Shoulder Impingement SyndromeNCT05950880
Effect of High Intensity Exercises in Treatment of Patients With Shoulder Impingement Syndrome
A study testing High intensity shoulder exercise and Conventional physical therapy in people with Shoulder Impingement Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Purposes of the study To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- High intensity shoulder exercise and Conventional physical therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 25 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Athletic patients
- Age of the patients between 18 - 35 years
- Unilateral shoulder pain more than 3 months.
- Positive Hawkins test.
- Positive empty or full cane test.
- Pain at night or incapable of lying on the shoulder.
Show all 10Show fewer
- Pain with active shoulder elevation in the scapular plane.
- History of pain in the C5-C6 dermatome.
- Pain with palpation of the rotator cuff tendons.
- The patient had pain with resisted isometric abduction
Who cannot join
- History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation).
- Clinical sign of cervical radiculopathy.
- History of acromio -clavicular pain.
- Rheumatoid Arthritis.
- Adhesive capsulitis.
- Tumors
Show all 9Show fewer
- Labrum lesions
- Capsular or ligamentous tears or avulsions
- Cartilage lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding High Intensity Exercises to Conventional Physical Therapy in Treatment of Athlete Patients With Shoulder Impingement Syndrome
Purposes of the study
To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome
Read the detailed description
Patients will be randomized into either High-intensity shoulder exercise group or Conventional physical therapy group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- High intensity shoulder exercise, Conventional physical therapy
- 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.
High intensity shoulder exerciseOther
Exercises that target the rotator cuff muscles using 90% of one repetition maximum only for 5 repetitions
Conventional physical therapyOther
Conventional physical therapy consisting of scapular stabilization exercises, posterior capsule stretch, and rotator cuff activation exercises
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise + Conventional physical therapy | Experimental | Patients in this group will receive High-intensity exercise + Conventional physical therapy Receives: Other: High intensity shoulder exercise; Other: Conventional physical therapy |
| Conventional physical therapy | Active comparator | Patients in this group will receive Conventional physical therapy Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain and function
Shoulder pain and disability index (SPADI)
Measured: Change from Baseline pain and function at 6 weaks
Supraspinatus muscle thickness
Diagnostic Ultrasound
Measured: Change from Baseline Supraspinatus muscle thickness at 6 weaks
Secondary outcomes (4)
Sub acromial space (Acromiohumeral distance).
Diagnostic Ultrasound
Measured: Change from Baseline Sub acromial space at 6 weaks
External and internal rotators muscle strength.
Hand-held dynamometer
Measured: Change from Baseline External and internal rotators muscle strength at 6 weaks
supuraspinatus muscle strength
Hand-held dynamometer
Measured: Change from Baseline supuraspinatus muscle strength at 6 weaks
shoulder performance
Timed push up test
Measured: Change from Baseline shoulder performance at 6 weaks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jan 2023
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Gamiel Ayed, Cairo University
- Investigators
- Abdallah Gamiel, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950880
- Sponsor's protocol ID
- P.T.REC/012/004361
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding High Intensity Exercises to Conventional Physical Therapy in Treatment of Athlete Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05950880
- Acronym / sponsor ID
- P.T.REC/012/004361
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 18 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.
Purposes of the study
To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome
Detailed description
Patients will be randomized into either High-intensity shoulder exercise group or Conventional physical therapy group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise + Conventional physical therapy | Experimental | Other: High intensity shoulder exercise, Other: Conventional physical therapyPatients in this group will receive High-intensity exercise + Conventional physical therapy |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapyPatients in this group will receive Conventional physical therapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Athletic patients
- Age of the patients between 18 - 35 years
- Unilateral shoulder pain more than 3 months.
- Positive Hawkins test.
- Positive empty or full cane test.
Key exclusion criteria (9 listed)
- History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation).
- Clinical sign of cervical radiculopathy.
- History of acromio -clavicular pain.
- Rheumatoid Arthritis.
- Adhesive capsulitis.
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 |
|---|---|---|
| High intensity shoulder exerciseExercises that target the rotator cuff muscles using 90% of one repetition maximum only for 5 repetitions | Other | High intensity exercise + Conventional physical therapy |
| Conventional physical therapyConventional physical therapy consisting of scapular stabilization exercises, posterior capsule stretch, and rotator cuff activation exercises | Other | Conventional physical therapy, High intensity exercise + Conventional physical therapy |
Primary outcome
pain and function
Time frame: Change from Baseline pain and function at 6 weaks
Shoulder pain and disability index (SPADI)
Supraspinatus muscle thickness
Time frame: Change from Baseline Supraspinatus muscle thickness at 6 weaks
Diagnostic Ultrasound
4 secondary outcomes
Sub acromial space (Acromiohumeral distance).
Time frame: Change from Baseline Sub acromial space at 6 weaks
External and internal rotators muscle strength.
Time frame: Change from Baseline External and internal rotators muscle strength at 6 weaks
supuraspinatus muscle strength
Time frame: Change from Baseline supuraspinatus muscle strength at 6 weaks
shoulder performance
Time frame: Change from Baseline shoulder performance at 6 weaks
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 1 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Shoulder Impingement Syndrome
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
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.
Abdallah Gamiel, MSc 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 High intensity shoulder exercise and Conventional physical therapy in people with Shoulder 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 10 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 1 Apr 2024. 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?
pain and function (time frame: Change from Baseline pain and function at 6 weaks). 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?
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 1 Apr 2024.