Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome
Primary Purpose
Shoulder Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Scapula-focused exercises
Motor control exercises
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Rehabilitation, Shoulder
Eligibility Criteria
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.
Sites / Locations
- University of São Paulo, Ribeirão Preto Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Scapula-focused exercises
Motor control exercises
Arm Description
Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions
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
Outcomes
Primary Outcome Measures
Change in Functionality Evaluated With Specific Questionnaire
The Brazilian version of Shoulder Pain and Disability Index ranging 0 to 100 points. Lower scores indicate better functionality
Secondary Outcome Measures
Change in Intensity of Pain Evaluated by a Scale
Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain
Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF)
Strength of serratus anterior, trapezius muscles, abduction, adduction, internal and external rotation movements the arm with hand held Dynamometer.
Perceived Change Evaluated by Numerical Scale
Global Perceived Effect Scale ranging -5 to +5 points. Positive values indicate improvement and negative values indicate worsening of symptoms
Change in Kinesiophobia Evaluated With Specific Questionnaire
Tampa Scale of Kinesiophobia ranging 17 to 68 points. High scores indicate high degree kinesiophobia
Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees
abduction, adduction, internal and external rotation of the shoulder
Satisfaction With Treatment Evaluated With Specific Questionnaire
Medrisk Questionnaire ranging 13 to 80 points. High scores indicate satisfaction with treatment
Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees
upward rotation and tilt of the scapula
Full Information
NCT ID
NCT02695524
First Posted
February 19, 2016
Last Updated
August 15, 2019
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02695524
Brief Title
Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome
Official Title
Effect of Scapula-focused Treatment With Additional Motor Control Exercises on Pain and Disability in Patients With Subacromial Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Rehabilitation, Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scapula-focused exercises
Arm Type
Active Comparator
Arm Description
Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions
Arm Title
Motor control exercises
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Scapula-focused exercises
Intervention Type
Other
Intervention Name(s)
Motor control exercises
Primary Outcome Measure Information:
Title
Change in Functionality Evaluated With Specific Questionnaire
Description
The Brazilian version of Shoulder Pain and Disability Index ranging 0 to 100 points. Lower scores indicate better functionality
Time Frame
baseline, four and eight weeks and sixteen weeks after randomization
Secondary Outcome Measure Information:
Title
Change in Intensity of Pain Evaluated by a Scale
Description
Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain
Time Frame
baseline, four and eight weeks and sixteen weeks after randomization
Title
Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF)
Description
Strength of serratus anterior, trapezius muscles, abduction, adduction, internal and external rotation movements the arm with hand held Dynamometer.
Time Frame
baseline, four and eight weeks and sixteen weeks after randomization
Title
Perceived Change Evaluated by Numerical Scale
Description
Global Perceived Effect Scale ranging -5 to +5 points. Positive values indicate improvement and negative values indicate worsening of symptoms
Time Frame
four, eight weeks and sixteen weeks of randomization
Title
Change in Kinesiophobia Evaluated With Specific Questionnaire
Description
Tampa Scale of Kinesiophobia ranging 17 to 68 points. High scores indicate high degree kinesiophobia
Time Frame
baseline, four and eight weeks and sixteen weeks after randomization
Title
Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees
Description
abduction, adduction, internal and external rotation of the shoulder
Time Frame
baseline, four and eight weeks and sixteen weeks after randomization
Title
Satisfaction With Treatment Evaluated With Specific Questionnaire
Description
Medrisk Questionnaire ranging 13 to 80 points. High scores indicate satisfaction with treatment
Time Frame
four, eight weeks and sixteen weeks after randomization
Title
Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees
Description
upward rotation and tilt of the scapula
Time Frame
baseline, four and eight weeks and sixteen weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisele H Hotta
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo, Ribeirão Preto Medical School
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication of data in the form of article:12/2018
Citations:
PubMed Identifier
14573714
Citation
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Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome
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