NCT01054326

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2006

Enrollment Period

3 years

First QC Date

January 21, 2010

Last Update Submit

January 21, 2010

Conditions

Keywords

arthroscopic subacromial decompressionexercisephysical therapyrotator cuffshoulder impingement syndromeSubacromial impingement after arthroscopic subacromial decompression

Outcome Measures

Primary Outcomes (1)

  • Shoulder function and pain

    before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery

Secondary Outcomes (1)

  • Health related quality of life and returning to work

    before surhery and 1 w(baseline)1,2,3 and 6 months after surgery

Study Arms (2)

Supervised physical therapy focusing of rotatorcuff exercises

EXPERIMENTAL

Patients did specific exercises supervised by a physical therapists twice a week during two months. Focus was on early activation of rotator cuff and scapula stabilizers following different phases in a rehabilitation program Assessments before surgery,1 week after as well as 1,2,3 and 6 months after surgery.

Other: Exercises

Home exercises

ACTIVE COMPARATOR

Patients did home exercises following a programme during three months. Assessment considering shoulder function and pain was done before surgery, 1w after as well as 1,2,3 and 6 months after surgery,

Other: Exercises

Interventions

Home exercisesSupervised physical therapy focusing of rotatorcuff exercises

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityShoulder Impingement Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorJoint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

January 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2007

Last Updated

January 22, 2010

Record last verified: 2006-01