Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy

Insertional Achilles Tendinopathy Clinical Trial

Official title:

Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683641
• Other study ID #: MURA2016/427
• Status: Completed
• Phase: N/A
• Start date: July 4, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: September 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed as insertional Achilles tendinopathy

• Have symptom at least 6 months

• Willing to participate

Exclusion Criteria:

• History of peritendinous steroid injections within 4 weeks

• Neurological conditions

• Local skin infection

• Ankle arthritis, traumatic, inflammation or deformity of ankle

• History of ankle surgery

• Contraindication for ESWT : Hemophilia, Coagulopathy

Related Conditions & MeSH terms

• Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

Device:
• Extracorporeal Shock Wave Therapy
Use ESWT on chronic insertional Achilles tendinopathy
• Sham Control group
Use sham ESWT on chronic insertional Achilles tendinopathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	Visual Analog Scale of Pain on Achilles tendon, range 0-10, 0 means no pain and 10 is the most severe pain	Up to 24 weeks
Secondary	Visual Analog Scale - Foot and Ankle Thai version	Range 0-100, 0 is worse, 100 is the best. Having 20 questions. Categorized into Pain, Function and other complaints	Up to 24 weeks
Secondary	The amount of rescue drug use	Tablet/day,if amount of drug use is higher mean it is worse	Up to 24 weeks
Secondary	Complications	Investigator collected complication such as pain during procedure, tendon rupture, or surgical rate and calculated the NNH	Up to 52 weeks