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Subacromial Decompression versus Diagnostic Arthroscopy for Shoulder Impingement: Randomised, Placebo Surgery Controlled Clinical Trial.

Paavola, Järvinen·BMJ·2018·189 citations·Shoulder & Elbow
Free Full Text·DOI·PubMed
SummaryAbstract on PubMed →

This Finnish FIMPACT trial is a multicentre, double-blind, placebo surgery controlled RCT in shoulder impingement syndrome. It compares arthroscopic subacromial decompression against diagnostic arthroscopy (sham surgery) and against exercise therapy. The key question: does removing acromial bone actually help, or is the benefit just the placebo of surgery?

Study Snapshot

Design
Multicentre sham-controlled RCT
Blinding: Double-blind
Setting: Three public hospitals in Finland
Funding: Foundations, state funding
Objective
Whether ASD is superior to diagnostic arthroscopy (placebo) for pain in shoulder impingement syndrome
Outcome(s)
Shoulder pain VAS at rest and on arm activity at 24 months
Subjects
210 patients
  • 59ASD
  • 63Sham
  • 71Exercise
Inclusion
  • Age 35-65 years
  • Subacromial pain over 3 months
  • Refractory to conservative treatment
Exclusion
  • Full thickness rotator cuff tear
  • AC joint osteoarthritis
  • Substantial calcific deposits or other intra-articular pathology
Follow-up
24 months
Statistics
Mixed model repeated measuresGEE logistic regressionIntention to treat

Key Findings

  • At 24 months, ASD was no better than placebo surgery for pain at rest (-4.6 points, P=0.18) or on activity (-9.0 points, P=0.054). Both differences fell well below the 15-point clinical threshold, meaning decompression added nothing over simply looking inside the joint.
  • Both surgical groups improved dramatically from baseline (ASD 36-55 point gains, sham 31-47 point gains). This tells you the improvement patients feel is driven by placebo and natural history, not by shaving the acromion.
  • Blinding worked: only 42% of sham patients and 39% of ASD patients correctly guessed placebo (P=0.85). You can trust the null result is not from unblinded patient expectations.
  • ASD beat exercise therapy statistically (VAS on activity -12.0, P=0.008) but the difference stayed below the 15-point MCID. This apparent edge was biased because 12% of surgical patients with likely poor prognosis were excluded before randomisation, with no matching exclusions in the exercise arm.
  • Symptom-driven unblinding was equal between groups (6/59 ASD vs 9/63 sham, P=0.49). Real decompression did not reduce the number of patients who stayed severe enough to need their allocation revealed.
  • Adverse events were few and similar. Frozen shoulder occurred in 3 ASD, 1 sham, and 2 exercise patients, with no difference in serious complications between arms.
Board PearlSubacromial decompression is no better than placebo surgery for shoulder impingement at 24 months, so its routine use is not supported.

Clinical Relevance

When a patient with classic impingement pain asks whether decompression will fix them, this trial says the operation itself adds nothing over looking inside the joint. Both surgical groups improved by 30 to 55 VAS points, but the difference between real and sham surgery was tiny and statistically null. The benefit patients feel is placebo plus natural history, not acromial bone removal.

The design is the teaching point: without a sham surgical arm, you cannot separate the mechanical effect of an operation from the powerful placebo effect of undergoing surgery. This is why earlier unblinded trials misleadingly favoured ASD. The FIMPACT and concurrent CSAW trials together form the evidence base that shifted guidelines away from routine subacromial decompression.

Practically: treat impingement with a supervised exercise program first, and do not promise that decompression will outperform it.

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|

Subacromial Decompression versus Diagnostic Arthroscopy for Shoulder Impingement: Randomised, Placebo Surgery Controlled Clinical Trial.

Paavola, Järvinen·BMJ·2018·189 citations·Shoulder & Elbow
Free Full Text·DOI·PubMed
SummaryAbstract on PubMed →

This Finnish FIMPACT trial is a multicentre, double-blind, placebo surgery controlled RCT in shoulder impingement syndrome. It compares arthroscopic subacromial decompression against diagnostic arthroscopy (sham surgery) and against exercise therapy. The key question: does removing acromial bone actually help, or is the benefit just the placebo of surgery?

Study Snapshot

Design
Multicentre sham-controlled RCT
Blinding: Double-blind
Setting: Three public hospitals in Finland
Funding: Foundations, state funding
Objective
Whether ASD is superior to diagnostic arthroscopy (placebo) for pain in shoulder impingement syndrome
Outcome(s)
Shoulder pain VAS at rest and on arm activity at 24 months
Subjects
210 patients
  • 59ASD
  • 63Sham
  • 71Exercise
Inclusion
  • Age 35-65 years
  • Subacromial pain over 3 months
  • Refractory to conservative treatment
Exclusion
  • Full thickness rotator cuff tear
  • AC joint osteoarthritis
  • Substantial calcific deposits or other intra-articular pathology
Follow-up
24 months
Statistics
Mixed model repeated measuresGEE logistic regressionIntention to treat

Key Findings

  • At 24 months, ASD was no better than placebo surgery for pain at rest (-4.6 points, P=0.18) or on activity (-9.0 points, P=0.054). Both differences fell well below the 15-point clinical threshold, meaning decompression added nothing over simply looking inside the joint.
  • Both surgical groups improved dramatically from baseline (ASD 36-55 point gains, sham 31-47 point gains). This tells you the improvement patients feel is driven by placebo and natural history, not by shaving the acromion.
  • Blinding worked: only 42% of sham patients and 39% of ASD patients correctly guessed placebo (P=0.85). You can trust the null result is not from unblinded patient expectations.
  • ASD beat exercise therapy statistically (VAS on activity -12.0, P=0.008) but the difference stayed below the 15-point MCID. This apparent edge was biased because 12% of surgical patients with likely poor prognosis were excluded before randomisation, with no matching exclusions in the exercise arm.
  • Symptom-driven unblinding was equal between groups (6/59 ASD vs 9/63 sham, P=0.49). Real decompression did not reduce the number of patients who stayed severe enough to need their allocation revealed.
  • Adverse events were few and similar. Frozen shoulder occurred in 3 ASD, 1 sham, and 2 exercise patients, with no difference in serious complications between arms.
Board PearlSubacromial decompression is no better than placebo surgery for shoulder impingement at 24 months, so its routine use is not supported.

Clinical Relevance

When a patient with classic impingement pain asks whether decompression will fix them, this trial says the operation itself adds nothing over looking inside the joint. Both surgical groups improved by 30 to 55 VAS points, but the difference between real and sham surgery was tiny and statistically null. The benefit patients feel is placebo plus natural history, not acromial bone removal.

The design is the teaching point: without a sham surgical arm, you cannot separate the mechanical effect of an operation from the powerful placebo effect of undergoing surgery. This is why earlier unblinded trials misleadingly favoured ASD. The FIMPACT and concurrent CSAW trials together form the evidence base that shifted guidelines away from routine subacromial decompression.

Practically: treat impingement with a supervised exercise program first, and do not promise that decompression will outperform it.

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