NCT03274557

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 27, 2019

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 4, 2017

Last Update Submit

February 25, 2019

Conditions

Achilles Pain

Keywords

Achilles, tendinose, tendinopathy, pain

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    Pain reduction. Change of pain from baseline measured with VAS

    6.12 weeks and 6,12 months

Secondary Outcomes (1)

  • Function

    6.12 weeks and 6,12 months

Study Arms (2)

Radiofrequency microtenotomy

ACTIVE COMPARATOR

Treatment of Achilles tendinose with radio-frequency microtenotomy

Procedure: RFM

Phusical therapy

ACTIVE COMPARATOR

Supervised eccentric training

Procedure: RFM

Interventions

RFMPROCEDURE
Phusical therapyRadiofrequency microtenotomy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with pain in Achilles tendon for at least 6 weeks.
  • MR / ultrasound confirms diagnosis tendinose.
  • Pain in sport and daily activities

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34988234DERIVED

MeSH Terms

Conditions

TendinopathyPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 7, 2017

Study Start

January 2, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

February 27, 2019

Record last verified: 2017-09

Locations

NO(1)