Clinical trial NCT01037673: Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises
Official title: Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2009-12-23
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Constant-Murley shoulder assessment
timeFrame: Baseline and change after three months of exercises, 3 month follow-up
measure: Constant_Murley shoulder assessment
timeFrame: Change from baseline to the 12-month follow-up
Secondary outcomes:
measure: Health Related Quality of Life by EuroQol 5 dimensions
timeFrame: Baseline and change aftert three months of exercises
measure: Health Related Quality of Life by EuroQol 5 dimensions
timeFrame: Change from baseline to the 12-month follow-up
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital
Study officials:
affiliation: Linkoeping University
name: Kajsa Johansson, PhD, RPT
role: STUDY_CHAIR
References:
citation: Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.
citation: Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.
citation: Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.