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Volume:2 Issue:2 Number:196 ISSN#:2563-5476
RCT
ACE Report #345

Dilatation combined with steroid injections equivalent to steroid in adhesive capsulitis


How to Cite

OrthoEvidence. Dilatation combined with steroid injections equivalent to steroid in adhesive capsulitis. ACE Report. 2013;2(2):196. Available from: https://myorthoevidene.com/AceReport/Report/345

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

Hydrodilatation, corticosteroids and adhesive capsulitis: A randomized controlled trial

BMC Musculoskelet Disord. 2008 Apr 19;9:53.

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Synopsis

76 patients diagnosed with adhesive capsulitis, having predominantly 1 shoulder pain for >3 months in the last 2 years, were randomized to undergo hydrodilatation with corticosteroid injection or just corticosteroid intra-articular injection. This study aimed to compare the clinical results between techniques. At 6 weeks, no major significant between-group differences in most of the outcome measures were recorded. There was a similar degree of improvement from baseline in both of the treatment groups, hence questioning the role of hydrodilation in management of adhesive capsulitis.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Research Council of Norway, the University of Oslo and Ulleval University Hospital
Conflicts:
None disclosed

Risk of Bias

6/10

Reporting Criteria

17/21

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.

2/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

5/5

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?

Evidence has suggested that the etiology of patients with adhesive capsulitis may result from the contractions of the shoulder and intraarticular adhesions. Hydrodilatation of the glenohumeral joint has thus been advocated for improvement of shoulder pain and range of motion in these patients. However, evidence remains inconclusive due to methodological issues. This study investigated the effect of hydrodilatation on the overall treatment effects of a combined dilatation and steroid injection procedure.

What was the principal research question?

Are there clinical differences between patients receiving dilatation (DIL) with a corticosteroid and patients receiving Injection (INJ) of a corticosteroid in the treatment of adhesive capsulitis?

Study Characteristics -
Population:
76 patients (18-70) with diagnosis of adhesive capsulitis, pain in one shoulder lasting >3 months, and limited passive movement in glenohumeral joint >30 degrees (versus opposite shoulder) in 2 of: forward flexion, abduction, external rotation.
Intervention:
Dilatation (DIL): Injection was comprised of: 4 ml of contrast dye, 2 ml triamcinolone acetonide, 4 ml local anesthetic and 10 ml physiological saline. Injection into the joint was performed slowly, and was paused upon resistance before continuing. This technique facilitated gradual joint distension and rupture. 3 injections were administered at two-week intervals (n=39; Mean age: 52+/-7; 26 females)
Comparison:
Injection (INJ): Following location of desired position (with fluoroscopy), 3-4 mL of contrast dye was injected, followed by 2 mL triamcinolone acetonide, and 3-4 mL of local anesthetic (bupivacaine, hydrochloride, Marcain 5mg/mL, Astra-Zeneca). Patients were administered 3 injections at two-week intervals. (n=37; Mean age: 51+/-6; 19 females)
Outcomes:
Outcomes included the Shoulder Pain and Disability Index (SPADI) and measurement of active and passive range of motion (AROM and PROM)in four directions: forward flexion, abduction from standing, external/internal rotation from 45 deg abduction (supine position).
Methods:
RCT: Prospective, Single-Center, Open trial
Time:
Patients were followed up 6 weeks after last injection.

What were the important findings?

  • Both groups had comparable clinical improvements in Shoulder Pain and Disability Index (SPADI), passive range of motion (PROM) and active range of motion (AROM) from baseline (p>0.05).
  • The mean difference in SPADI scores from baseline was 3 points (95% CI: -5 to 11) favouring the DIL group (p>0.05).
  • 13 and 9 patients in the INJ and DIL groups, respectively, reported flushing or disturbances with heat regulation. 20 and 14 patients, respectively, reported pain upon injection.

What should I remember most?

Similar improvements from baseline in Shoulder Pain and Disability Index (SPADI), passive range of motion (PROM) and active range of motion (AROM) were observed in both the hydrodilatation and control groups.

How will this affect the care of my patients?

The results indicated that hydrodilatation did not provide any additional clinical benefits in patients with adhesive capsulitis, but may have an important treatment effect in some selected cases. Therefore, there is a need for future trials investigating the long-term effects of hydrodilatation.

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