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

L

Linköping University (LiU)

Status

Completed

Conditions

Subacromial Impingement Syndrome

Treatments

Procedure: Movement exercises
Procedure: Exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT01037673
88201401

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

102 participants in 2 patient groups

PT progressive exercises
Experimental group
Description:
A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed
Treatment:
Procedure: Exercise program
Movement exercises neck and shoulder
Active Comparator group
Description:
General movements for the neck and shoulder,
Treatment:
Procedure: Exercise program
Procedure: Movement exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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