RCT
ACE Report #10068

Long term pain relief better with rESWT versus corticosteroid injection for carpal tunnel syndrome


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

Comparison of single-dose radial extracorporeal shock wave and local corticosteroid injection for treatment of carpal tunnel syndrome including mid-term efficacy: a prospective randomized controlled trial

BMC Musculoskelet Disord. 2018 Jan 25;19(1):32

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Synopsis

25 patients with carpal tunnel syndrome were randomized to treatment with either a single session of radial extracorporeal shockwave therapy or a single corticosteroid injection. Primary outcome was the Boston Carpal Tunnel Questionnaire, including both the Symptoms and Functional scores. Patients were assessed at 1, 4, 12, and 24 weeks after treatment. Within-group reductions from baseline in BCTQ scores were significant from 4 weeks to 24 weeks in the rESWT group, in contrast to only 1 week to 4 weeks in the corticosteroid injection group. The reduction in scores from 12 weeks to 24 weeks were significantly greater in the rESWT compared to the corticosteroid injection for each of the BCTQ total score, Symptoms subscore, and Functional subscore.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Faculty of Medicine, Chiang Mai University
Conflicts:
None disclosed

Risk of Bias

7/10

Reporting Criteria

18/21

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.

4/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/5

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?

Carpal tunnel syndrome is a common condition, with a number of studies performed on its incidence in both working and elderly populations. Corticosteroid injections are often administered prior to consideration of surgery, though long-term effectiveness of this option has been questioned. A more recent modality in conservative management is extracorporeal shockwave therapy (ESWT), with particular interest in radial ESWT as opposed to focused ESWT. However, comparative efficacy of rESWT and cortciosteroid injection has not been previously studied in a randomized controlled trial.

What was the principal research question?

In treatment of carpal tunnel syndrome, how does disease-specific pain and function compare between patients administered a single dose of radial extracorporeal shockwave therapy and patients administered a single injection of triamcinolone, assessed over 24-week follow-up?

Study Characteristics -
Population:
25 patients, over the age of 18 years, with mild to moderate carpal tunnel syndrome, based on physical examination and electrodiagnostic examination.
Intervention:
rESWT group: Patients underwent a single session of radial extracorporeal shockwave therapy, with settings of 4 Bar, 15Hz frequency, and 5000 shocks for 3-7 minutes. (n=13; 11 completed) (Mean age: 46+/-9)
Comparison:
Corticosteroid injection group: Injection was performed 1cm proximal to wrist flexion crease, and advanced 1cm to within the flexor retinaculum. Injection was performed using a solution containing 1mL triamcinolone acetonide 10mg and 1mL lidocaine 1%. (n=12; 12 completed) (Mean age: 53+/-12)
Outcomes:
Primary outcome was the Boston Carpal Tunnel Questionnaire Symptom and Functional Score. Secondary outcomes included pain on a visual analog scale and electrodiagnostic parameters, including median peak sensory latency, sensory nerve action potential amplitude, and compound muscle action potential amplitude.
Methods:
RCT
Time:
Follow-up was scheduled for 1, 4, 12 and 24 weeks after treatment. Electrodiagnostic assessment was only performed at 12 weeks after treatment.

What were the important findings?

  • Reduction in total BCTQ score from baseline was statistically significant within the rESWT group after 4, 12, and 24 weeks, and within the corticosteroid injection group after 1 week only. When comparing between groups, the reduction in score from 12 weeks to 24 weeks was significantly greater in the rESWT group compared to the corticosteroid injection group (p=0.015).
  • Reduction in BCTQ Symptom score from baseline was statistically significant within the rESWT group after 4, 12, and 24 weeks, and within the corticosteorid injection group after 1 and 4 weeks. When comparing between groups, the reduction in score from 12 weeks to 24 weeks was significantly greater in the rESWT group compared to the corticosteroid injection group (p=0.015).
  • Reduction in BCTQ Functional score from baseline was statistically significant within the rESWT group after 12 and 24 weeks, and within the corticosteroid injection group at no follow-up time point. When comparing between groups, the reduction in score from 12 weeks to 24 weeks was significantly greater in the rESWT group compared to the corticosteroid injection group (p=0.015).
  • Reduction in VAS pain score from baseline was statistically significant within the rESWT group after 12 and 24 weeks, and within the corticosteroid injection group at no follow-up time point.
  • Both groups demonstrated significant reduction int peak sensory distal latency from baseline to 12 weeks, while neither group demonstrated a significant change in SNAP amplitude, motor distal latency, or CMAP amplitude.

What should I remember most?

In treatment of carpal tunnel syndrome, one session of radial extracorporeal shockwave therapy demonstrated significant reduction in disease-specific pain and functional limitation relative to pre-treatment values after 12 and 24 weeks, and demonstrated significantly greater reduction in disease-specific pain and functional limitation between 12 and 24 weeks when compared to that achieved by a single corticosteroid injection.

How will this affect the care of my patients?

The results of this study suggest that one session of radial extracorporeal shockwave therapy may possess greater therapeutic efficacy for reducing symptomatic pain and functional limitation associated with carpal tunnel syndrome when compared to a single cortciosteroid injection. A particular limitation is the small study size, with data from only 25 patients. Further studies should planned within a large sample of patients. In the current study, differences in efficacy did not appear until 12- to 24-week follow-up, suggesting more maintained reduction in symptoms over time with rESWT in contrast to early onset of relief generally seen within corticosteroid injection. The duration of efficacy following rESWT should be studied in future studies, as 24 weeks is likely not sufficient enough to identify regression in efficacy and potential return of symptoms.

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