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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054920
• Other study ID #: Mina
• Status: Completed
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Tendinopathy

Intervention

Other:
• concentric exercises
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
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
stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times

Locations

Country	Name	City	State
Egypt	Badr University in Cairo (BUC)	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function	shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.	one month
Secondary	tendon thickness, fibrillar pattern and echogenicity	tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography	one month
Secondary	subacromial space	shoulder subacromial space as measured by Ultrasonography	one month
Secondary	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	one month
Secondary	ESR	Erythrocyte sedimentation rate	one month
Secondary	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	one month