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Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear

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ClinicalTrials.gov Identifier: NCT03962231
Recruitment Status : Suspended (Coronavirus)
First Posted : May 23, 2019
Last Update Posted : November 9, 2020
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Larissa Pechincha Ribeiro, Universidade Federal de Sao Carlos

Brief Summary:
Introduction: Atraumatic and degenerative rotator cuff tears are common in individuals over 55 years of age. This condition can have a high impact on social life and is associated with chronic pain, weakness and dysfunction of the upper limb. There is evidence that conservative approaches should be the first treatment option. Conservative treatment usually addresses a variety of therapeutic behaviors without providing scientific arguments for the choice and progression of exercises. At that, there is a gap in the literature on the best exercises for this population, whether they are exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with rotator cuff unload exercise program. Objective: To compare the effects of two different exercise programs based on the load of the rotator cuff on a population with shoulder pain and rotator cuff tear. Methods: This is a controlled, randomized, blinded clinical trial. In this study 78 individuals with shoulder pain and presence of atraumatic rupture of the rotator cuff muscle tendon will participate and will be randomly distributed between two groups. The primary outcome will be quality of life (WORC index), and secondary outcomes will include pain, function (DASH), fear avoidance beliefs (FABQ-Brazil), kinesiophobia (Tampa Scale), pain catastrophizing scale, muscle strength of abductors, lateral and medial rotators of the shoulder, range of motion of arm elevation and patient satisfaction. All outcomes will be measured before and after 12 weeks of treatment (2x/week), and 1 month after the end of treatment. The normality of the data will be verified by the Kolmogorov Smirnov test. The differences between the groups will be verified using the mixed linear models with the terms of interaction versus time. The effect size will be calculated for the variables between the groups. The level of significance will be 5%.

Condition or disease Intervention/treatment Phase
Shoulder Pain Rotator Cuff Injuries Rehabilitation Other: Rotator Cuff Unloading Exercise Program Other: Rotator Cuff Loading Exercise Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Rotator Cuff Unloading Versus Loading Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear: a Randomized Clinical Trial
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rotator Cuff Unloading Exercise Program
Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid re-education exercises, assisted arm elevation and scapula control exercises.
Other: Rotator Cuff Unloading Exercise Program
Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid reeducation exercises, assisted arm elevation and scapular control exercises.

Active Comparator: Rotator Cuff Loading Exercise Program
Patients in this group will perform conventional exercises with focus on lateral rotation, medial rotation and arm elevation.
Other: Rotator Cuff Loading Exercise Program
Patients in this group will perform conventional exercises focusing on lateral rotation, medial rotation and arm elevation.




Primary Outcome Measures :
  1. Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The Western Ontario Rotator Cuff Index (WORC) contains 21 questions distributed in five domains, each question can be scored between 0 and 100 on the Analogic visual scale. The final result of WORC varies from 0 to 2100, higher value indicates worse the quality of life of the individual.


Secondary Outcome Measures :
  1. Change from Baseline Shoulder Pain at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).

  2. Change from Baseline Upper Limb Function at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The Function will be measured with Disabilities of the Arm, Shoulder and Hand with scores ranging from 0 to 100 (higher score reflects greater disability)

  3. Change from Baseline Fear Avoidance Beliefs at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The Fear-Avoidance Beliefs Questionnaire (FABQ) contains 2 scales: FABQ work scale (with range from 0 to 42) and FABQ physical activity scale (with range from 0 to 24). Higher scores indicate higher levels of fear-avoidance beliefs.

  4. Change from Baseline Kinesiophobia at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The Kinesiophobia will be measured with Tampa Scale of Kinesiophobia (TKS) with scores ranging from 17 to 68. Higher scores indicate higher degree of kinesiophobia.

  5. Change from Baseline Pain Catastrophizing at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The Pain Catastrophizing Scale is self-administered and contains 13 items. Scale scores range from 0 to 52, with higher values indicating a higher degree of catastrophic thoughts.

  6. Change from Baseline Muscle Strength at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The abductors, lateral and medial rotators of the arm will be tested using handheld dynamometer.

  7. Change from Baseline Range of Motion at 12 weeks and 1 month (follow-up) [ Time Frame: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up) ]
    The maximum range of motion during arm elevation, the range of onset and end of pain in the sagittal and scapular planes will be recorded using a digital inclinometer.

  8. Change from Baseline self-perception of improvement at 12 weeks and 1 month (follow-up) [ Time Frame: Post treatment (12 weeks) and after 1 month (follow-up) ]
    The Overall improvement of Symptoms will be measured with the Global Rating of Change Scale with scores ranging from -7 to +7 (A higher score indicates higher recovery from the condition).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 55 years or over;
  • shoulder pain;
  • at least 90° of arm elevation;
  • atraumatic rotator cuff tear.

Exclusion Criteria:

  • Individuals with a history of trauma associated with onset of symptoms;
  • fracture and/or previous surgery on upper limbs;
  • pain related to the cervical spine;
  • inflammatory arthritis;
  • adhesive capsulitis;
  • cognitive alteration that makes it impossible to perform the questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962231


Locations
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Brazil
Federal University of Sao Carlos
São Carlos, São Paulo, Brazil, 13565-905
Sponsors and Collaborators
Larissa Pechincha Ribeiro
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Larissa P Ribeiro, MD Department of Physical Therapy - Universidade Federal de São Carlos
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Larissa Pechincha Ribeiro, Principal Investigator, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT03962231    
Other Study ID Numbers: UFSCarShoulderLabRC
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: at the end of the study
Access Criteria: At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available. Any researcher can request more information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Larissa Pechincha Ribeiro, Universidade Federal de Sao Carlos:
Treatment
Physiotherapy
Impingement Syndrome
Additional relevant MeSH terms:
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Shoulder Pain
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries