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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Operative or Conservative Treatment for Subacromial Impingement Syndrome?

NCT00428870

Subacromial Impingement Syndrome

UNKNOWN NA

Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement

NCT01753271

Subacromial Impingement Syndrome

COMPLETED NA

Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome

NCT00632996

Shoulder Impingement Syndrome

COMPLETED PHASE2

Comparison of Exercise Interventions in Adults With Subacromial Impingement Syndrome

NCT01508715

Shoulder Impingement Syndrome

COMPLETED NA

Exercise Training Sequence for Subacromial Impingement Syndrome

NCT02478567

Subacromial Impingement Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subacromial Impingement Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PT progressive exercises

A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed

Group Type EXPERIMENTAL

Exercise program

Intervention Type PROCEDURE

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 neck and shoulder

General movements for the neck and shoulder,

Group Type ACTIVE_COMPARATOR

Exercise program

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eccentric Rotator cuff Exercises Scapular stabilization Exercises posture

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No