Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy
Condition: Insertional Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      There is still limited number of studies in the literature provides insufficient evidence to
      support the use of ESWT in the treatment of insertional Achilles tendinopathy and the
      contribution of a placebo effect to the shock waves was not assessed by previous study. So
      the investigators conducted a double-blinded randomized-controlled trial at the orthopedic
      out-patient clinic, Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital
      between December 2016 and June 2018. Hypothesized that ESWT might be effective on insertional
      Achilles tendinopathy
    

Detailed description: 
      Participants aged 18-70 years old who were diagnosed as insertional Achilles tendinopathy by
      foot and ankle specialists: had symptoms of pain and swelling at Achilles insertion more than
      6 months; failed other standard conservative treatments for 3 months, i.e., rest, medication,
      activity modification, stretching exercise, and heel lift orthosis; be able to complete
      questionnaires; and willing to participate were enrolled. A computerized block-of-four random
      numbers were generated into 2 groups; ESWT and placebo (sham) group. Investigators concealed
      the treatment allocation by sequential sealed opaque envelops. The sealed opaque envelops
      were opened just before the assigned treatment began. The outcome assessment in this study
      was seven times at pre-intervention, 2nd, 3rd, 4th, 6th, 12th and 24th weeks. The
      participants had to complete questionnaire of VAS and VAS-FA Thai version. The investigators
      used mean and standard deviation for continuous variables, and frequency (%) for categorical
      data. For non-normally distributed variables, median and range was presented. Continuous data
      of both interventions was compared using either unpaired t-test or Mann-Whitney U test based
      on normal distribution. While categorical data was compared using Fisher's exact test.
      Repeated measures with Bonferroni post hoc analysis was applied for each intervention
      according to times of follow-up, and between groups. Bartlett's test for equal variances was
      checked the assumption before using analysis of variance. If the data did not meet the
      assumption, non-parametric Kruskal-Wallis was performed. The investigators used STATA 15.0
      Program, College Station, Texas, USA for all statistical analysis. P-value < 0.05 defined as
      a significant level. Sample size was estimated using STATA 15.0 Program based on alpha error
      0.05, beta error 0.2, mean VAS in controls 5.0, mean VAS in intervention group 3.5, standard
      deviation (SD) of both group 2.3,(13) pre-intervention assessment for 1 time,
      post-intervention assessment for 6 times, correlation between the first and the last VAS
      assessment 0.8. The calculated sample size was 12 per group. With 20% increment for loss of
      follow-up, the final sample size was 15 per group. All of them remained in the randomized
      groups and analyzed as intention-to-treat basis.
    

Intervention name(s): Extracorporeal Shock Wave Therapy; Sham Control group
Intervention type(s): Device; Device
Intervention description(s): Use ESWT on chronic insertional Achilles tendinopathy; Use sham ESWT on chronic insertional Achilles tendinopathy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insertional Achilles Tendinopathy; Extracorporeal Shock Wave Therapy; Double-blind Randomized Controlled Trial