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Extracorporeal shock waves are effective for non-calcifying supraspinatus tendinopathy
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July 2013
Extracorporeal shock waves are effective for non-calcifying supraspinatus tendinopathy
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: A double-blind, randomized, placebo-controlled trial
BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-86Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
20 patients with non-calcifying supraspinatus tendinopathy (NCST) were randomized to extracorporeal shock wave therapy (ESWT) or to placebo treatment. Physical, roentgenographic, MRI, and blood examinations of the shoulder, conducted at six and at twelve weeks after treatment, showed significantly better results with ESWT treatment in the total Constant and Murley Score (CMS), especially for CMS pain and ROM subscales. ESWT presented no adverse events.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
Storz Medical AG, Tagerwilen, Switzerland
Conflicts:
None disclosed
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
3/4
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?
Supraspinatus tendinopathy is a common and disabling condition occurring in people after middle age. For the last 20 years, extracorporeal shock wave therapy (ESWT) has been widely used to treat enthesopathies, but a limited number of studies demonstrated effectiveness in non-calcifying supraspinatus tendinopathy (NCST). The following trial wanted to investigate the short-term efficacy and safety of low energy ESWT in patients suffering from chronic NCST.
What was the principal research question?
Is ESWT effective and safe in reducing pain and improving range of motion in patients with NCST, compared to a placebo, at 6 and 12 weeks after treatment?
Study Characteristics
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Population:
20 patients with NCST with failed conservative treatment of minimum 4 months (n=20)
Intervention:
ESWT Group: Patients underwent 2 treatment sessions, each having shockwaves at an energy flux density of 0.068 mJ/mm squared, separated by a 7-day interval. Age = 50.7 +/- 8.44 (38-64) years (n=11)
Comparison:
Placebo Group: Same treatment sessions, but the device was disconnected from the shockwave generator. Age = 51.11 +/- 13.26 (36-74) years (n=9)
Outcomes:
Constant and Murley score (CMS), range of motion (ROM), number and severity of adverse events questionnaire, and recorded use of pain medication
Methods:
RCT; Double-Blind
Time:
3 months (6, 12 week follow-up)
What were the important findings?
- At 3 months, the mean relative improvement in total CMS in ESWT group was significantly higher than the placebo (74.5% vs. 15.2%, p = 0.914)
- No adverse events were present, apart from slight pain increase in few patients from the ESWT group.
- ESWT group had significantly higher scores in CMS pain (p=0.039) and CMS ROM (p=0.012) subscales at 3 months.
- The use of pain medication (acetaminophen) in both groups was not significantly different (p=0.16)
What should I remember most?
ESWT therapy is effective in short term treatment of NCST and provides improved results in CMS pain and ROM compared to a placebo. The treatment had no adverse effects.
How will this affect the care of my patients?
Low energy ESWT can reduce the pain of people suffering from non-calcifying supraspinatus tendinopathy and can play an important role in successful treatment. More studies with larger sample sizes are required to study this treatments long term effects.
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