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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02153827
Other study ID # 12111308exp
Secondary ID
Status Recruiting
Phase N/A
First received March 31, 2014
Last updated April 13, 2015
Start date March 2014
Est. completion date September 2016

Study information

Verified date April 2015
Source Nova Southeastern University
Contact Eric J Chaconas, DPT
Phone 9048260084
Email echaconas@usa.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of eccentric exercise to the shoulder muscles for people with shoulder pain. Identifying specific exercise protocols for individuals with shoulder pain will provide evidence to help clinicians select the best interventions.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date September 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Presence of non-acute shoulder pain (greater than 3 months duration)

- 3 out of the 6 following tests positive, Neer impingement, Hawkins-Kennedy impingement, empty can test, resisted external rotation test, palpable tenderness at the insertion of the supraspinatus or infraspinatus, and painful arc from 60° to 120° during active abduction.

- Age over 18 years old

- Sufficient ability to read English as required for completing questionnaires

Exclusion Criteria:

- Red flags noted in the patient's Medical Screening Questionnaire (MSQ) (ie. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use)

- Full thickness supraspinatus or infraspinatus tendon tear as determined by a positive drop arm test, lag sign or rent test.

- Shoulder adhesive capsulitis as evidenced by a limitation in passive motion for all shoulder planes of movement.

- Having an upper extremity amputation.

- Individuals having a history of surgery to the cervical spine or involved upper extremity for a musculoskeletal, neurological or dermatological condition for which they are at the time of data collection receiving post-operative care.

- Pending legal action regarding their shoulder pain

- Inability to comply with treatment and follow up schedule

- Insufficient English language skills to complete all questionnaires

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Other:
Eccentric Shoulder External Rotator Training

General Shoulder exercise
general exercise consisting of active shoulder movements

Locations

Country Name City State
United States University of St. Augustine St. Augustine Florida

Sponsors (2)

Lead Sponsor Collaborator
Nova Southeastern University University of St. Augustine

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bernhardsson S, Klintberg IH, Wendt GK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil. 2011 Jan;25(1):69-78. doi: 10.1177/0269215510376005. Ep — View Citation

Camargo PR, Avila MA, Alburquerque-Sendín F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. — View Citation

Holmgren T, Björnsson Hallgren H, Öberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787. — View Citation

Jonsson P, Wahlström P, Ohberg L, Alfredson H. Eccentric training in chronic painful impingement syndrome of the shoulder: results of a pilot study. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):76-81. Epub 2005 May 5. — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in external to internal and abduction strength ratios week 1,3, 6 and 6 months No
Primary Change in bodyweight adjusted mean isometric strength measured in force pounds week 1,3,6, 6 months No
Primary Change in Western Ontario Rotator Cuff Index shoulder functional self report measure week 1,3,6 and 6 months No
Secondary Global rating of change week 3,6 and 6 months No
Secondary Numeric Pain rating scale week 1,3,6 and 6 months No
Secondary shoulder active range of motion week 1,3,6 and 6 months No
Secondary Upper quarter Y balance test week 1,3,6 and 6 months No
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