Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises

Subacromial Impingement Syndrome Clinical Trial

Official title:

Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037673
• Other study ID #: 88201401
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: June 16, 2011
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Objective:

A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement.

Hypothesis:

H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered.

H0 No difference between the two exercises (experimental and active control) and the patients still need surgery

Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months.

Method:

Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months.

Importance of the study results:

Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Subacromial impingement verified with Neer impingement injection test

• At least 6 months duration

• Treated in primary care without satisfactory result for at least 6 months

Three of these five must be positive:

• Neer impingement sign

• Hawkins-Kennedy impingement sign

• Jobe supraspinatus test

• Patte maneuver

• Typical history and pain location (C5 dermatome)

Exclusion Criteria:

• Radiological finding of malignancy, osteoarthritis, fractures

• Polyarthritis or fibromyalgia

• Pathological hyper-laxity or dislocation of the any of the shoulder joints

• Cervical spine pathology

• Lack of communication skills that prevent the use of outcome measures

Study Design

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

Procedure:
• Exercise program
A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
• Movement exercises
A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.

Locations

Country	Name	City	State
Sweden	University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant-Murley shoulder assessment	Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.; The score is summarized to a maximum of 100 for best available shoulder function.	Baseline and change after three months of exercises, 3 month follow-up	No
Primary	Constant_Murley shoulder assessment	Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.; The score is summarized to a maximum of 100 for best available shoulder function.	Change from baseline to the 12-month follow-up	No
Secondary	Health Related Quality of Life by EuroQol 5 dimensions	Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.	Baseline and change aftert three months of exercises	No
Secondary	Health Related Quality of Life by EuroQol 5 dimensions	Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.	Change from baseline to the 12-month follow-up	No