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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-6wrv5y
Date of registration: 10/04/2018
Prospective Registration: No
Primary sponsor: CDT Hospital San Borja de Arriaran
Public title: Effectiveness of the addition of pectoral stretching in patients with subacromial impingement syndrome: a clinical trial.
Scientific title: Effectiveness of adding pectoralis minor stretches to an exercise program in patients with subacromial impingement syndrome: a randomized clinical trial.
Date of first enrolment: 05/03/2018
Target sample size:
Recruitment status: Data analysis completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-6wrv5y
Study type:  Intervention
Study design:  clinical trial treatment, randomized, controlled, parallel single blind, two arms.

 
Phase:  N/A
Countries of recruitment
Chile
Contacts
Name: Felipe Andres   Araya
Address:  Manuel Montt 948 7500972 Santiago Chile
Telephone: +5697122483
Email: fandres.kine@gmail.com
Affiliation:  Universidad de las Americas
Name: Felipe Andres   Araya
Address:  Manuel Montt 948 7500972 Santiago Chile
Telephone: +5697122483
Email: fandres.kine@gmail.com
Affiliation:  Universidad de las Americas
Key inclusion & exclusion criteria
Inclusion criteria: Included:Patients over 18 years of age referred from the Adult Orthopedist Department with a clinical and imaging diagnosis of SIS type II; Who accepted and signed the informed consent.

Exclusion criteria: Excluded;Patients who presented pathologies of cervical origin cervical such as radiculopathy; or other pathologies of the shoulder joint complex such as osteoarthritis in the acromioclavicular or glenohumeral joints, calcific tendinitis, adhesive capsulitis, glenohumeral instability; partial or full-thickness tear rotator cuff; etc;patients who have had history of acute trauma;previous surgery or previous fracture in the affected shoulder, patients who have had corticoid infiltration in the affected shoulder in the last 12 months.

Age minimum: 18Y
Age maximum: 55Y
Gender: -
Health Condition(s) or Problem(s) studied
subacromial impingement syndrome
C05.550.840
Intervention(s)
E02.779.474
The control group, 40 subjects received a specific exercise program based on the algorithm of clinical decision proposed by Klintberg et al, The program start with conscious control exercises to improve proprioception and normalize the scapular and glenohumeral resting position, continuing with scapular control exercises to improve upward rotation and posterior scapular tilt. Finally, glenohumeral control exercises to restore centralization and prevent the superior translation of the humeral head. The general principles of the program are following; the exercises should not reproduce pain, only mild to moderate pain levels (<4/10 on VAS) are accepted after the session; a maximum of 4 exercises per session; begins with low load / low activation exercises, with the arms below the level of the shoulders, emphasizing the quality of the performance of the motor task, performed slowly, consciously and progressively, and during the course of the program the feedback is gradually diminished, until the realization of exercises subconsciously and automatically. Two weekly sessions over 12 weeks were carried out.
The experimental group, 40 subjects received the same program as the control group, plus a program of stretching exercises using the “unilateral corner stretch”, the protocol consisted of 4 repetitions of 1-minute stretches with a 30 second interval between repetitions. The subjects were instructed by a physiotherapist to perform a unilateral corner stretch using the wall. The starting position for this stretch is with the patient in the standing position, 90º of arm abduction, 90º of the elbow flexion, and the palmar surface on the hand on the wall. The contralateral leg to the shoulder being stretched was positioned in forward of the other leg. To apply the stretch,
Other
Primary Outcome(s)
The function will was evaluated utilizing the Constant-Murley questionnaire, which is one of the most frequently specific instruments used and recommended to evaluate the shoulder function. The Constant-Murley score has a 100-point scoring system that is divided into 4 domains: pain (maximal 15 points), daily life activities (maximal 20 points), painless range of motion (maximal 40 points), and abduction strength evaluation (maximal 25 points) according to the methods described by Constant et al. Despite the inconveniences in the standardization of some of the measurements and the interpretation of the final results, this questionnaire presents a high correlation with other specific scales and questionnaires for the shoulder, showing a high reliability and sensitivity to detect post-intervention changes in a wide variety of shoulder pathologies.

As possible results, we expect there to be significant differences between the CG and EG in the Ffunction, pain and pectoral minor length at the end of treatment for 12 weeks.
When comparing the results between both treatments at the end of the 12th week, the Constant-Murley questionnaire showed a difference of 1.44 points (p = 0.583), and the DASH questionnaire, a difference of 5.41 points (p = 0.002), both differences in favor of the CG
Secondary Outcome(s)
For the VAS at rest the difference was of 0.19 cm (p = 0.107) in favor of the CG. For the VAS at movement was of 0.47 cm (p = 0.082), this difference in pain reduction was also greater in the CG, but it was not statistically significant.
In the case of Pm resting length the difference was 0.27 cm (p = 0.064), and PMI the difference was 0.34% (p = 0.004), both differences in favor of the IG.
Spanish version of the DASH questionnaire will was used to assess function of the upper limb. Scores range from 0 to 100, with higher scores indicating a worse condition.37 This version of the DASH questionnaire has been shown to be reliable, valid and responsive instrument that can provide a standardized measure in Spanish patients with upper-extremity musculoskeletal conditions. A recent study, showed that a decrease of 10 points on the DASH questionnaire can be considered a minimal clinically important difference.
Pain intensity at rest and during activity were assessed with a VAS, with scores ranging from 0 (“no pain”) to 10 (“the worst imaginable pain”). The VAS has been shown to be a reliable and valid instrument to assess changes in pain intensity.Tashjian et al showed that a decrease of 1.4 cm on the VAS can be considered a minimal clinically important difference in patients with rotator cuff disease.
Pm muscle length was defined as the distance between two bony landmarks: the coracoid process and the inferior medial aspect of the 4th rib adjacent to the sternocostal junction.
The assessment was performed with a flexible tape measure, with the patient in standing and relaxed posture with the arms at the side in the neutral position, avoid postural correction, and exhale just before the measurement. Pectoralis minor length index (PMI) was used to normalize our measurements to the participant's height to determine the relative length of pectoralis minor. PMI was calculated by dividing the resting length (cm) by subject height (cm), and multiplying by 100. This method has been shown to be valid and reliable to evaluate the length of the Pm muscle.
Secondary ID(s)
Source(s) of Monetary Support
Universidad de las Americas
Secondary Sponsor(s)
Universidad de las Americas
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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