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RCT
ACE Report #9021

Efficacy of corticosteroid injection, with and without distension, for adhesive capsulitis


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

Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care

BMC Musculoskelet Disord. 2016 May 26;17(1):232.

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Synopsis

106 patients with adhesive capsulitis were randomized to one of three groups to determine which mode of conservative therapy - corticosteroid injections with distension, corticosteroid injections only, or treatment-as-usual (verbal education, use of other conservative therapy) - was associated with the greatest improvement in shoulder pain, function, and range of motion on the short-term (4 and 8 weeks) and long-term (12 months). Results demonstrated that patients in both corticosteroid injection intervention groups had significant improvements in pain, function, abduction, internal rotation, and external rotation when compared to the usual treatment group when assessed at 4 and 8 weeks. Long-term improvements in any outcome measure (12 months) between all groups and efficacy between the two intervention groups were comparable when evaluated.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
General Practice Research Fund of The Norwegian Medical Association, Dr. Trygve Gythfeldt Research Fund
Conflicts:
None disclosed

Risk of Bias

6/10

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

2/4

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?

Adhesive capsulitis, also known as "frozen shoulder", is diagnosed as a long-lasting condition characterized by recurrent onset of pain, progressive stiffness, and reduced shoulder range of motion. These symptoms are further associated with interference in activities of daily living and increased dependency by the elderly. Several modes of conservative therapy have been developed to address and mitigate these symptoms (ie. nonsteroidal anti-inflammatory drugs, intraarticular glucocorticosteroid injections, physical therapy, and manipulation under anaesthetic and hydrodilation), however recent study has been largely unsuccessful in finding an optimal treatment modality. Therefore, the aim of this study was to determine the short- and long-term effects of multiple corticosteroid injections with distension, when compared to injection alone or treatment-as-usual.

What was the principal research question?

For patients with adhesive capsulitis, how does conservative treatment with either corticosteroid injections and distension, corticosteroid injections alone, or standard treatment compare in improved pain, disability, and passive range of motion when assessed throughout a 12-month follow-up period?

Study Characteristics -
Population:
106 patients, older than 18 years of age, with clinical evidence of adhesive capsulitis. Patients were required to demonstrate reduced passive range of motion (PROM) by a least 30% in two or more of three shoulder movements (abduction, external rotation, and internal rotation).
Intervention:
Steroid Injection and Lidocaine (IS) group: patients were allocated to treatment with 4 triamcinolone 20 mg injections with Lidocaine 10 mg/mL 3mL only (n=36, 34 completed follow-up; mean age= 52+/-8.3, 21F). Median duration of symptoms was 7.5 months (2.5-18.0). Steroid Injection, Lidocaine, and Saline Distention (ISD) group: patients were allocated to treatment with 4 triamcinolone 20 mg injections with Lidocaine 10 mg/mL 3mL and physiological sodium chloride 9 mg/mL (total injection volume was 8 mL to 20 mL, where limiting factors on injected volume included difficulty in further injection of increase in pain during injection) (n=34, 32 completed follow-up; mean age= 53+/-9.2, 21F). Median duration of symptoms was 7.0 months (3.0-37.0).
Comparison:
Treatment-as usual (TAU) group: patients were referred to other modes of conventional treatment, such as physiotherapy or oral medication, or oral corticosteroid medication. Patients were allowed to receive conservative therapy (including corticosteroid injections) after completion of the 8-week intervention period (n=36, 21 completed follow-up; mean age= 54+/-6.9, 19F). Median duration of symptoms was 6.0 months (3.0-24.0)
Outcomes:
Primary outcome of interest was the shoulder pain and disability index (SPADI, 0 to 100). Pain measured on a 10-point numerical pain rating scale (NPRS, 0 to 10) and passive range of motion (PROM) measured through abduction, internal rotation and external rotation were secondary outcomes of interest.
Methods:
RCT: prospective, assessor-blinded
Time:
Outcomes of interest were evaluated on the first visit and after 4 weeks, 8 weeks, and 12 months.

What were the important findings?

  • Both intervention groups were observed with significant improvement in SPADI when compared to the TAU group at 4 and 8 weeks (IS vs. TAU MD=-20.8 [28.9 to -12.7], p<0.001 | ISD vs. TAU MD= -21.7 [-29.4 to -14.0], p<0.001); significant was not maintained at 12 months. Additionally, differences in SPADI scores between IS and ISD groups were not significant.
  • Both intervention groups were observed with significant improvement in NPRS scores when compared to the TAU group at 4 and 8 weeks (IS vs. TAU MD=-2.0 [-2.8 to -1.1], p<0.001 | ISD vs. TAU MD= -2.2 [-3.0 to -1.4], p<0.001); differences in NPRS scores between IS and ISD groups were not significant.
  • Patients in the IS group (MD=8.3 [2.3 to 14.3]) and the ISD group (MD=12.8 [6.6 to 18.9]) were observed with significantly greater improvement in abduction when compared to the TAU group at 4 and 8 weeks (p=0.01 and p=0.001 respectively).
  • Patients in the IS group (MD=10.8 [5.8 to 15.9]) and the ISD group (MD=11.9 [6.8 to 17]) were observed with significantly greater improvement in internal rotation when compared to the TAU group at 4 and 8 weeks (p=0.001 for both).
  • Patients in the IS group (MD=5.0 [2.8 to 7.2]) and the ISD group (MD=5.1 [2.9 to 7.2]) were observed with significantly greater improvement in external rotation when compared to the TAU group at 4 and 8 weeks (p=0.001 for both).
  • Differences in all measurements of passive range of motion (abduction, internal rotation, and external rotation) were not significant between all three groups, or when intervention groups were compared to the TAU group, at 12 months.
  • 17% and 12% of patients in the IS and ISD group respectively experiences minor transitory side effects (including flushing and after-pain); no other minor or adverse effects were observed.

What should I remember most?

For patients undergoing conservative treatment for adhesive capsulitis, use of corticosteroid injection with or without distension was associated with significantly improved pain, function, and range of motion when compared to the treatment-as-usual (TAU group) at 4 and 8 weeks. However, when assessed at 12 months, outcomes scores were comparable between study groups. Additionally, differences between pain, function and range of motion outcomes never reached statistical significance when the two corticosteroid injection intervention groups were compared throughout the study.

How will this affect the care of my patients?

The results of this study suggest that corticosteroid injection treatment, with or without distention, may provide patients with significant short-term reduction of adhesive capsulitis symptoms when compared to usual treatment. Nevertheless, outcome after 1 year does not appear to differ between treatment option. Further randomized controlled trials are needed to verify consistent short-term benefit of corticosteroid injection, with or without distension, in cases of adhesive capsulitis. Additionally, methods offered in the treatment-as-usual group were heterogenous, with the possibility remaining that there may be differences depending on specific control interventions.

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