Operative Versus Non-operative Management of Subacromial Impingement

NCT00637013 | Active Not Recruiting DMC

• 1 other identifier: B07103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial impingement; Shoulder; RCT; Effectiveness; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in pain (VAS) and objective shoulder function (Constant score)

  3 months after intervention

• Change in pain (VAS) and objective shoulder function (Constant score)

  6 months after intervention

• Change in pain (VAS) and objective shoulder function (Constant score)

  12 months after intervention

• Change in pain (VAS) and objective shoulder function (Constant score)

  5 years after uintervention

Study Arms (2)

Acromioplasty

ACTIVE COMPARATOR

Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment

Procedure: Acromioplasty

Physiotherapy

ACTIVE COMPARATOR

Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment

Procedure: Physiotherapy

Interventions

Acromioplasty PROCEDURE

Arthroscopic or open acromioplasty

Also known as: Subacromial decompression

Acromioplasty

Physiotherapy PROCEDURE

Physiotherapy according to a standardized protocol

Also known as: Physical therapy, Non-operative treatment

Physiotherapy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Finland Hospital District: lead
• Academy of Finland: collaborator
• Oulu University Hospital: collaborator

Study Sites (3)

University of Helsinki

Helsinki, Finland

Location

Central Finland Health District

Jyväskylä, FIN-40620, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Related Publications (8)

• 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.

  PMID: 10226960 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.

  PMID: 15834056 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.

  PMID: 23836479 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.

  PMID: 19794168 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.

  PMID: 16766370 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.

  PMID: 27348693 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.

  PMID: 28566400 BACKGROUND

• 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.

  PMID: 33272959 DERIVED

Related Links

• Clinical Musculoskeletal Diseases Research Group internet pages

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Juha Paloneva, MD, PhD

  Central Finland Health Care District, University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2017
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

FI (3)