Specific exercise program versus home exercises in patients with subacromial shock syndrome

• Register: REBEC
• Last refreshed on: 22 August 2023
• Main ID: RBR-6cch82
• Date of registration: 05/01/2018
• Prospective Registration: No
• Primary sponsor: Universidad de las Americas
• Public title: Specific exercise program versus home exercises in patients with subacromial shock syndrome
• Scientific title: Specific exercise program versus home exercise in patients with subacromial shock syndrome: a randomized clinical trial
• Date of first enrolment: 30/09/2017
• Recruitment status: Recruitment completed
• URL: https://ensaiosclinicos.gov.br/rg/RBR-6cch82
• Study type: Intervention
• Study design: Clinical trial of treatment, randomized-controlled, parallel, single blind, two-arm
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Felipe Araya Quintanilla
• Affiliation: Universidad de las Americas

• Name: Felipe Araya Quintanilla
• Affiliation: Universidad de las Americas

Key inclusion & exclusion criteria

Inclusion criteria: Subjects with more than 18 years of age derived from the Trauma Service of Adults with clinical diagnosis and image of SPSA type II with a poor initial response of conservative treatment. Volunteers who Accept and sign informed consent.
Exclusion criteria: subjects presenting pathologies of cervical origin (cervicobrachialgia, herniated disc, etc.); other pathologies of the joint complex of the shoulder (proximal humerus fracture, calcific tendinitis, adhesive capsulitis, glenohumeral instability, partial or total rupture of the rotator cuff, etc.) ; who also present antecedents of previous surgery of the affected shoulder and who have previously been infiltrated with corticosteroids in the affected shoulder (6 months).

Age minimum: 18Y
Age maximum: 50Y
Gender: -

Health Condition(s) or Problem(s) studied

Subacromial impingement syndrome

Intervention(s)

Participants will be assigned to an alphanumeric code list and randomized (1:1 ratio) using SPSS v27 to receive an experimental or control group. The experimental group, will have 47 participants will receive a specific exercise program based on motor training, taking as a reference the clinical decision algorithm proposed by Klintberg et al. It will begin with a conscious muscle control exercise to improve proprioception and normalize the position of scapular rest and Glenohumeral Then, three scapular control exercises are continued and finally two glenohumeral control exercises are prescribed to restore centralization and prevent superior translation of the humeral head. The general principles of the program are; the exercises should not reproduce pain, only mild to moderate pain levels (<4/10 in EVA) are accepted after the session, but must have stopped within 12 hours and a maximum of 4 exercises per session. There will be 2 to 3 weekly sessions for 12 weeks.
In the control group, will have 47 participants, all patients will attend a visit with a physiotherapist, where they will receive information about their clinical condition and will be provided with a printed document with a program of non-specific exercises to perform at home, this consists of six exercises without external load for the shoulder and cervical spine; shoulder abduction movements in the frontal plane, shoulder retraction, elevation of the shoulder, retraction of the cervical spine, passive stretching of the upper trapezius and pectoralis major and minor.This will be done twice a day for 12 weeks. To monitor adherence to treatment, patients will be contacted by telephone at the 4th and 8th week of treatment. Neither the participants nor the therapist responsible for the treatments will be bl

Primary Outcome(s)

Expected result 1- It is expected to find a improve in shoulder function assessed through the Constant-Murley in the participants of the specific exercise program compared to that of home exercises

The function will be evaluated using the Constant-Murley questionnaire, which is one of the most widely used and recommended instruments for assessing shoulder function. taking into account the study of Henseler et al, we established as a clinically important minimum difference a difference of at least 17 points for the group treated with the specific exercise program. To detect this difference between both treatments, with a value of = 0.05 (probability of committing a type I error) and a statistical power of 90%, a minimum of 39 patients per group is required. We considered adjusting the sample size for possible losses or dropouts, increasing the number of patients recruited by 20%, with 47 patients remaining in each group. According to this, the authors of the present study have proposed as an experimental hypothesis that there is an increase of at least 17 points in the Constant-Murley questionnaire in the group treated with a specific exercise program compared to that of home exercises.

Secondary Outcome(s)

Expected result 2- It is expected to find a improve in upper limb function assessed through the Disabilities of the arm, shoulder and hand (dash) questionnaire in the participants of the specific exercise program compared to that of home exercises

Expected result 3- It is expected to find a decrease in pain intensity assessed through the visual analogue scale (VAS) in the participants of the specific exercise program compared to that of general exercises

Source(s) of Monetary Support

Universidad de las Americas

Secondary Sponsor(s)

Universidad de las Americas

Ethics review

Status: Approved
Approval date: 15/02/2016
Contact:

[e-mail]

Comité de Ética em Pesquisa

[phone]

[e-mail]

Results

• Results available: Yes
• Date Completed: 09/01/2023