Clinical trial NCT00637013: Operative Versus Non-operative Management of Subacromial Impingement
Official title: The Effectiveness and Cost-effectiveness of Operative Versus Non-operative Management of Subacromial Impingement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Subacromial Impingement Syndrome
Keywords: Subacromial impingement
Shoulder
RCT
Effectiveness
Cost-effectiveness
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: Academy of Finland
name: Oulu University Hospital
First posted: 2008-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 24 months after intervention
Secondary outcomes:
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 3 months after intervention
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 6 months after intervention
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 12 months after intervention
measure: Change in pain (VAS) and objective shoulder function (Constant score)
timeFrame: 5 years after uintervention
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
city: Jyväskylä
country: Finland
facility: Central Finland Health District
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Central Finland Health Care District, University of Eastern Finland
name: Juha Paloneva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
citation: Cederqvist S, Flinkkila T, Sormaala M, Ylinen J, Kautiainen H, Irmola T, Lehtokangas H, Liukkonen J, Pamilo K, Ridanpaa T, Sirnio K, Leppilahti J, Kiviranta I, Paloneva J. Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation. Ann Rheum Dis. 2021 Jun;80(6):796-802. doi: 10.1136/annrheumdis-2020-219099. Epub 2020 Dec 3.