Shoulder Impingement Syndrome Clinical Trial
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
NCT number | NCT02695524 |
Other study ID # | U1111-1179-1921 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | August 2017 |
Verified date | August 2019 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo, Ribeirão Preto Medical School | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Abdulla SY, Southerst D, Côté 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. — View Citation
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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. — View 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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | baseline, four and eight weeks and sixteen weeks after randomization | |
Secondary | Change in Intensity of Pain Evaluated by a Scale | Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain | baseline, four and eight weeks and sixteen weeks after randomization | |
Secondary | 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. | baseline, four and eight weeks and sixteen weeks after randomization | |
Secondary | 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 | four, eight weeks and sixteen weeks of randomization | |
Secondary | Change in Kinesiophobia Evaluated With Specific Questionnaire | 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 | |
Secondary | Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees | abduction, adduction, internal and external rotation of the shoulder | baseline, four and eight weeks and sixteen weeks after randomization | |
Secondary | Satisfaction With Treatment Evaluated With Specific Questionnaire | Medrisk Questionnaire ranging 13 to 80 points. High scores indicate satisfaction with treatment | four, eight weeks and sixteen weeks after randomization | |
Secondary | Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees | upward rotation and tilt of the scapula | baseline, four and eight weeks and sixteen weeks after randomization |
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