NCT02695524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 19, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

February 19, 2016

Results QC Date

December 17, 2018

Last Update Submit

August 15, 2019

Conditions

Keywords

RehabilitationShoulder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in Intensity of Pain Evaluated by a Scale

    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)

    baseline, four and eight weeks and sixteen weeks after randomization

  • Perceived Change Evaluated by Numerical Scale

    four, eight weeks and sixteen weeks of randomization

  • Change in Kinesiophobia Evaluated With Specific Questionnaire

    baseline, four and eight weeks and sixteen weeks after randomization

  • Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees

    baseline, four and eight weeks and sixteen weeks after randomization

  • +2 more secondary outcomes

Study Arms (2)

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

Other: Scapula-focused exercises

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

Other: Scapula-focused exercisesOther: Motor control exercises

Interventions

Motor control exercisesScapula-focused exercises
Motor control exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo, Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (15)

  • 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.

    PMID: 14573714BACKGROUND
  • 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.

    PMID: 18438933BACKGROUND
  • 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.

    PMID: 22581193BACKGROUND
  • 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.

    PMID: 25920340BACKGROUND
  • 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.

    PMID: 19887215BACKGROUND
  • 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.

    PMID: 11690728BACKGROUND
  • 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.

    PMID: 18427325BACKGROUND
  • 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.

    PMID: 23160271BACKGROUND
  • 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.

    PMID: 20557263BACKGROUND
  • 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.

    PMID: 22785606BACKGROUND
  • 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.

    PMID: 19194023BACKGROUND
  • 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.

    PMID: 18469224BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Limitations and Caveats

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

Results Point of Contact

Title
Anamaria Siriani de Oliveira
Organization
University of São Paulo

Study Officials

  • Gisele H Hotta

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Biomechanics, Medicine and Rehabilitation of Locomotive Apparatus

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 1, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

August 19, 2019

Results First Posted

August 19, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Publication of data in the form of article:12/2018

Locations