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Subacromial Impingement SyndromeNCT00637013

Operative Versus Non-operative Management of Subacromial Impingement

A study testing Acromioplasty and Physiotherapy in people with Subacromial Impingement Syndrome, run by Central Finland Hospital District at 3 sites in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Subacromial Impingement Syndrome
What is being tested?
Acromioplasty and Physiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesFinland
Study dates
Jun 2008to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • a progressive malign disease
  • adhesive capsulitis
  • high-energy trauma before symptoms
  • cervical syndrome
  • shoulder instability

Trial locations and contacts

3 sites in 1 country.

Finland3 sites

  • University of Helsinki

    Helsinki

  • Central Finland Health District

    Jyväskylä, FIN-40620

  • Oulu University Hospital

    Oulu

Other trials in Finland

About this study

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

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.

Read the 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
Being tested
Acromioplasty, Physiotherapy
Keywords
Subacromial impingement, Shoulder, RCT, Effectiveness, Cost-effectiveness
Medical subject headings
Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcromioplastyProcedure or surgery

    Also called Subacromial decompression

    Arthroscopic or open acromioplasty

  • PhysiotherapyProcedure or surgery

    Also called Physical therapy, Non-operative treatment

    Physiotherapy according to a standardized protocol

Study groups in NCT00637013
Study groupRoleWhat they receive
AcromioplastyActive comparatorAcromioplasty + physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Receives: Procedure: Acromioplasty
PhysiotherapyActive comparatorPhysiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Receives: Procedure: Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    VAS (0 to 100 mm), Constant score (0 to 100 points)

    Measured: 24 months after intervention

Secondary outcomes (4)

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

    VAS (0 to 100 mm), Constant score (0 to 100 points)

    Measured: 3 months after intervention

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

    VAS (0 to 100 mm), Constant score (0 to 100 points)

    Measured: 6 months after intervention

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

    VAS (0 to 100 mm), Constant score (0 to 100 points)

    Measured: 12 months after intervention

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

    VAS (0 to 100 mm), Constant score (0 to 100 points)

    Measured: 5 years after uintervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2017
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00637013
Sponsor's protocol ID
B07103
Status last verified
Feb 2024
First submitted
10 Mar 2008
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 10226960

  • 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.

    PubMed 15834056

  • 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.

    PubMed 23836479

  • 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.

    PubMed 19794168

  • 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.

    PubMed 16766370

  • 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.

    PubMed 27348693

  • 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.

    PubMed 28566400

  • 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.

    PubMed 33272959

Questions about this trial

What is this clinical trial studying?

A study testing Acromioplasty and Physiotherapy in people with Subacromial Impingement Syndrome, run by Central Finland Hospital District at 3 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain (VAS) and objective shoulder function (Constant score) (time frame: 24 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00637013, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.

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