Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome

August 15, 2019 updated by: Anamaria Siriani de Oliveira, University of Sao Paulo

Effect of Scapula-focused Treatment With Additional Motor Control Exercises on Pain and Disability in Patients With Subacromial Pain Syndrome: A Randomized Controlled Trial

This study evaluate the effectiveness of adding neuromuscular exercises with tactile, visual and auditory feedback to a scapula-focused treatment, both emphasizing the periscapular muscles on improvement of disability in patients with subacromial pain syndrome compared to patients receiving only strengthening exercise protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evidence of the effectiveness conservative treatments in shoulder impingement are in favor the application of specific exercises for scapulothoracic muscles and rotator cuff on pain reduction and improvement of upper limb function, supervised or performed at home, and these same exercises associated with other therapies promote a greater reduction in pain and improvement in disability.

Currently, the evidence of better methodological quality present in the literature13 points out that the performance of motor control exercises focused on the scapula associated with mobilization and stretching generate pain improvement and clinically relevant improvement of the function. The few studies in this area have great methodological diversity with significant limitations. The hypothesis is that patients with subacromial pain syndrome who will receive traditional exercise protocol with the addition of neuromuscular training will show less functional disability, a greater reduction in pain intensity, increase muscle strength and range of motion when compared to the patient group that will receive only the protocol without neuromuscular training, immediately after the intervention, four and eight weeks and four months after randomization and that these benefits are clinically relevant.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • University of São Paulo, Ribeirão Preto Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of subacromial pain syndrome with confirmed positivity in at least three of the five specific orthopedic impact tests: Neer test, Hawkins- Kennedy test, painful arc, external rotation resistance and empty can. Present history of pain in the shoulder lasting more than a week located in the proximal area of the shoulder

Exclusion Criteria:

  • Subjects with a history of trauma or shoulder surgery, total rupture of the rotator cuff tendon and biceps, physically active involving the upper limbs or considered active accordance with the short version International Physical Activity Questionnaire (IPAQ). Subjects who have neurological diseases, referred pain in arms (indicative of involvement in the cervical or thoracic region), systemic disease involving the joints such as rheumatoid arthritis or fibromyalgia, the presence of disorders in the wrist such as carpal tunnel syndrome, and have done physical therapy in the shoulder the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Scapula-focused exercises
Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions
Other: Scapula-focused exercises
Experimental: Motor control exercises
Towel slide, Scapular Clock, PNF scapular, Inferior Glide modified, Scapular Orientation Exercise, protraction and retraction of scapula, three times a week, 8 weeks, 3x10 repetitions
Other: Scapula-focused exercises
Other: Motor control exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functionality Evaluated With Specific Questionnaire
Time Frame: baseline, four and eight weeks and sixteen weeks after randomization
The Brazilian version of Shoulder Pain and Disability Index ranging 0 to 100 points. Lower scores indicate better functionality
baseline, four and eight weeks and sixteen weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intensity of Pain Evaluated by a Scale
Time Frame: baseline, four and eight weeks and sixteen weeks after randomization
Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain
baseline, four and eight weeks and sixteen weeks after randomization
Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF)
Time Frame: baseline, four and eight weeks and sixteen weeks after randomization
Strength of serratus anterior, trapezius muscles, abduction, adduction, internal and external rotation movements the arm with hand held Dynamometer.
baseline, four and eight weeks and sixteen weeks after randomization
Perceived Change Evaluated by Numerical Scale
Time Frame: four, eight weeks and sixteen weeks of randomization
Global Perceived Effect Scale ranging -5 to +5 points. Positive values indicate improvement and negative values indicate worsening of symptoms
four, eight weeks and sixteen weeks of randomization
Change in Kinesiophobia Evaluated With Specific Questionnaire
Time Frame: baseline, four and eight weeks and sixteen weeks after randomization
Tampa Scale of Kinesiophobia ranging 17 to 68 points. High scores indicate high degree kinesiophobia
baseline, four and eight weeks and sixteen weeks after randomization
Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees
Time Frame: baseline, four and eight weeks and sixteen weeks after randomization
abduction, adduction, internal and external rotation of the shoulder
baseline, four and eight weeks and sixteen weeks after randomization
Satisfaction With Treatment Evaluated With Specific Questionnaire
Time Frame: four, eight weeks and sixteen weeks after randomization
Medrisk Questionnaire ranging 13 to 80 points. High scores indicate satisfaction with treatment
four, eight weeks and sixteen weeks after randomization
Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees
Time Frame: baseline, four and eight weeks and sixteen weeks after randomization
upward rotation and tilt of the scapula
baseline, four and eight weeks and sixteen weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Gisele H Hotta, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1179-1921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication of data in the form of article:12/2018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shoulder Impingement Syndrome

Clinical Trials on Scapula-focused exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe