Operative Versus Non-operative Management of Subacromial Impingement

Subacromial Impingement Syndrome Clinical Trial

Official title:

The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00637013
• Other study ID #: B07103
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2008
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: Central Finland Hospital District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims at determining the effectiveness and cost-effectiveness of surgical management of subacromial impingement (including partial tears) compared to conservative treatment. The research setting is prospective, randomised, and controlled.

The aim of the study is to search out evidence based data of indications for subacromial decompression. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when subacromial impingement is suspected.

The investigators hypothesise that there are subgroups of patients suffering from subacromial impingement that benefit from surgery whereas other subgroups are best treated conservatively.

Description:

Subgroup analysis:

• age

• sex

• duration of symptoms

• presence of trauma before symptoms

• presence of partial tear

• degenerative findings

• other findings in MRI or arthroscopy

• type of operation

• co-morbidities

• occupation

• pain (VAS)

• objective shoulder function

• activities of daily living

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2027
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• age over 35 years old

• duration of symptoms at least three months despite non-operative treatment

• accepts both treatment options (operative and physical therapy)

• must have pain in abduction of the shoulder

• must have painful arc

• must have pain in two of the three isometric tests (0 and 30 degrees of abduction, or external rotation)

• a positive result in the impingement test (a subacromial injection of lidocaine reduces pain)

Exclusion Criteria:

• previous shoulder operations

• too high risk for operation

• any disease or social problem reducing the ability to co-operate

• rheumatoid arthritis

• severe arthrosis of the glenohumeral or acromioclavicular joint

• a full-thickness rotator cuff tear in MRI arthrography

• a progressive malign disease

• adhesive capsulitis

• high-energy trauma before symptoms

• cervical syndrome

• shoulder instability

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

Procedure:
• Acromioplasty
Arthroscopic or open acromioplasty
• Physiotherapy
Physiotherapy according to a standardized protocol

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki
Finland	Central Finland Health District	Jyväskylä
Finland	Oulu University Hospital	Oulu

Sponsors (3)

Lead Sponsor	Collaborator
Central Finland Hospital District	Academy of Finland, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Brox JI, Gjengedal E, Uppheim G, Bohmer AS, Brevik JI, Ljunggren AE, Staff PH. Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up. J Shoulder Elbow Surg. 1999 Mar-Apr;8(2):102-11. doi: 10.1016/s1058-2746(99)90001-0. — View Citation

Haahr JP, Andersen JH. Exercises may be as efficient as subacromial decompression in patients with subacromial stage II impingement: 4-8-years' follow-up in a prospective, randomized study. Scand J Rheumatol. 2006 May-Jun;35(3):224-8. doi: 10.1080/03009740600556167. — View Citation

Haahr JP, Ostergaard S, Dalsgaard J, Norup K, Frost P, Lausen S, Holm EA, Andersen JH. Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis. 2005 May;64(5):760-4. doi: 10.1136/ard.2004.021188. — View Citation

Ketola S, Lehtinen J, Arnala I, Nissinen M, Westenius H, Sintonen H, Aronen P, Konttinen YT, Malmivaara A, Rousi T. Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised controlled trial. J Bone Joint Surg Br. 2009 Oct;91(10):1326-34. doi: 10.1302/0301-620X.91B10.22094. — View Citation

Ketola S, Lehtinen J, Elo P, Kortelainen S, Huhtala H, Arnala I. No difference in long-term development of rotator cuff rupture and muscle volumes in impingement patients with or without decompression. Acta Orthop. 2016 Aug;87(4):351-5. doi: 10.1080/17453674.2016.1177780. Epub 2016 Jun 27. — View Citation

Ketola S, Lehtinen J, Rousi T, Nissinen M, Huhtala H, Konttinen YT, Arnala I. No evidence of long-term benefits of arthroscopicacromioplasty in the treatment of shoulder impingement syndrome: Five-year results of a randomised controlled trial. Bone Joint Res. 2013 Jul 1;2(7):132-9. doi: 10.1302/2046-3758.27.2000163. Print 2013. — View Citation

Ketola S, Lehtinen JT, Arnala I. Arthroscopic decompression not recommended in the treatment of rotator cuff tendinopathy: a final review of a randomised controlled trial at a minimum follow-up of ten years. Bone Joint J. 2017 Jun;99-B(6):799-805. doi: 10.1302/0301-620X.99B6.BJJ-2016-0569.R1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain (VAS) and objective shoulder function (Constant score)	VAS (0 to 100 mm), Constant score (0 to 100 points)	24 months after intervention
Secondary	Change in pain (VAS) and objective shoulder function (Constant score)	VAS (0 to 100 mm), Constant score (0 to 100 points)	3 months after intervention
Secondary	Change in pain (VAS) and objective shoulder function (Constant score)	VAS (0 to 100 mm), Constant score (0 to 100 points)	6 months after intervention
Secondary	Change in pain (VAS) and objective shoulder function (Constant score)	VAS (0 to 100 mm), Constant score (0 to 100 points)	12 months after intervention
Secondary	Change in pain (VAS) and objective shoulder function (Constant score)	VAS (0 to 100 mm), Constant score (0 to 100 points)	5 years after uintervention

External Links

•   Clinical Musculoskeletal Diseases Research Group internet pages