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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
| Oulu University Hospital | OTHER |
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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.
Subgroup analysis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acromioplasty | Active Comparator | Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment |
|
| Physiotherapy | Active Comparator | Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acromioplasty | Procedure | Arthroscopic or open acromioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in pain (VAS) and objective shoulder function (Constant score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Paloneva, MD, PhD | Central Finland Health Care District, University of Eastern Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki | Helsinki | Finland | ||||
| Central Finland Health District |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10226960 | Background | 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. | |
| 15834056 |
| Label | URL |
|---|---|
| Clinical Musculoskeletal Diseases Research Group internet pages | View source |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physiotherapy | Procedure | Physiotherapy according to a standardized protocol |
|
|
VAS (0 to 100 mm), Constant score (0 to 100 points)
| 6 months after intervention |
| 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 |
| 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 |
| Jyväskylä |
| FIN-40620 |
| Finland |
| Oulu University Hospital | Oulu | Finland |
| Background |
| 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. |
| 23836479 | Background | 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. |
| 19794168 | Background | 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. |
| 16766370 | Background | 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. |
| 27348693 | Background | 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. |
| 28566400 | Background | 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. |
| 33272959 | Derived | 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. |