Operative or Conservative Treatment for Subacromial Impingement Syndrome?

Arthroscopic Decompression Versus Diagnostic Arthroscopy Without Subacromial Decompression Versus Supervised Exercise Therapy in Treatment of Subacromial Impingement Syndrome. A Blinded Randomized Controlled Trail.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

Detailed Description

Applicant information:

Name: Mika Paavola, MD, PhD Address: Helsinki University Central Hospital, Töölö Hospital, Topeliuksenkatu 5, P.O. Box 266, FIN-00029 HUS, Finland Tel: +358 50 523 8382 Fax: +358 9 471 87481 Email: mika.paavola@hus.fi

Trial record details:

Protocol / serial number: N/A Title: Arthroscopic decompression versus diagnostic arthroscopy without subacromial decompression versus supervised exercise therapy in treatment of subacromial impingement syndrome. A blinded randomized controlled trail.

Acronym: N/A Study hypothesis: Operative and diagnostic arthroscopy is equally effective as conservative treatment (supervised exercise therapy) alone for subacromial impingement syndrome.

Research ethics review: Ethics committee approval from the Ethics Committee of the Hospital Districts of Pirkanmaa, date 28.12.2004 (ETL code R04200) Study design: Randomized controlled trial

Participants - inclusion criteria: In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfill the following inclusion criteria:

1. 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.
2. Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection).
3. 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.

Participants - exclusion criteria:

1. Previous surgery of affected shoulder
2. Symptomatic osteoarthrosis of acromio-clavicular joint
3. Full thickness rotator cuff tear based on clinical findings and MRI
4. Long-term cervical syndrome
5. Instability of shoulder
6. Reluctance to participate in any study groups (i.e. any treatment options of the study)
7. Reduced co-operation (drug or alcohol abuse, mental illness) Anticipated start date: 1/10/2005 Anticipated end date: 31/12/2009 Target number of participants: 210 Disease: Chronic (> 3 months before inclusion) shoulder subacromial pain syndrome.

Interventions: 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 shoulder arthroscopy is done three to six week after the baseline clinical examination by one of the seven experienced shoulder orthopaedists. At first, arthroscopy of shoulder joint is performed in patients of acromioplasty group and control group, and all pathological findings are recorded. Thereafter, arthroscopy of subacromial space is carried out. In control group, subacromial decompression is not done. In patients of supervised exercised therapy group, 3 months period of exercise therapy with home exercises, supervised by experienced physiotherapist, is initiated.

Primary outcome(s): Pain at rest and activity assessed with 10-cm visual analog scales (VASs). Participants assess maximum pain in the previous two days at rest and at exertion. Main follow-up time-point is 24 months after initiation of the treatment (i.e. operative treatment or first visit at the physiotherapist. Other time-points when the main outcome is measured are before the randomization, three month follow-up, six month follow-up and 12 month follow-up.

Secondary outcome(s): Functional assessment of the shoulder with Constant score and Simple Shoulder test (SST), global assessment of change [symptom questionnaire and subjective contentment (10-cm visual analog scales)], quality of life assessment (SF-36 and 15D).

Sources of funding: Finnish Office for Health Technology Assessment (National Research and Development Centre for Welfare and Health of Finland) and Sigrid Juselius Foundation Main sponsor information Name: Finnish Office for Health Technology Assessment Address: National Research and Development Centre for Welfare and Health (STAKES) - P.O. Box 220, FI-00531 Helsinki, Lintulahdenkuja 4, Finland Contact person

Contact information:

Name: Mika Paavola Address: Department of Orthopedics and Traumatology, Töölö hospital, Helsinki University Central Hospital P.O. Box 266 00029 HUS Helsinki Finland Tel: +358-50-5238382 Email: mika.paavola@hus.fi and mika.paavola@fimnet.fi Privacy level: Show all contact details

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • HUS
    • Helsinki, HUS, Finland, FIN-00029
      • Helsinki University Hospital, Töölö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

In the first phase orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of Helsinki University Hospital, (either Töölö Hospital or Jorvi Hospital) or District Hospital of Tampere (Hatanpää Hospital) and fulfill the following inclusion criteria:

1. 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.
2. Symptoms have no relieved with appropriate conservative treatment (i.e. physiotherapy, NSAIDs and subacromial corticosteroid injection).
3. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arthroscopic acromioplasty	Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)
PLACEBO_COMPARATOR: Sham surgery; 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)
ACTIVE_COMPARATOR: Conservative treatment; Standardized exercise rehabilitation (supervised by physiotherapist)	Procedure: Arthroscopic acromioplasty or arthroscopy alone (sham) or conservative treatment (rehabilitation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score and Simple Shoulder test	Functional assessment of the shoulder	2 years (primary)
global assessment of change,	Likert scale	2 years (primary)
SF-36 and 15D	Quality of life assessment	2 years (primary)
Costs	Resource use	2 years (primary)

Collaborators and Investigators

• Sponsor: University of Helsinki
• Investigators: Principal Investigator: Mika Paavola, MD, PhD, 1.1.2003; Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: January 29, 2007
• First Submitted That Met QC Criteria: January 29, 2007
• First Posted (ESTIMATE): January 30, 2007

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Shoulder; arthroscopy; conservative; impingement; acromioplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: R04200