Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Tendinopathy; Rheumatoid Arthritis; Rotator Cuff Tendinosis
• Interventions: Other: concentric exercises; Other: eccentric exercises; Other: Stretching

• Registration Number: NCT05054920
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-19
• Study First Posted: 2021-09-23
• Study Start: 2021-09-30
• Status Verified: 2021-10
• Primary Completion: 2022-04-01
• Study Completion: 2022-09-01
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentric exercises group	concentric exercises	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
Eccentric exercises group	Stretching	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
Concentric exercises group	Stretching	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
Eccentric exercises group	eccentric exercises	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

Primary Outcome Measures

Name	Time	Method
Shoulder function	one month	shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.

Secondary Outcome Measures

Name	Time	Method
disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)	one month	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
subacromial space	one month	shoulder subacromial space as measured by Ultrasonography
ESR	one month	Erythrocyte sedimentation rate
tendon thickness, fibrillar pattern and echogenicity	one month	tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography
Pain measured by Visual analogue scale (VAS)	one month	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

Trial Locations

Locations (1)

Badr University in Cairo (BUC); 🇪🇬 Cairo, Egypt