NCT00349648

Brief Summary

Study hypothesis: The impingement syndrome of the rotator cuff is a common cause of shoulder pain for which the most effective treatment is unknown. Steroid injections and anti-inflammatory analgetics are considered as effective methods. Physiotherapy and acromioplasty are commonly used treatments. Hypothesis: Arthroscopy and acromioplasty in addition to conservative treatment is equally effective as conservative treatment alone for shoulder impingement syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
Last Updated

July 7, 2006

Status Verified

July 1, 2006

First QC Date

July 6, 2006

Last Update Submit

July 6, 2006

Conditions

Shoulder Impingement Syndrome

Keywords

subacromialimpingementacromioplastyphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • shoulder pain in visual analogue scale (VAS) of 0-10 at two years after randomization

Secondary Outcomes (5)

  • pain at night

  • disability

  • ability to work

  • ranges of motion

  • cost-effectiveness

Interventions

acromioplastyPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • a positive clinical Neer's test
  • shoulder pain resistant to rest
  • shoulder pain resistant to anti-inflammatory drugs
  • shoulder pain resistant to subacromial steroid injections
  • shoulder pain resistant to ordinary physiotherapy with a minimum history of three months

You may not qualify if:

  • glenohumeral or acromioclavicular arthritis
  • glenohumeral instability
  • total rupture of the rotator cuff
  • cervical syndrome
  • adhesive capsulitis
  • neuropathy of the shoulder region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanta-Häme Central Hospital

Hämeenlinna, 13530, Finland

Location

Related Publications (6)

  • Brox JI, Staff PH, Ljunggren AE, Brevik JI. Arthroscopic surgery compared with supervised exercises in patients with rotator cuff disease (stage II impingement syndrome). BMJ. 1993 Oct 9;307(6909):899-903. doi: 10.1136/bmj.307.6909.899.

    PMID: 8241852BACKGROUND

  • Green S, Buchbinder R, Glazier R, Forbes A. Interventions for shoulder pain. Cochrane Database Syst Rev. 2000;(2):CD001156. doi: 10.1002/14651858.CD001156.

    PMID: 10796418BACKGROUND

  • 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: 15834056BACKGROUND

  • Leroux JL, Codine P, Thomas E, Pocholle M, Mailhe D, Blotman F. Isokinetic evaluation of rotational strength in normal shoulders and shoulders with impingement syndrome. Clin Orthop Relat Res. 1994 Jul;(304):108-15.

    PMID: 8020202BACKGROUND

  • Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.

    PMID: 5054450BACKGROUND

  • Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

    PMID: 6825348BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Saara Ketola

    Kanta-Häme Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 7, 2006

Study Start

March 1, 2001

Study Completion

July 1, 2006

Last Updated

July 7, 2006

Record last verified: 2006-07

Locations

FI(1)