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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Tendinopathy; Rotator Cuff Tendinosis
• Intervention / Treatment: Other: concentric exercises; Other: Stretching; Other: eccentric exercises

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Badr University in Cairo (BUC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concentric exercises group; 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	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; Other: Stretching; stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times
Experimental: Eccentric exercises group; 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	Other: Stretching; stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times; Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tendon thickness, fibrillar pattern and echogenicity	tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography	one month
subacromial space	shoulder subacromial space as measured by Ultrasonography	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	one month
ESR	Erythrocyte sedimentation rate	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	one month

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Badr University
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: September 19, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthritis; Arthritis, Rheumatoid; Rotator Cuff Injuries; Tendinopathy
• Other Study ID Numbers: Mina

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No