Radiofrequence Microtenotomy for Treatment of Achilles Tendinose (RFM)

February 25, 2019 updated by: University Hospital of North Norway

Treatment of Achilles Tendinose

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway, 9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Radiofrequency microtenotomy
Treatment of Achilles tendinose with radio-frequency microtenotomy
Procedure: RFM
ACTIVE_COMPARATOR: Phusical therapy
Supervised eccentric training
Procedure: RFM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: 6.12 weeks and 6,12 months
Pain reduction. Change of pain from baseline measured with VAS
6.12 weeks and 6,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function
Time Frame: 6.12 weeks and 6,12 months
Change from baseline in functionality measured by (FAOS) FOOT & ANKLE SURVEY
6.12 weeks and 6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2017

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 4, 2017

First Posted (ACTUAL)

September 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014/1277/REK sør-øst

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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