Radiofrequence Microtenotomy for Treatment of Achilles Tendinose

NCT ID: NCT03274557

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-02

Study Completion Date

2018-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Achilles Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Radiofrequency microtenotomy

Treatment of Achilles tendinose with radio-frequency microtenotomy

Group Type ACTIVE_COMPARATOR

RFM

Intervention Type PROCEDURE

Phusical therapy

Supervised eccentric training

Group Type ACTIVE_COMPARATOR

RFM

Intervention Type PROCEDURE

Interventions

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RFM

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

References

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Al-Ani Z, Meknas D, Kartus JT, Lyngedal O, Meknas K. Radiofrequency Microtenotomy or Physical Therapy for Achilles Tendinopathy: Results of a Randomized Clinical Trial. Orthop J Sports Med. 2021 Dec 20;9(12):23259671211062555. doi: 10.1177/23259671211062555. eCollection 2021 Dec.

Reference Type DERIVED
PMID: 34988234 (View on PubMed)

Other Identifiers

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2014/1277/REK sør-øst

Identifier Type: -

Identifier Source: org_study_id

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