Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear

NCT03962231 | Unknown DMC

• 1 other identifier: UFSCarShoulderLabRC
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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%.

Conditions

Shoulder Pain; Rotator Cuff Injuries; Rehabilitation

Keywords

Treatment; Physiotherapy; Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC)

  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.

  Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)

Secondary Outcomes (8)

• Change from Baseline Shoulder Pain at 12 weeks and 1 month (follow-up)

  Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)

• Change from Baseline Upper Limb Function at 12 weeks and 1 month (follow-up)

  Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)

• Change from Baseline Fear Avoidance Beliefs at 12 weeks and 1 month (follow-up)

  Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)

• Change from Baseline Kinesiophobia at 12 weeks and 1 month (follow-up)

  Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)

• Change from Baseline Pain Catastrophizing at 12 weeks and 1 month (follow-up)

  Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)

Study Arms (2)

Rotator Cuff Unloading Exercise Program

ACTIVE COMPARATOR

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

Rotator Cuff Loading Exercise Program

ACTIVE COMPARATOR

Patients in this group will perform conventional exercises with focus on lateral rotation, medial rotation and arm elevation.

Other: Rotator Cuff Loading Exercise Program

Interventions

Rotator Cuff Unloading Exercise Program OTHER

Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid reeducation exercises, assisted arm elevation and scapular control exercises.

Rotator Cuff Unloading Exercise Program

Rotator Cuff Loading Exercise Program OTHER

Patients in this group will perform conventional exercises focusing on lateral rotation, medial rotation and arm elevation.

Rotator Cuff Loading Exercise Program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Larissa Pechincha Ribeiro: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Federal University of Sao Carlos

São Carlos, São Paulo, 13565-905, Brazil

RECRUITING

Related Publications (1)

• Ribeiro LP, Cools A, Camargo PR. Rotator cuff unloading versus loading exercise program in the conservative treatment of patients with rotator cuff tear: protocol of a randomised controlled trial. BMJ Open. 2020 Dec 12;10(12):e040820. doi: 10.1136/bmjopen-2020-040820.

  PMID: 33310803 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Larissa P Ribeiro, MD

  Department of Physical Therapy - Universidade Federal de São Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larissa P Ribeiro, MD

CONTACT

55 16 3306 6695; larissapechincha@hotmail.com

Paula R Camargo, PhD

CONTACT

55 16 3306 6696; prcamargo@ufscar.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 23, 2019
• Study Start: August 5, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

BR (1)