NCT05054920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 6, 2023

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

September 19, 2021

Last Update Submit

September 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Shoulder function

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

    one month

Secondary Outcomes (5)

  • tendon thickness, fibrillar pattern and echogenicity

    one month

  • subacromial space

    one month

  • Pain measured by Visual analogue scale (VAS)

    one month

  • ESR

    one month

  • disease activity score 28 Erythrocyte sedimentation rate (DAS 28- ESR)

    one month

Study Arms (2)

Concentric exercises group

EXPERIMENTAL

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 exercisesOther: Stretching

Eccentric exercises group

EXPERIMENTAL

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: eccentric exercisesOther: Stretching

Interventions

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

Concentric exercises group

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

Eccentric exercises group

stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times

Concentric exercises groupEccentric exercises group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University in Cairo (BUC)

Cairo, 12311, Egypt

Location

MeSH Terms

Conditions

Arthritis, RheumatoidRotator Cuff InjuriesTendinopathy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRuptureWounds and InjuriesShoulder InjuriesTendon InjuriesMuscular Diseases

Study Officials

  • Mohammed Shawki Abdelsalam, PhD

    Assistance Professor,Faculty of Physical Therapy Cairo University

    STUDY CHAIR
  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 19, 2021

First Posted

September 23, 2021

Study Start

September 30, 2021

Primary Completion

April 1, 2022

Study Completion

September 1, 2022

Last Updated

September 6, 2023

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations