Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy

• ClinicalTrials.gov Identifier: NCT03683641
• Recruitment Status: Completed
• First Posted: September 25, 2018
• Last Update Posted: September 25, 2018
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Mahidol University

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Insertional Achilles Tendinopathy	Device: Extracorporeal Shock Wave Therapy; Device: Sham Control group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy
• Actual Study Start Date: July 4, 2016
• Actual Primary Completion Date: June 28, 2018
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Shock Wave group; Applying shock wave to patient's Achilles tendon insertion	Device: Extracorporeal Shock Wave Therapy; Use ESWT on chronic insertional Achilles tendinopathy
Sham Comparator: Sham Control group; Applying sham shock wave to patient's Achilles tendon insertion	Device: Sham Control group; Use sham ESWT on chronic insertional Achilles tendinopathy

Outcome Measures

Primary Outcome Measures :

1. Visual Analog Scale [ Time Frame: Up to 24 weeks ]
   Visual Analog Scale of Pain on Achilles tendon, range 0-10, 0 means no pain and 10 is the most severe pain

Secondary Outcome Measures :

1. Visual Analog Scale - Foot and Ankle Thai version [ Time Frame: Up to 24 weeks ]
   Range 0-100, 0 is worse, 100 is the best. Having 20 questions. Categorized into Pain, Function and other complaints
2. The amount of rescue drug use [ Time Frame: Up to 24 weeks ]
   Tablet/day,if amount of drug use is higher mean it is worse
3. Complications [ Time Frame: Up to 52 weeks ]
   Investigator collected complication such as pain during procedure, tendon rupture, or surgical rate and calculated the NNH

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03683641
• Other Study ID Numbers: MURA2016/427
• First Posted: September 25, 2018
• Last Update Posted: September 25, 2018
• Last Verified: September 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahidol University:

Insertional Achilles Tendinopathy; Extracorporeal Shock Wave Therapy; Double-blind Randomized Controlled Trial

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries