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

Not Applicable

Completed

• Conditions: Subacromial Impingement Syndrome
• Interventions: Procedure: Exercise program; Procedure: Movement exercises

• Registration Number: NCT01037673
• Lead Sponsor: Linkoeping University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Primary Completion: 2010-03
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PT progressive exercises	Exercise program	A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed
Movement exercises neck and shoulder	Exercise program	General movements for the neck and shoulder,
Movement exercises neck and shoulder	Movement exercises	General movements for the neck and shoulder,

Primary Outcome Measures

Name	Time	Method
Constant-Murley shoulder assessment	Baseline and change after three months of exercises, 3 month follow-up	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.
Constant_Murley shoulder assessment	Change from baseline to the 12-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life by EuroQol 5 dimensions	Change from baseline to the 12-month follow-up	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.

Trial Locations

Locations (1)

University Hospital; 🇸🇪 Linköping, Sweden