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Author Verified
RCT
ACE Report #5854

Similar efficacy between intra- and periarticular injections for acromioclavicular joint


Study Type:Randomized Trial
OE Level Evidence:1
Journal Level of Evidence:2

Intra-articular versus periarticular acromioclavicular joint injection: a multicenter, prospective, randomized, controlled trial

Arthroscopy. 2013 Dec;29(12):1903-10. doi: 10.1016/j.arthro.2013.08.027. Epub 2013 Oct 18

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Synopsis

101 patients (106 shoulders) were randomized to investigate the efficacy of either an intra-articular injection or periarticular injection in the treatment of symptomatic acromioclavicular joints. Outcome measurements of pain and function were assessed up to 3 weeks post-injection. The results indicated that either injection provided similar, significant improvements in pain and function. There was no difference observed between groups, with the exception that less pain during the crossover arm test (COAT) was reported among participants treated with an intra-articular injection.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
Vienna Medical School (non-industry); Medical Scientific Fund of the Mayor of the City of Vienna (non-industry), Gebro Pharma (industry); Merck, Sharp & Dohme (industry)
Conflicts:
None disclosed

Risk of Bias

8/10

Reporting Criteria

17/20

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

2/4

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?

Symptomatic acromioclavicular joints represent one of the most common presentations of shoulder pain and discomfort. Typically, injections of corticosteroid and local anaesthetic into the intra-articular space are used in acute cases where contraindications are absent. Despite easy localization of the joint, misinjection into the periarticular space is not uncommon. To improve accuracy of the injection, ultrasound guidance can be employed. However, there has been debate about whether the added practice of ultrasonographic guidance for injections is necessary to elicit clinically relevant effects.

What was the principal research question?

Is there a clinically relevant benefit of injections to the intra-articular space versus periarticular space in treatment of symptomatic acromioclavicular joints, measured up to 3 weeks following injection?

Study Characteristics -
Population:
101 patients (106 shoulders) with a symptomatic acromioclavicular (AC) joint, defined as pain at the AC joint above 4 on a visual analog scale (0-10) for more than 4 weeks
Intervention:
Intraarticular injection: Patients were treated with an ultrasound-guided injection of lidocaine hydrochloride (Gebro Pharma) and 1mL of betamethasone (SP Labo) into the intra-articular space using a ventral approach (Mean age: 53.92 (+/- 13.80)) (n=53 shoulders)
Comparison:
Periarticular injection: Patients were treated with an ultrasound-guided injection of lidocaine hydrochloride (Gebro Pharma) and 1mL of betamethasone (SP Labo) periarticularly (Mean age: 52.34 (+/- 11.89)) (n=53 shoulders)
Outcomes:
A visual analog scale was used to assess pain experienced under local pressure (VAS-p) and at night (VAS-n). The Constant-Murley Score (CMS) was used to assess functional outcome. The Crossover Arm Test (COAT) was another measure of pain, with (-) denoting no pain, and (+)-(+++) increasing intensity of pain.
Methods:
RCT, Assessor-blind, Patient-blind, Multicenter (7 centers), Prospective
Time:
Outcomes were assessed at 1 hour, 1 week, and 3 weeks post-injection

What were the important findings?

  • Injection into either location (intra-articular and periarticular) was associated with highly statistically significant improvement in all outcome measures (P<0.0001).
  • The CMS for the entire study population increased from 54.54 (SD 16.32) to 73.33 (SD 17.24) at the 3 week follow-up. The difference between groups was not significant (P=0.2408). Factors of age and height had a significant effect on reduction of score.
  • Mean decrease in VAS-p scores for the study population was from 5.76 (SD 2.00) to 2.68 (SD 2.34) after 3 weeks, with no significant differences between groups (P=0.608). Factors of height and previous trauma had a significant effect on score. A 1-cm decrease in height was associated with a mean 0.06-point increase (95%CI 0.02, 0.09; P=0.0007) on the VAS-p. Lower scores were observed for patients who had previous shoulder trauma compared to patients with no trauma in their history.
  • VAS-n scores improved in the study population from 5.22 (SD 2.27) to 2.42 (SD 2.31) after 3 weeks, without significant difference between treatment groups.
  • In the intra-articular group, COAT values decreased from 5.27 (SD 2.35) at baseline to 2.24 (SD 2.25) after 3 weeks. In the periarticular group, COAT scores decreased from 5.18 (SD 2.21) at baseline to 2.61 (SD 2.37) after 3 weeks. The decrease on the COAT was observed to be significantly greater in the intra-articular group compared to periarticular group (P=0.168). A 1-cm decrease in height was associated with a 0.02-point decrease (95%CI 0.01, 0.03; P=0.0186) in COAT score, indicating shorter patients had less pain on the COAT.
  • Five adverse events were recorded; 2 in the intra-articular group and 3 in the perarticular group. These were local hematoma (3 cases), increased pain (1 case), and reddening at the puncture area (1 case). All resolved without additional intervention.

What should I remember most?

Intra-articular and periarticular injection of corticosteroid and local anaesthetic produced similar, significant improvements in pain and function after 3 weeks among patients with symptomatic acromioclavicular joint. The only difference displayed between groups was that pain during the crossover arm test was significantly lower in patients who were treated with an intra-articular injection.

How will this affect the care of my patients?

The results of this study illustrate that intra-articular and periarticular injections appear to have similar efficacy in alleviating a symptomatic acromioclavicular joint. There has been suggestion that cartilage damage can potentially occur through intra-articular injections, triggering the development of osteoarthritis. As the follow-up period of this study was not adequate in determining the potential increase in osteoarthritis development from intra-articular injections, future research should be conducted to study this potential difference in the outcome of injection location.

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