Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
1 other identifier
interventional
40
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Sep 2021
Shorter than P25 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2021
CompletedFirst Posted
Study publicly available on registry
September 23, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedSeptember 6, 2023
October 1, 2021
6 months
September 19, 2021
September 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Shoulder function
shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.
one month
Secondary Outcomes (5)
tendon thickness, fibrillar pattern and echogenicity
one month
subacromial space
one month
Pain measured by Visual analogue scale (VAS)
one month
ESR
one month
disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)
one month
Study Arms (2)
Concentric exercises group
EXPERIMENTALpatient 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
EXPERIMENTALpatient 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
Interventions
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 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
stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Badr Universitycollaborator
Study Sites (1)
Badr University in Cairo (BUC)
Cairo, 12311, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohammed Shawki Abdelsalam, PhD
Assistance Professor,Faculty of Physical Therapy Cairo University
- STUDY DIRECTOR
Mona Fagaal, PhD
Assistance Professor, Faculty of Physical Therapy Badr University in Cairo
- STUDY DIRECTOR
Mohammed Moustafa Aldosouki Hegazy, PhD
Lecturer,Faculty of Physical Therapy Cairo University
- STUDY DIRECTOR
Rasmia Mohamed Hassan ElGohry, phD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
September 19, 2021
First Posted
September 23, 2021
Study Start
September 30, 2021
Primary Completion
April 1, 2022
Study Completion
September 1, 2022
Last Updated
September 6, 2023
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share