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Operative Versus Non-operative Management of Subacromial Impingement

Primary Purpose

Subacromial Impingement Syndrome

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Acromioplasty
Physiotherapy
Sponsored by
Central Finland Hospital District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Subacromial impingement, Shoulder, RCT, Effectiveness, Cost-effectiveness

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Helsinki
  • Central Finland Health District
  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Acromioplasty

Physiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)

Secondary Outcome Measures

Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)
Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)
Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)
Change in pain (VAS) and objective shoulder function (Constant score)
VAS (0 to 100 mm), Constant score (0 to 100 points)

Full Information

First Posted
March 10, 2008
Last Updated
February 7, 2023
Sponsor
Central Finland Hospital District
Collaborators
Academy of Finland, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00637013
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2008 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Finland Hospital District
Collaborators
Academy of Finland, Oulu University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Subacromial impingement, Shoulder, RCT, Effectiveness, Cost-effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acromioplasty
Arm Type
Active Comparator
Arm Description
Acromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Intervention Type
Procedure
Intervention Name(s)
Acromioplasty
Other Intervention Name(s)
Subacromial decompression
Intervention Description
Arthroscopic or open acromioplasty
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Physical therapy, Non-operative treatment
Intervention Description
Physiotherapy according to a standardized protocol
Primary Outcome Measure Information:
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
24 months after intervention
Secondary Outcome Measure Information:
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
3 months after intervention
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
6 months after intervention
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
12 months after intervention
Title
Change in pain (VAS) and objective shoulder function (Constant score)
Description
VAS (0 to 100 mm), Constant score (0 to 100 points)
Time Frame
5 years after uintervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
Organizational Affiliation
Central Finland Health Care District, University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Helsinki
City
Helsinki
Country
Finland
Facility Name
Central Finland Health District
City
Jyväskylä
ZIP/Postal Code
FIN-40620
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
10226960
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.
Results Reference
background
PubMed Identifier
15834056
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.
Results Reference
background
PubMed Identifier
23836479
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.
Results Reference
background
PubMed Identifier
19794168
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.
Results Reference
background
PubMed Identifier
16766370
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.
Results Reference
background
PubMed Identifier
27348693
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.
Results Reference
background
PubMed Identifier
28566400
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.
Results Reference
background
PubMed Identifier
33272959
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.
Results Reference
derived
Links:
URL
http://www.ksshp.fi/musculoskeletalresearch
Description
Clinical Musculoskeletal Diseases Research Group internet pages

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Operative Versus Non-operative Management of Subacromial Impingement

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