Advanced

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement : randomised, placebo surgery controlled clinical trial

Paavola, Mika ; Malmivaara, Antti ; Taimela, Simo ; Kanto, Kari ; Inkinen, Jari ; Kalske, Juha ; Sinisaari, Ilkka ; Savolainen, Vesa ; Ranstam, Jonas LU and Järvinen, Teppo L.N. (2018) In British Medical Journal 362. p.1-11
Abstract

OBJECTIVE: 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. 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)... (More)

OBJECTIVE: 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. 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 (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). 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. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group. CONCLUSIONS: In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months. TRIAL REGISTRATION: Clinicaltrials.gov NCT00428870.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
British Medical Journal
volume
362
article number
k2860
pages
1 - 11
publisher
BMJ Publishing Group
external identifiers
  • pmid:30026230
  • scopus:85054878337
ISSN
0959-8138
DOI
10.1136/bmj.k2860
language
English
LU publication?
yes
id
502c8f2c-076b-4e0f-856d-8d82553808bf
date added to LUP
2019-06-24 14:39:36
date last changed
2020-10-20 03:56:20
@article{502c8f2c-076b-4e0f-856d-8d82553808bf,
  abstract     = {<p>OBJECTIVE: 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. 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 (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). 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. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group. CONCLUSIONS: In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months. TRIAL REGISTRATION: Clinicaltrials.gov NCT00428870.</p>},
  author       = {Paavola, Mika and Malmivaara, Antti and Taimela, Simo and Kanto, Kari and Inkinen, Jari and Kalske, Juha and Sinisaari, Ilkka and Savolainen, Vesa and Ranstam, Jonas and Järvinen, Teppo L.N.},
  issn         = {0959-8138},
  language     = {eng},
  month        = {07},
  pages        = {1--11},
  publisher    = {BMJ Publishing Group},
  series       = {British Medical Journal},
  title        = {Subacromial decompression versus diagnostic arthroscopy for shoulder impingement : randomised, placebo surgery controlled clinical trial},
  url          = {http://dx.doi.org/10.1136/bmj.k2860},
  doi          = {10.1136/bmj.k2860},
  volume       = {362},
  year         = {2018},
}