Clinical trial NCT05054920: Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
Official title: Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Rotator Cuff Tendinosis
Tendinopathy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Badr University
First posted: 2021-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

1. Adult patients diagnosed with RA according to 2010 (American College of Rheumatology)(ACR)/European League Against Rheumatism (EULAR) Classification Criteria for RA
2. Patients diagnosed with rotator cuff tendinopathy based on clinical and musculoskeletal Ultrasonography (MSUS) finding.
3. Patient complaining of shoulder pain for at least 3 months
4. Positive jobs test or hornblower sign or left off test
5. Age ranged from 18 to 50 years.

Exclusion Criteria:

1. Patient indicated for surgical repair of rotator cuff
2. Patient with previous shoulder surgery.
3. Patient with history of intra-articular shoulder fracture.
4. Patient with history of shoulder dislocation
5. Diabetes mellitus

Primary outcomes:
measure: Shoulder function
timeFrame: one month
Secondary outcomes:
measure: tendon thickness, fibrillar pattern and echogenicity
timeFrame: one month
measure: subacromial space
timeFrame: one month
measure: Pain measured by Visual analogue scale (VAS)
timeFrame: one month
measure: ESR
timeFrame: one month
measure: disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University in Cairo (BUC)
Study officials:
affiliation: Assistance Professor,Faculty of Physical Therapy Cairo University
name: Mohammed Shawki Abdelsalam, PhD
role: STUDY_CHAIR
affiliation: Assistance Professor, Faculty of Physical Therapy Badr University in Cairo
name: Mona Fagaal, PhD
role: STUDY_DIRECTOR
affiliation: Lecturer,Faculty of Physical Therapy Cairo University
name: Mohammed Moustafa Aldosouki Hegazy, PhD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Rasmia Mohamed Hassan ElGohry, phD
role: STUDY_DIRECTOR
References: