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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scapula-focused exercises | Active Comparator | Side lying external rotation, prone horizontal abduction , Scapular punch, Knee Push, Full can, D1 Diagonal, three times a week, 8 weeks, 3x10 repetitions |
|
| Motor control exercises | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scapula-focused exercises | Other |
| ||
| Motor control exercises |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisele H Hotta | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo, Ribeirão Preto Medical School | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14573714 | Background | 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. | |
| 18438933 | Background | 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. |
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Publication of data in the form of article:12/2018
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Scapula-focused exercises |
| FG001 | 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 Scapula-focused exercises Motor control exercises |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Scapula-focused exercises |
| BG001 | Motor Control Exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | baseline, four and eight weeks and sixteen weeks after randomization |
|
16 weeks after baseline data collection
All-Cause Mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Scapula-focused exercises |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac arrest | Cardiac disorders | Systematic Assessment |
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The limitation of the present study was that the therapist was not blinded concerning treatment assignment and this study did not assess and exclude individuals with central sensitization and high catastrophizing levels
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anamaria Siriani de Oliveira | University of São Paulo | +551633154415 | siriani@fmrp.usp.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2019 | Aug 15, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2019 | Aug 15, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| Other |
|
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 | 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 | 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 | 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 | 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 | upward rotation and tilt of the scapula | baseline, four and eight weeks and sixteen weeks after randomization |
| 22581193 | Background | 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. |
| 25920340 | Background | 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. |
| 19887215 | Background | 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. |
| 11690728 | Background | 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. |
| 18427325 | Background | 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. |
| 23160271 | Background | 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. |
| 20557263 | Background | 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. |
| 22785606 | Background | 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. |
| 19194023 | Background | 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. |
| 18469224 | Background | 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. |
| 25664288 | Result | 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. |
| 23053685 | Result | 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. |
| 21658987 | Result | 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. |
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 Scapula-focused exercises Motor control exercises |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (m) | Mean | Standard Deviation | meters |
|
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Right hand Dominance | Count of Participants | Participants |
|
| Painful shoulder on the dominant side | Count of Participants | Participants |
|
| Duration of symptoms (mo) | Mean | Standard Deviation | months |
|
| Medication for pain | Count of Participants | Participants |
|
| Body mass (Kg) | Mean | Standard Deviation | Kilograms |
|
|
|
| Secondary | Change in Intensity of Pain Evaluated by a Scale | Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain | Posted | Mean | 95% Confidence Interval | units on a scale | 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. | Posted | Mean | 95% Confidence Interval | Kilogram-force | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 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 | Posted | Mean | 95% Confidence Interval | degrees | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 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 | Posted | Mean | 95% Confidence Interval | degrees | baseline, four and eight weeks and sixteen weeks after randomization |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 Scapula-focused exercises Motor control exercises | 1 | 30 | 1 | 30 | 0 | 30 |
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| 8 weeks |
|
| 16 weeks |
|
| Shoulder abduction 8 weeks |
|
| Shoulder abduction 16 weeks |
|
| Shoulder adduction baseline |
|
| Shoulder adduction 4 weeks |
|
| Shoulder adduction 8 weeks |
|
| Shoulder adduction 16 weeks |
|
| Shoulder external rotation baseline |
|
| Shoulder external rotation 4 weeks |
|
| Shoulder external rotation 8 weeks |
|
| Shoulder external rotation 16 weeks |
|
| Shoulder Internal rotation baseline |
|
| Shoulder Internal rotation 4 weeks |
|
| Shoulder Internal rotation 8 weeks |
|
| Shoulder Internal rotation 16 weeks |
|
| Serratus Anterior Baseline |
|
| Serratus Anterior 4 weeks |
|
| Serratus Anterior 8 weeks |
|
| Serratus Anterior 16 weeks |
|
| Upper Trapezius Baseline |
|
| Upper Trapezius 4 weeks |
|
| Upper Trapezius 8 weeks |
|
| Upper Trapezius 16 weeks |
|
| Middle Trapezius Baseline |
|
| Middle Trapezius 4 weeks |
|
| Middle Trapezius 8 weeks |
|
| Middle Trapezius 16 weeks |
|
| Lower Trapezius baseline |
|
| Lower Trapezius 4 weeks |
|
| Lower Trapezius 8 weeks |
|
| Lower Trapezius 16 weeks |
|
| 16 weeks |
|
| Kinesiophobia 8 weeks |
|
| Kinesiophobia 16 weeks |
|
| Shoulder Flexion 8 weeks |
|
| Shoulder Flexion 16 weeks |
|
| Shoulder Abduction Baseline |
|
| Shoulder Abduction 4 weeks |
|
| Shoulder Abduction 8 weeks |
|
| Shoulder Abduction 16 weeks |
|
| Shoulder External Rotation Baseline |
|
| Shoulder External Rotation 4 weeks |
|
| Shoulder External Rotation 8 weeks |
|
| Shoulder External Rotation 16 weeks |
|
| Shoulder Internal Rotation Baseline |
|
| Shoulder Internal Rotation 4 weeks |
|
| Shoulder Internal Rotation 8 weeks |
|
| Shoulder Internal Rotation 16 weeks |
|
| Medrisk 16 weeks |
|
| Upward Rotation 0º 8 weeks |
|
| Upward Rotation 0º 16 weeks |
|
| Upward Rotation 90º baseline |
|
| Upward Rotation 90º 4 weeks |
|
| Upward Rotation 90º 8 weeks |
|
| Upward Rotation 90º 16 weeks |
|
| Upward Rotation 180º baseline |
|
| Upward Rotation 180º 4 weeks |
|
| Upward Rotation 180º 8 weeks |
|
| Upward Rotation 180º 16 weeks |
|
| Anterior Tilt 0º baseline |
|
| Anterior Tilt 0º 4 weeks |
|
| Anterior Tilt 0º 8 weeks |
|
| Anterior Tilt 0º 16 weeks |
|
| Anterior Tilt 90º baseline |
|
| Anterior Tilt 90º 4 weeks |
|
| Anterior Tilt 90º 8 weeks |
|
| Anterior Tilt 90º 16 weeks |
|
| Anterior Tilt 180º baseline |
|
| Anterior Tilt 180º 4 weeks |
|
| Anterior Tilt 180º 8 weeks |
|
| Anterior Tilt 180º 16 weeks |
|