Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy

NCT03683641 | Completed DMC

• 1 other identifier: MURA2016/427
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Insertional Achilles Tendinopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analog Scale - Foot and Ankle Thai version

  Up to 24 weeks

• The amount of rescue drug use

  Up to 24 weeks

• Complications

  Up to 52 weeks

Study Arms (2)

Shock Wave group

ACTIVE COMPARATOR

Applying shock wave to patient's Achilles tendon insertion

Device: Extracorporeal Shock Wave Therapy

Sham Control group

SHAM COMPARATOR

Applying sham shock wave to patient's Achilles tendon insertion

Device: Sham Control group

Interventions

Extracorporeal Shock Wave Therapy DEVICE

Use ESWT on chronic insertional Achilles tendinopathy

Shock Wave group

Sham Control group DEVICE

Use sham ESWT on chronic insertional Achilles tendinopathy

Sham Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as insertional Achilles tendinopathy
• Have symptom at least 6 months
• Willing to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 25, 2018
• Study Start: July 4, 2016
• Primary Completion: June 28, 2018
• Study Completion: July 31, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09