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Volume:2 Issue:6 Number:93 ISSN#:2563-5476
RCT
ACE Report #5014

Adhesive capsulitis: Pain & disability improved similarly with 20mg & 40mg corticosteroid


How to Cite

OrthoEvidence. Adhesive capsulitis: Pain & disability improved similarly with 20mg & 40mg corticosteroid. ACE Report. 2013;2(6):93. Available from: https://myorthoevidene.com/AceReport/Report/5014

Study Type:Randomized Trial
OE Level Evidence:1
Journal Level of Evidence:N/A

Optimal dose of intra-articular corticosteroids for adhesive capsulitis: A randomized, triple-blind, placebo-controlled trial

Am J Sports Med. 2013 May;41(5):1133-9. doi: 10.1177/0363546513480475. Epub 2013 Mar 18

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Synopsis

63 patients were randomized to determine the effect of varying doses of corticosteroid injections in the treatment of adhesive capsulitis. Participants were allocated to groups of high-dose triamcinolone (40mg), low-dose triamcinolone (20mg), or placebo (control) (1% lidocaine). Results after 12 weeks indicated that pain and disability were more significantly improved with both dosages of corticosteroid compared to control, but there was no difference between 20mg and 40mg triamcinolone. Corticosteroid injections also had a beneficial effect on passive range of motion in flexion, abduction, and internal rotation

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Research fund of Ajou University School of Medicine
Conflicts:
None disclosed

Risk of Bias

8/10

Reporting Criteria

19/20

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.

4/4

Randomization

3/4

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?

Although intra-articular injections of corticosteroid have been and remain a mainstay in the treatment of adhesive capsulitis, there is little evidence available to guide clinician decision-making with respect to dosage. It has been suggested that the efficacy of steroid injections conforms to a dose-dependent relationship, with increasing dose leading to a more favourable outcome. Yet, simultaneously, the severity of cartilage damage linked to corticosteroid injection is also thought to be manifested through the same dose dependency. Therefore, it has become crucial to determine the optimal steroid dosage to use in the treatment of adhesive capsulitis.

What was the principal research question?

What was the comparative efficacy of 20mg triamcinolone acetonide, 40mg triamcinonlone acetonide, and placebo in adhesive capsulitis treatment?

Study Characteristics -
Population:
53 patients (aged 20-70) with stage 2 adhesive capsulitis (freezing stage as described by Hannafin and Chiaia). Other criteria for inclusion were restricted passive motion of greater than 30 degrees, pain lasting for at least one month, and average daily pain intensity of 3 points or greater on a 10cm visual analog scale.
Intervention:
High-dose steroid group: Patients received a single, utltrasound-guided intra-articular injection of 4mL of 10mg/mL triamcinolone acetonide and 1mL of 1% lidocaine to the glenohumeral joint from the posterior side of the shoulder (Mean age: 54.2; n=20) Low-dose steroid group: Patients received a single, ultrasound-guided intra-articular injection of 2mL of 10mg/mL triamcinolone acetonide and 3mL of 1% lidocaine to the glenohumeral joint from the posterior side of the shoulder (Mean age: 52.2; n=20)
Comparison:
Placebo group: Patients received a single, ultrasound-guided intra-articular injection of 5mL of 1% lidocaine to the glenohumeral joint from the posterior side of the shoulder (Mean age: 55.9; n=13, 11 completed follow-up)
Outcomes:
Primary outcome was measurement through the Shoulder Pain and Disability Index (SPADI). Secondary outcome measures included a visual analog scale (VAS 10-cm) for shoulder pain, and passive range of motion assessed with goniometer.
Methods:
RCT, Triple-blind (participants, injection operator, and evaluator), Placebo-controlled, Dose-comparative
Time:
Evaluation was conducted 1, 3, 6, and 12 weeks postinjection

What were the important findings?

  • SPADI scores were reduced from 37.9 (SD 14.2) at baseline to 14.1 (SD 12.4) at 12 weeks in the high-dose group, 37.6 (SD 13.7) to 18.3 (SD 14.0) in the low-dose group, and 44.2 (SD 12.2) to 37.1 (SD 10.4) in the placebo group. Improvements in both the high-dose and low-dose steroid groups were significant compared to placebo (P<0.001 and P=0.001, respectively), although the difference between steroid groups was not significant (P=0.826).
  • Marked reductions in VAS pain were observed for the steroid groups; the high-dose group from 5.2 (SD 1.7) at baseline to 2.4 (SD 1.7) at 12 weeks, and the low-dose group from 4.9 (SD 1.3) to 2.4 (SD 1.3). The difference between these two group was not significant (P=0.999). Compared to placebo (reduction from 5.5 to 4.6), both steroid groups were observed to have a significantly greater reduction (High-dose: P<0.001; Low-dose: P=0.001).
  • Flexion, abduction, and internal rotation were significantly better in the high- and low-dose groups compared to placebo group (all P<0.005). The difference between the steroid groups was not significant for these measurements, however (P=0.485, 0.092, and 0.495, respectively).
  • The group-by-time interactions for extension and external rotation were not significant (P=0.331 and 0.094, respectively), however the group-by-time interactions for SPADI (P=0.007), VAS (P=0.004), flexion (P=0.024), abduction (P<0.001) and internal rotation (P=0.027) were all significant.
  • Facial flushing was observed in 3 high-dose participants and 1 low-dose participant. Dizziness due to a vasovagal reaction occurred in 1 patient of the placebo group and 1 in the low-dose group. These were the only complications reported.

What should I remember most?

Injection of either 20mg or 40mg triamcinolone acetonide led to significantly reduced pain and disability compared to a control injection in the treatment of adhesive capsulitis. Furthermore, improved range of motion was observed with the corticosteroid injections. There were no differences in outcomes based on dose of triamcinolone acetonide received, and neither dose was associated with any serious adverse event.

How will this affect the care of my patients?

At 12 weeks post injection there appears to be no difference between a lower (20mg) and a higher dose (40mg) of triamcinolone. Given the lack of difference, a lower dose may be considered to avoid any potential complications that may exist with higher doses (even though the study found none). However, further investigation with a larger cohort of patients is required to confirm the efficacies of both high- and low-dose corticosteroid injections. Long-term effect of single injections should also be determined in future studies.

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