Paavola, BMJ 2018 - Subacromial Decompression versus Diagnostic Arthroscopy for Shoulder Impingement: Randomised, Placebo Surgery Controlled Clinical Trial - Article Summary

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

Paavola, Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators, et al.·BMJ·2018·189 citations·RCT

Free Full Text·DOI·PubMed

Purpose

To assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting.

Methods

Design: Multicentre, three group, randomised, double blind, sham controlled trial.

Setting: Orthopaedic departments at three public hospitals in Finland.

Participants: 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.

Interventions: ASD, diagnostic arthroscopy (placebo control), and exercise therapy.

Main Outcome Measures: Shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.

Results

In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months.
The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity.
In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD but the mean differences did not exceed the pre-specified minimal clinically important difference.

Conclusions

In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.

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

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

Paavola, Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators, et al.·BMJ·2018·189 citations·RCT

Free Full Text·DOI·PubMed

Purpose

Methods

Design: Multicentre, three group, randomised, double blind, sham controlled trial.

Setting: Orthopaedic departments at three public hospitals in Finland.

Participants: 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.

Interventions: ASD, diagnostic arthroscopy (placebo control), and exercise therapy.

Results

In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months.
The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity.
In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD but the mean differences did not exceed the pre-specified minimal clinically important difference.

Conclusions

In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.

Purpose

Methods

Design: Multicentre, three group, randomised, double blind, sham controlled trial.

Setting: Orthopaedic departments at three public hospitals in Finland.

Participants: 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.

Interventions: ASD, diagnostic arthroscopy (placebo control), and exercise therapy.

Results

In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months.
The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity.
In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD but the mean differences did not exceed the pre-specified minimal clinically important difference.

Conclusions

In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.

Purpose

Methods

Design: Multicentre, three group, randomised, double blind, sham controlled trial.

Setting: Orthopaedic departments at three public hospitals in Finland.

Participants: 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.

Interventions: ASD, diagnostic arthroscopy (placebo control), and exercise therapy.

Results

In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months.
The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity.
In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD but the mean differences did not exceed the pre-specified minimal clinically important difference.

Conclusions

In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.