Operative or Conservative Treatment for Subacromial Impingement Syndrome?

NCT00428870 | Unknown

• 1 other identifier: R04200
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

pShoulder impingement syndrome is common and number of operations done per year is growing. The aim of this study is to compare the value of arthroscopic subacromial decompression (acromioplasty group) vs. diagnostic arthroscopy (control group) vs. supervised exercise therapy (conservative group) on subjects with chronic subacromial impingement syndrome. The results of treatment are measured at 3 months, 6 months, 12 months, 24 months, 5 years and 10 years. Primary outcome measures are pain at rest and activity (VASs) and secondary outcomes are functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change , quality of life assessment (SF-36 and 15D) and costs. At 10 year follow-up, MRI imaging is obtained and the findings compared to baseline imaging.

Conditions

Subacromial Impingement Syndrome

Keywords

Shoulder; impingement; conservative; acromioplasty; arthroscopy

Outcome Measures

Primary Outcomes (2)

• Pain at rest

  Assessed with 10-cm visual analog scales (VASs).

  2 years (primary)

• Pain during activity

  Assessed with 10-cm visual analog scales (VASs).

  2 years (primary)

Secondary Outcomes (4)

• Constant score and Simple Shoulder test

  2 years (primary)

• global assessment of change,

  2 years (primary)

• SF-36 and 15D

  2 years (primary)

• Costs

  2 years (primary)

Study Arms (3)

Arthroscopic acromioplasty

EXPERIMENTAL

Arthroscopic acromioplasty

Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Sham surgery

PLACEBO COMPARATOR

Shoulder arthroscopy without active treatment and subacromial arthroscopy without bursectomy, decompression or other active interventions

Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Conservative treatment

ACTIVE COMPARATOR

Standardized exercise rehabilitation (supervised by physiotherapist)

Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Interventions

Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation) PROCEDURE

Arthroscopic acromioplasty; Conservative treatment; Sham surgery

Eligibility Criteria

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

You may qualify if:

• Subjects are 35 to 65 years of age female or male and have a characteristic history and symptoms of subacromial impingement syndrome at least 3 months.
• Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection).
• They have clinical findings of impingement syndrome; painful arc sign and pain in shoulder abduction, positive findings in two of three isometric shoulder abduction tests (0 degree, 30 degree and external rotation), and positive subacromial injection test.

You may not qualify if:

• Previous surgery of affected shoulder
• Symptomatic osteoarthrosis of acromio-clavicular joint
• Full thickness rotator cuff tear based on clinical findings and MRI
• Long-term cervical syndrome
• Instability of shoulder
• Reluctance to participate in any study groups (i.e. any treatment options of the study)
• Reduced co-operation (drug or alcohol abuse, mental illness)

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

Helsinki University Hospital, Töölö Hospital

Helsinki, HUS, FIN-00029, Finland

Location

Related Publications (5)

• Kanto K, Back M, Ibounig T, Bjorkenheim R, Malmivaara A, Czuba T, Inkinen J, Kalske J, Savolainen V, Sinisaari I, Toivonen P, Taimela S, Jarvinen TLN, Paavola M; Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial. BMJ. 2025 Dec 2;391:e086201. doi: 10.1136/bmj-2025-086201.

  PMID: 41330610 DERIVED

• Back M, Paavola M, Aronen P, Jarvinen TLN, Taimela S; Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up. BMC Musculoskelet Disord. 2021 Oct 19;22(1):889. doi: 10.1186/s12891-021-04768-7.

  PMID: 34666734 DERIVED

• Kanto K, Lahdeoja T, Paavola M, Aronen P, Jarvinen TLN, Jokihaara J, Ardern CL, Karjalainen TV, Taimela S. Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome. BMC Med Res Methodol. 2021 Mar 6;21(1):45. doi: 10.1186/s12874-021-01241-w.

  PMID: 33676417 DERIVED

• Paavola M, Malmivaara A, Taimela S, Kanto K, Inkinen J, Kalske J, Sinisaari I, Savolainen V, Ranstam J, Jarvinen TLN; Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ. 2018 Jul 19;362:k2860. doi: 10.1136/bmj.k2860.

  PMID: 30026230 DERIVED

• Paavola M, Malmivaara A, Taimela S, Kanto K, Jarvinen TL; FIMPACT Investigators. Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome. BMJ Open. 2017 Jun 6;7(5):e014087. doi: 10.1136/bmjopen-2016-014087.

  PMID: 28588109 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Arthroscopy; salicylhydroxamic acid; Conservative Treatment; Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mika Paavola, MD, PhD

  1.1.2003

  PRINCIPAL INVESTIGATOR

• Teppo Jarvinen, MD, PhD

  1.1.2004

  STUDY CHAIR

• Antti Malmivaara, MD, PhD

  1.8.2004

  STUDY CHAIR

• Timo Järvelä, MD, PhD

  1.1.2004

  STUDY CHAIR

• Simo Taimela, MD, PhD

  1.6.2004

  STUDY CHAIR

• Harri Sintonen, Professor

  1.8.2004

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: February 1, 2005
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

FI (1)