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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Rehabilitation, Shoulder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 19, 2016
Last Updated
August 15, 2019
Sponsor
University of Sao Paulo
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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
Ludewig PM, Borstad JD. Effects of a home exercise programme on shoulder pain and functional status in construction workers. Occup Environ Med. 2003 Nov;60(11):841-9. doi: 10.1136/oem.60.11.841.
Results Reference
background
PubMed Identifier
18438933
Citation
Lombardi I Jr, Magri AG, Fleury AM, Da Silva AC, Natour J. Progressive resistance training in patients with shoulder impingement syndrome: a randomized controlled trial. Arthritis Rheum. 2008 May 15;59(5):615-22. doi: 10.1002/art.23576.
Results Reference
background
PubMed Identifier
22581193
Citation
Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
Results Reference
background
PubMed Identifier
25920340
Citation
Abdulla SY, Southerst D, Cote P, Shearer HM, Sutton D, Randhawa K, Varatharajan S, Wong JJ, Yu H, Marchand AA, Chrobak K, Woitzik E, Shergill Y, Ferguson B, Stupar M, Nordin M, Jacobs C, Mior S, Carroll LJ, van der Velde G, Taylor-Vaisey A. Is exercise effective for the management of subacromial impingement syndrome and other soft tissue injuries of the shoulder? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):646-56. doi: 10.1016/j.math.2015.03.013. Epub 2015 Apr 1.
Results Reference
background
PubMed Identifier
19887215
Citation
Michener LA, Walsworth MK, Doukas WC, Murphy KP. Reliability and diagnostic accuracy of 5 physical examination tests and combination of tests for subacromial impingement. Arch Phys Med Rehabil. 2009 Nov;90(11):1898-903. doi: 10.1016/j.apmr.2009.05.015.
Results Reference
background
PubMed Identifier
11690728
Citation
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Results Reference
background
PubMed Identifier
18427325
Citation
de Souza FS, Marinho Cda S, Siqueira FB, Maher CG, Costa LO. Psychometric testing confirms that the Brazilian-Portuguese adaptations, the original versions of the Fear-Avoidance Beliefs Questionnaire, and the Tampa Scale of Kinesiophobia have similar measurement properties. Spine (Phila Pa 1976). 2008 Apr 20;33(9):1028-33. doi: 10.1097/BRS.0b013e31816c8329.
Results Reference
background
PubMed Identifier
23160271
Citation
De Mey K, Danneels LA, Cagnie B, Huyghe L, Seyns E, Cools AM. Conscious correction of scapular orientation in overhead athletes performing selected shoulder rehabilitation exercises: the effect on trapezius muscle activation measured by surface electromyography. J Orthop Sports Phys Ther. 2013 Jan;43(1):3-10. doi: 10.2519/jospt.2013.4283. Epub 2012 Nov 16.
Results Reference
background
PubMed Identifier
20557263
Citation
Mullaney MJ, McHugh MP, Johnson CP, Tyler TF. Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiother Theory Pract. 2010 Jul;26(5):327-33. doi: 10.3109/09593980903094230.
Results Reference
background
PubMed Identifier
22785606
Citation
De Mey K, Danneels L, Cagnie B, Cools AM. Scapular muscle rehabilitation exercises in overhead athletes with impingement symptoms: effect of a 6-week training program on muscle recruitment and functional outcome. Am J Sports Med. 2012 Aug;40(8):1906-15. doi: 10.1177/0363546512453297. Epub 2012 Jul 11.
Results Reference
background
PubMed Identifier
19194023
Citation
Reinold MM, Escamilla RF, Wilk KE. Current concepts in the scientific and clinical rationale behind exercises for glenohumeral and scapulothoracic musculature. J Orthop Sports Phys Ther. 2009 Feb;39(2):105-17. doi: 10.2519/jospt.2009.2835.
Results Reference
background
PubMed Identifier
18469224
Citation
Kibler WB, Sciascia AD, Uhl TL, Tambay N, Cunningham T. Electromyographic analysis of specific exercises for scapular control in early phases of shoulder rehabilitation. Am J Sports Med. 2008 Sep;36(9):1789-98. doi: 10.1177/0363546508316281. Epub 2008 May 9.
Results Reference
background
PubMed Identifier
25664288
Citation
Moezy A, Sepehrifar S, Solaymani Dodaran M. The effects of scapular stabilization based exercise therapy on pain, posture, flexibility and shoulder mobility in patients with shoulder impingement syndrome: a controlled randomized clinical trial. Med J Islam Repub Iran. 2014 Aug 27;28:87. eCollection 2014.
Results Reference
result
PubMed Identifier
23053685
Citation
Struyf F, Nijs J, Mollekens S, Jeurissen I, Truijen S, Mottram S, Meeusen R. Scapular-focused treatment in patients with shoulder impingement syndrome: a randomized clinical trial. Clin Rheumatol. 2013 Jan;32(1):73-85. doi: 10.1007/s10067-012-2093-2. Epub 2012 Oct 2.
Results Reference
result
PubMed Identifier
21658987
Citation
Armijo-Olivo S, Warren S, Fuentes J, Magee DJ. Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example. Man Ther. 2011 Dec;16(6):563-72. doi: 10.1016/j.math.2011.05.006. Epub 2011 Jun 12.
Results Reference
result

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Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome

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