Radiofrequence Microtenotomy for Treatment of Achilles Tendinose

Achilles Pain Clinical Trial

— RFM  

Official title:

Treatment of Achilles Tendinose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274557
• Other study ID #: 2014/1277/REK sør-øst
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2017
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose

Description:

Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT & ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients with pain in Achilles tendon for at least 6 weeks.

• MR / ultrasound confirms diagnosis tendinose.

• Pain in sport and daily activities

Exclusion Criteria:

Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance

Related Conditions & MeSH terms

• Achilles Pain

Intervention

Procedure:
• RFM

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Pain reduction. Change of pain from baseline measured with VAS	6.12 weeks and 6,12 months
Secondary	Function	Change from baseline in functionality measured by (FAOS) FOOT & ANKLE SURVEY	6.12 weeks and 6,12 months