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RCT
ACE Report #8454

Arthroscopic acromioplasty may not be efficacious for shoulder impingement syndrome


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Which patients do not recover from shoulder impingement syndrome, either with operative treatment or with nonoperative treatment?

Acta Orthop. 2015 Dec;86(6):641-6

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Synopsis

140 patients with shoulder impingement syndrome were randomized to either a supervised exercise program alone or to arthroscopic acromioplasty followed with a similar exercise program. The purpose of this subgroup analysis study was to determine which patients (from either the arthroscopic acromioplasty and exercise therapy group, or the group treated solely with exercise therapy) are effectively treated for shoulder impingement syndrome when followed up at 2 and 5 years. Findings showed similar results between the patients who underwent operative treatment and the group that underwent conservative treatment. Furthermore, arthroscopic acromioplasty did not appear to improve results in patients who were originally allocated to exercise therapy alone and were unsatisfied with outcome following conservative management.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Professor of medicine Y. T. Konttinen from Helsinki University Central Hospital
Conflicts:
None disclosed

Risk of Bias

4/10

Reporting Criteria

16/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

1/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Shoulder impingement syndrome is a common source of shoulder pain and functional deficit. Both operative and non-operative methods have been used to treat shoulder impingement syndrome. Despite previous literature suggesting that arthroscopic acromioplasty may not offer any significant advantages over exercise therapy, the use of arthroscopic acromioplasty in the treatment of shoulder impingement has been increasing over the past years. . This subgroup analysis was conducted to identify the individuals within the sample population that would benefit from operative treatment.

What was the principal research question?

What differences, if any, exist between subgroups of patients treated with acromioplasty and exercise therapy versus exercise therapy alone in the management of shoulder impingement syndrome, as assessed over a 5-year follow-up period?

Study Characteristics -
Population:
140 patients (18-60 years of age) with shoulder impingement syndrome. To be eligible for inclusion, patients must have symptoms that were unresponsive to previous nonoperative treatments, as well as a lack of previous shoulder surgery. (n=140; Mean age: 47 years; 52M/88F)
Intervention:
Combined group: patients in this group underwent combined treatment of arthroscopic acromioplasty followed by a structured exercise program. An arthroscopic decompression was initially performed for these patients. All patients were under regional anesthesia, and the operation was performed using a burr drill. (n=70; Mean age: 46.4 [Range: 23.3 to 60]; 41F/29M; 57 completed follow-up)
Comparison:
Exercise therapy group: patients randomized to this group only took part in the supervised exercise program. (n=70; Mean age: 47.8 [Range: 26.8 to 59.2]; 47F/23M; 52 completed follow-up)
Outcomes:
The primary outcome of this study was self-reported pain measured by a visual analogue scale (VAS). The number of pain-free patients was also determined by the criteria of having a VAS score of 3 or less from a scale of 0 to 10. Secondary outcomes consisted of disability measurements, working ability, VAS pain at night, shoulder disability questionnaire (SDQ) score and a number of reported days with pain before follow-up.
Methods:
RCT; single-center
Time:
Follow up was conducted at 2 and 5 years after randomization.

What were the important findings?

  • Both the operative and non-operative groups reported significant improvements compared to baseline for self-reported pain, disability, working ability, pain at night, SDQ score and reported days with pain. Outcomes were similar between the groups.
  • Patients who were dissatisfied in the non-operative group and later received operative treatment reported worse values compared to patients in the other groups.
  • Overall in the entire cohort, 86 patients were pain-free and 48 patients reported pain (>3 on a visual analog scale) at 2-year follow-up. At 5 years, 82 patients were pain-free and 27 patients reported pain.
  • A number of factors were identified as having a statistically significant impact on pain. At 2-year follow-up factors included: living alone (Odds ratio 3.29 [95%CI 1.39-7.78]), lack of professional education (OR 3.67 [95%CI 1.20-11.2]), moderate load lifted per day (20-100kg) (OR 4.36 [95%CI 1.38-13.8]), and sick leave prior to randomization exceeding 2 weeks (OR 2.52 [95%CI 1.10-10.22]). At 5-year follow-up factors included: living alone (OR 2.77 [95%CI 1.02-7.55]), moderate-heavy load lifted per day (100-500kg) (OR 4.35 [95%CI 1.13-18.1]), and sick leave prior to randomized exceeding 2 weeks (OR 3.83 [95%CI 1.35-10.9]).
  • Overall satisfaction at work demonstrated a statistically significant effect on pain at 2-year follow-up (p=0.01), and requirement/challenges at work demonstrated a statistically significant effect on pain at 5 years (p=0.01).

What should I remember most?

In the treatment of shoulder impingement syndrome, similar results for self-reported pain, disability, working ability, pain at night, SDQ score, and reported days with pain were demonstrated between arthroscopic acromioplasty with exercise therapy compared to exercise therapy alone. Patients initially in the exercise therapy group that later wanted arthroscopic acromioplasty did not show postoperative improvement.

How will this affect the care of my patients?

Based on the results of this analysis, arthroscopic acromioplasty may not offer any significant difference in clinical outcome when compared to supervised exercise therapy, or in cases of pursued surgery following supervised exercise therapy. The authors also reported that there does not appear to be a specific subgroup of patients to guide the decision between supervised exercise therapy and arthroscopic acromioplasty. Future research should consider possible patient subgroups as enrollment criteria in order to prospectively analyze outcomes between supervised exercise therapy and arthroscopic acromioplasty with a more narrow focus, as opposed to a secondary analysis with low sample sizes for multiple variables.

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