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

NCT01037673 | Completed

• 1 other identifier: 88201401
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Health Related Quality of Life by EuroQol 5 dimensions

  Baseline and change aftert three months of exercises

• Health Related Quality of Life by EuroQol 5 dimensions

  Change from baseline to the 12-month follow-up

Study Arms (2)

PT progressive exercises

EXPERIMENTAL

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

Procedure: Exercise program

Movement exercises neck and shoulder

ACTIVE COMPARATOR

General movements for the neck and shoulder,

Procedure: Exercise program; Procedure: Movement exercises

Interventions

Exercise program PROCEDURE

A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.

Also known as: Eccentric, Rotator cuff, Exercises, Scapular stabilization

Movement exercises neck and shoulder; PT progressive exercises

Movement exercises 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.

Also known as: Exercises, posture

Movement exercises neck and shoulder

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

University Hospital

Linköping, 581 85, Sweden

Location

Related Publications (3)

• 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.

  PMID: 25213604 DERIVED

• 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.

  PMID: 24970843 DERIVED

• 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.

  PMID: 22349588 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Resistance Training; Exercise; Exercise Movement Techniques; Posture

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kajsa Johansson, PhD, RPT

  Linkoeping University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 17, 2011

Record last verified: 2009-12

Locations

SE (1)