Clinical trial NCT02695524: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Rehabilitation
Shoulder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Functionality Evaluated With Specific Questionnaire
timeFrame: baseline, four and eight weeks and sixteen weeks after randomization
Secondary outcomes:
measure: Change in Intensity of Pain Evaluated by a Scale
timeFrame: baseline, four and eight weeks and sixteen weeks after randomization
measure: Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF)
timeFrame: baseline, four and eight weeks and sixteen weeks after randomization
measure: Perceived Change Evaluated by Numerical Scale
timeFrame: four, eight weeks and sixteen weeks of randomization
measure: Change in Kinesiophobia Evaluated With Specific Questionnaire
timeFrame: baseline, four and eight weeks and sixteen weeks after randomization
measure: Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees
timeFrame: baseline, four and eight weeks and sixteen weeks after randomization
measure: Satisfaction With Treatment Evaluated With Specific Questionnaire
timeFrame: four, eight weeks and sixteen weeks after randomization
measure: Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees
timeFrame: baseline, four and eight weeks and sixteen weeks after randomization
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, Ribeirão Preto Medical School
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Gisele H Hotta
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.