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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01054326
Other study ID # DNR 02-37
Secondary ID
Status Completed
Phase N/A
First received January 21, 2010
Last updated January 21, 2010
Start date January 2003
Est. completion date January 2007

Study information

Verified date January 2006
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study was to evaluate and compare two different post-surgical rehabilitation strategies, Rehabilitation supervised by a physical therapist including exercises with progressive early activation of the rotator cuff versus basic home exercises regarding shoulder function, pain, health related quality of life and return to work after arthroscopic subacromial decompression.


Description:

Patients scheduled for surgery (arthroscopic subacromial decompression)and in the age 25-65 were offered to participate in the study. After surgery they were randomized to either Supervised Physical therapy with early activation of the rotator cuff (PT-group) or to home exercises (H-group). Patients in the PT group met the physical therapist twice a week for exercises and in between these visits they did their exercises at home daily. The H-group did home exercises daily. Shoulder function and pain(primary outcomes)and health related quality of life, returning to work(secondary outcomes)were assessed before surgery, one week after(baseline), 1,2,3 and 6 months after surgery by an independent physical therapist.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2007
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Subacromial impingement verified with Neer impingement test

- At least 6 month duration of pain

- Treated in primary care without satisfactory results for at least three months.

- Typical history and pain location. Scheduled for surgery (subacromial decompression)

- Three of these four tests must be positive:

- Neer impingement test

- Hawkins-Kennedy impingement sign Jobe supraspinatus test

- Painful arc 60-120 degree

Exclusion Criteria:

- Radiological findings of malignancy osteoarthritis, fractures

- Polyarthritis or fibromyalgia

- Pathological hyper laxity

- Lack of communication skills that prevent the use of outcome measurements

- Cervical spine pathology

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Exercises


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Linkoeping University Kalmar County Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder function and pain before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery No
Secondary Health related quality of life and returning to work before surhery and 1 w(baseline)1,2,3 and 6 months after surgery
See also
  Status Clinical Trial Phase
Terminated NCT02867904 - Intra-Operative Corticosteroid Injection During Arthroscopic Shoulder Surgery Phase 4