Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy

NCT ID: NCT03939247

Last Updated: 2021-07-13

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

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2021-07-01

Brief Summary

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This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.

60 patients will be randomized into one of the following 3 groups:

* "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises, stretching);
* "CPT + Tecare" (idem CPT group + tecaretherapy during the eccentric exercises)
* "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive Tecare device) The treatment will include 18 30-minute sessions

Detailed Description

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This RCT aims at investigating the effectiveness of the "Tecaretherapy" in patients with lateral elbow tendinopathy.

60 patients will be randomized into one of the following 3 groups:

* "Conventional physiotherapy treatment (CPT)" (massage, eccentric exercises by means of an isokinetic dynamometer, stretching);
* "CPT + Tecare" (idem CPT group + Tecaretherapy during the eccentric exercises)
* "CPT + Placebo Tecare" (idem "CPT + Tecare" group but with an inactive "Tecare" device) The treatment will include 18 30-minute sessions.

The "Tecaretherapy" consists in using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process.

Outcome sessions will be organized at baseline, after the first 9 sessions, at the end of the treatment as well as 3 and 6 months after the initial treatment session.

Conditions

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Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients receiving the "Placebo Tecare" will be blinded by using an identical device as in the active group but which cannot provide any current

Study Groups

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"Conventional PT treatment (CPT)"

All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching;

Group Type OTHER

CPT

Intervention Type OTHER

Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

"CPT + Tecare"

All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching (idem CPT group). However, an active Tecaretherapy is also provided during the sessions

Group Type EXPERIMENTAL

Active Tecaretherapy

Intervention Type OTHER

The "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process

CPT

Intervention Type OTHER

Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

"CPT + Placebo Tecare"

All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching (idem CPT group). However, an inactive Tecaretherapy is also provided during the sessions

Group Type SHAM_COMPARATOR

Inactive Tecaretherapy

Intervention Type OTHER

Inactive "Tecaretherapy": the device will not provide any current.

CPT

Intervention Type OTHER

Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

Interventions

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Active Tecaretherapy

The "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process

Intervention Type OTHER

Inactive Tecaretherapy

Inactive "Tecaretherapy": the device will not provide any current.

Intervention Type OTHER

CPT

Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography

Exclusion Criteria

Patients:

* with contra-indications for a Tecaretherapy (Pace maker, insuline pump, pregnancy, infection, fever, cancer, thrombophlebitis)
* reporting injections and/or shockwaves in the past (for the tendinopathy)
* with an associated neurogenic dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Christophe Demoulin

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Vanderthommen, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Bénédicte Forthomme, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Locations

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CHU Liege

Liège, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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TECARE

Identifier Type: -

Identifier Source: org_study_id

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