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

Primary Purpose

Rheumatoid Arthritis, Rotator Cuff Tendinosis, Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
concentric exercises
eccentric exercises
Stretching
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Badr University in Cairo (BUC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Concentric exercises group

Eccentric exercises group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

tendon thickness, fibrillar pattern and echogenicity
tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography
subacromial space
shoulder subacromial space as measured by Ultrasonography
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
ESR
Erythrocyte sedimentation rate
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

Full Information

First Posted
September 19, 2021
Last Updated
September 3, 2023
Sponsor
Cairo University
Collaborators
Badr University
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1. Study Identification

Unique Protocol Identification Number
NCT05054920
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Badr University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Rotator Cuff Tendinosis, Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concentric exercises group
Arm Type
Experimental
Arm Description
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
Arm Title
Eccentric exercises group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
concentric exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
eccentric exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times
Primary Outcome Measure Information:
Title
Shoulder function
Description
shoulder Pain and Disability Index (SPADI): It is a self-reported questionnaire evaluating the function of the shoulder.
Time Frame
one month
Secondary Outcome Measure Information:
Title
tendon thickness, fibrillar pattern and echogenicity
Description
tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography
Time Frame
one month
Title
subacromial space
Description
shoulder subacromial space as measured by Ultrasonography
Time Frame
one month
Title
Pain measured by Visual analogue scale (VAS)
Description
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
Time Frame
one month
Title
ESR
Description
Erythrocyte sedimentation rate
Time Frame
one month
Title
disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)
Description
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
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Shawki Abdelsalam, PhD
Organizational Affiliation
Assistance Professor,Faculty of Physical Therapy Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona Fagaal, PhD
Organizational Affiliation
Assistance Professor, Faculty of Physical Therapy Badr University in Cairo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammed Moustafa Aldosouki Hegazy, PhD
Organizational Affiliation
Lecturer,Faculty of Physical Therapy Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasmia Mohamed Hassan ElGohry, phD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Badr University in Cairo (BUC)
City
Cairo
ZIP/Postal Code
12311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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