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NCT Number: NCT05054920

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Rotator Cuff Injuries Rotator Cuff Tendinosis Rupture Shoulder Injuries Skin and Connective Tissue Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Badr University in Cairo (BUC)

Cairo, 12311, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

concentric exercises

Other

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

Other

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

Other

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

Primary outcomes

  1. Shoulder function

    Time frame: one month

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

Secondary outcomes

  1. tendon thickness, fibrillar pattern and echogenicity

    Time frame: one month

    tendon thickness, fibrillar pattern and echogenicity as measured Ultrasonography

  2. subacromial space

    Time frame: one month

    shoulder subacromial space as measured by Ultrasonography

  3. Pain measured by Visual analogue scale (VAS)

    Time frame: 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

  4. ESR

    Time frame: one month

    Erythrocyte sedimentation rate

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Badr University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2021
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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