, flexion, and extension
Improvement in functional performance
Time frame: Baseline
Assessment of function using SPADI subscale which contains 13 items that assess two domains; a 5-item subscale that measures pain and 8-item subscale that measures disability. In addition, Several non-specific strength/power tests may assist in determining the level of functional performance of the patients
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 21 Jul 2023.
- Background: PubMed 27727288Chen L, Chen J, Peng Q, Chen J, Zou Y, Liu G. Effect of Sling Exercise Training on Balance in Patients with Stroke: A Meta-Analysis. PLoS One. 2016 Oct 11;11(10):e0163351. doi: 10.1371/journal.pone.0163351. eCollection 2016.
- 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 Suspension system and Dumbbells in people with Impingement Syndrome, 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 5 inclusion and 9 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 21 Jul 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 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?
Improvement in active shoulder ROM (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05955820, which also lists 1 linked publication.
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 21 Jul 2023.