Rheumatoid ArthritisNCT05054920
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
A study testing concentric exercises, eccentric exercises and Stretching in people with Rheumatoid Arthritis and Rotator Cuff Tendinosis, run by Cairo University at 1 site in Egypt.
Trial summary
Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with Rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rheumatoid Arthritis, Rotator Cuff Tendinosis, Tendinopathy
- What is being tested?
- concentric exercises, eccentric exercises and Stretching
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2021to 1 Sep 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients diagnosed with RA according to 2010 (American College of Rheumatology)(ACR)/European League Against Rheumatism (EULAR) Classification Criteria for RA
- Patients diagnosed with rotator cuff tendinopathy based on clinical and musculoskeletal Ultrasonography (MSUS) finding.
- Patient complaining of shoulder pain for at least 3 months
- Positive jobs test or hornblower sign or left off test
- Age ranged from 18 to 50 years.
Who cannot join
- Patient indicated for surgical repair of rotator cuff
- Patient with previous shoulder surgery.
- Patient with history of intra-articular shoulder fracture.
- Patient with history of shoulder dislocation
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with Rheumatoid arthritis (RA).
Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.
Patients will be randomly assigned into either concentric or eccentric exercise group. Randomizations will be done using computer random generated numbers.
Read the detailed description
Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with RA. Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.
Patients will be randomizations using computer random generated numbers. patients will receive either eccentric or concentric exercises for internal, external rotators and abductors muscles All patient will do stretching for posterior capsule and pectoralis minor Tendon biological changes and subacromial space will be assessed using musculoskeletal ultrasonography Shoulder function will be assessed using SPADI (shoulder pain and disability index Pain will be assessed using Visual Analogue Scale (VAS) Rheumatoid arthritis disease activity will be assessed using Disease Activity Score-28 for Rheumatoid Arthritis with erythrocyte sedimentation rate (DAS 28 ESR) patient will be assessed at base-line and after finishing of the study
- Conditions
- Rheumatoid Arthritis, Rotator Cuff Tendinosis, Tendinopathy
- Being tested
- concentric exercises, eccentric exercises, Stretching
- Medical subject headings
- Arthritis, Rheumatoid, Rotator Cuff Injuries, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentric exercisesOther
concentric exercises for rotator cuff. internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients
eccentric exercisesOther
Eccentric exercises exercises for rotator cuff internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients
StretchingOther
stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times
| Study group | Role | What they receive |
|---|---|---|
| Concentric exercises group | Experimental | patient will do Concentric exercises. Patients will receive 3 sessions per week for 4 weeks. Exercise will be done under the supervision of the same physical therapist. During each session.
Exercise will be in the form of glenohumeral scaption, internal and external rotation exercises.
patient will also do stretching for posterior capsule and pectoralis minor Receives: Other: concentric exercises; Other: Stretching |
| Eccentric exercises group | Experimental | patient will do eccentric exercises. Patients will receive 3 sessions per week for 4 weeks. Exercise will be done under the supervision of the same physical therapist during each session.
Exercise will be in the form of glenohumeral scaption, internal and external rotation exercises.
patient will also do stretching for posterior capsule and pectoralis minor Receives: Other: eccentric exercises; Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function
shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.
Measured: one month
Secondary outcomes (5)
tendon thickness, fibrillar pattern and echogenicity
tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography
Measured: one month
subacromial space
shoulder subacromial space as measured by Ultrasonography
Measured: one month
Pain measured by Visual analogue scale (VAS)
pain as measured by Visual analogue scale which a 10 cm scale marked at the beginning zero indicating no pain and 10 at the end indicating worst pain
Measured: one month
ESR
Erythrocyte sedimentation rate
Measured: one month
disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)
disease activity score 28 Erythrocyte sedimentation rate High disease activity is defined as a DAS 28 ESR>5.1, moderate activity as a DAS 28 ESR between 3.2 and ≤5.1, low activity as a DAS 28 ESR between 3.2 and >2.6, and remission as a DAS 28 ESR less than 2.6
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start30 Sep 2021
- Primary completion1 Apr 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Badr University
- Responsible party
- Principal investigator, Mina Magdy Wahba, Badr University
- Investigators
- Mohammed Shawki Abdelsalam, PhD, Study chair, Assistance Professor,Faculty of Physical Therapy Cairo UniversityMona Fagaal, PhD, Study director, Assistance Professor, Faculty of Physical Therapy Badr University in CairoMohammed Moustafa Aldosouki Hegazy, PhD, Study director, Lecturer,Faculty of Physical Therapy Cairo UniversityRasmia Mohamed Hassan ElGohry, phD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054920
- Sponsor's protocol ID
- Mina
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05054920
- Acronym / sponsor ID
- Mina
- Conditions
- Rheumatoid Arthritis, Rotator Cuff Tendinosis, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Badr University
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Sep 2021 (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.
Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with Rheumatoid arthritis (RA).
Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.
Patients will be randomly assigned into either concentric or eccentric exercise group. Randomizations will be done using computer random generated numbers.
Detailed description
Study aiming at determining the efficacy of eccentric versus concentric exercises for improving tendon biological characteristics, pain, and shoulder overall function for rotator cuff tendinopathy in patients with RA. Moreover, investigation the relationship between RA activity and the severity of rotator cuff tendinopathy.
Patients will be randomizations using computer random generated numbers. patients will receive either eccentric or concentric exercises for internal, external rotators and abductors muscles All patient will do stretching for posterior capsule and pectoralis minor Tendon biological changes and subacromial space will be assessed using musculoskeletal ultrasonography Shoulder function will be assessed using SPADI (shoulder pain and disability index Pain will be assessed using Visual Analogue Scale (VAS) Rheumatoid arthritis disease activity will be assessed using Disease Activity Score-28 for Rheumatoid Arthritis with erythrocyte sedimentation rate (DAS 28 ESR) patient will be assessed at base-line and after finishing of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentric exercises group | Experimental | Other: concentric exercises, Other: Stretchingpatient will do Concentric exercises. Patients will receive 3 sessions per week for 4 weeks. Exercise will be done under the supervision of the same physical therapist. During each session. Exercise will be in the form of glenohumeral scaption, internal and external rotation exercises. patient will also do stretching for posterior capsule and pectoralis minor |
| Eccentric exercises group | Experimental | Other: eccentric exercises, Other: Stretchingpatient will do eccentric exercises. Patients will receive 3 sessions per week for 4 weeks. Exercise will be done under the supervision of the same physical therapist during each session. Exercise will be in the form of glenohumeral scaption, internal and external rotation exercises. patient will also do stretching for posterior capsule and pectoralis minor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients diagnosed with RA according to 2010 (American College of Rheumatology)(ACR)/European League Against Rheumatism (EULAR) Classification Criteria for RA
- Patients diagnosed with rotator cuff tendinopathy based on clinical and musculoskeletal Ultrasonography (MSUS) finding.
- Patient complaining of shoulder pain for at least 3 months
- Positive jobs test or hornblower sign or left off test
- Age ranged from 18 to 50 years.
Key exclusion criteria (5 listed)
- Patient indicated for surgical repair of rotator cuff
- Patient with previous shoulder surgery.
- Patient with history of intra-articular shoulder fracture.
- Patient with history of shoulder dislocation
- Diabetes mellitus
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 |
|---|---|---|
| concentric exercisesconcentric exercises for rotator cuff. internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients | Other | Concentric exercises group |
| eccentric exercisesEccentric exercises exercises for rotator cuff internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients | Other | Eccentric exercises group |
| Stretchingstretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times | Other | Concentric exercises group, Eccentric exercises group |
Primary outcome
Shoulder function
Time frame: one month
shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.
5 secondary outcomes
tendon thickness, fibrillar pattern and echogenicity
Time frame: one month
subacromial space
Time frame: one month
Pain measured by Visual analogue scale (VAS)
Time frame: one month
ESR
Time frame: one month
disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)
Time frame: one month
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 6 Sep 2023.
- 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.
Mohammed Shawki Abdelsalam, PhD study chair
Assistance Professor,Faculty of Physical Therapy Cairo University
Mona Fagaal, PhD study director
Assistance Professor, Faculty of Physical Therapy Badr University in Cairo
Mohammed Moustafa Aldosouki Hegazy, PhD study director
Lecturer,Faculty of Physical Therapy 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 concentric exercises, eccentric exercises and Stretching in people with Rheumatoid Arthritis and Rotator Cuff Tendinosis, 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 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: finished, as of the sponsor's last update on 6 Sep 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?
Shoulder function (time frame: one month). 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 6 Sep 2023.