TendinopathyNCT03939247
Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
A study testing Active Tecaretherapy, Inactive Tecaretherapy and CPT in people with Tendinopathy, run by University of Liege at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Active Tecaretherapy, Inactive Tecaretherapy and CPT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Apr 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
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
Read the detailed description
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
- Tendinopathy
- Being tested
- Active Tecaretherapy, Inactive Tecaretherapy, CPT
- Keywords
- elbow, tendinopathy, physiotherapy, exercise, electrotherapy
- Medical subject headings
- Tendinopathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TecaretherapyOther
The "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process
Inactive TecaretherapyOther
Inactive "Tecaretherapy": the device will not provide any current.
CPTOther
Conventional physiotherapy treatment (massage, eccentric exercises, stretching)
| Study group | Role | What they receive |
|---|---|---|
| "Conventional PT treatment (CPT)" | Other | All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching; Receives: Other: CPT |
| "CPT + Tecare" | Experimental | 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 Receives: Other: Active Tecaretherapy; Other: CPT |
| "CPT + Placebo Tecare" | Sham comparator | 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 Receives: Other: Inactive Tecaretherapy; Other: CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the "Patient-Rated Tennis Elbow Evaluation" score
This questionnaire, developped for patients with elbow tendinopathy, consists of one part dealing with pain and a second part dealing with function. Each of the 5 items in part 1 is scored using a NRS, ranging from 0 (no pain) to 10 (worst pain imaginable). Part 2 is subdivided into Specific Activities (6 items) and Usual Activities (4 items). The 10 items of part 2 use a scale of 0 (no difficulty) to 10 (unable to perform an activity) to rate function. The total score is the combined score that rates pain and disability of equal importance. The pain score total (out of 50 points) and the functional subscale (60 points for specific activities, plus 40 points for usual activities to give a function subscale out of 100 points /2 to provide the remaining 50%) provide a total score, ranging from 0 (no pain and no functional impairment) to 100 (worst pain imaginable with a very significant functional deficit).
Measured: up to 6 months
Secondary outcomes (2)
change in pain Intensity
0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain)
Measured: up to 6 months
change in pain Pressure thresholds
Measured by means of an algometer
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start25 Apr 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Too difficult to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Demoulin, University of Liege
- Investigators
- Marc Vanderthommen, Prof, Principal investigator, University of LiegeBénédicte Forthomme, Prof, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939247
- Sponsor's protocol ID
- TECARE
- Status last verified
- Jul 2021
- First submitted
- 1 May 2019
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
- ClinicalTrials.gov ID
- NCT03939247
- Acronym / sponsor ID
- TECARE
- Conditions
- Tendinopathy
- Keywords
- elbow, tendinopathy, physiotherapy, exercise, electrotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too difficult to recruit patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled Trial
| Arm | Type | Receives |
|---|---|---|
| "Conventional PT treatment (CPT)" | Other | Other: CPTAll treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching; |
| "CPT + Tecare" | Experimental | Other: Active Tecaretherapy, Other: CPTAll 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 |
| "CPT + Placebo Tecare" | Sham comparator | Other: Inactive Tecaretherapy, Other: CPTAll 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active TecaretherapyThe "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process | Other | "CPT + Tecare" |
| Inactive TecaretherapyInactive "Tecaretherapy": the device will not provide any current. | Other | "CPT + Placebo Tecare" |
| CPTConventional physiotherapy treatment (massage, eccentric exercises, stretching) | Other | "CPT + Placebo Tecare", "CPT + Tecare", "Conventional PT treatment (CPT)" |
Primary outcome
change in the "Patient-Rated Tennis Elbow Evaluation" score
Time frame: up to 6 months
This questionnaire, developped for patients with elbow tendinopathy, consists of one part dealing with pain and a second part dealing with function. Each of the 5 items in part 1 is scored using a NRS, ranging from 0 (no pain) to 10 (worst pain imaginable). Part 2 is subdivided into Specific Activities (6 items) and Usual Activities (4 items). The 10 items of part 2 use a scale of 0 (no difficulty) to 10 (unable to perform an activity) to rate function. The total score is the combined score that rates pain and disability of equal importance. The pain score total (out of 50 points) and the functional subscale (60 points for specific activities, plus 40 points for usual activities to give a function subscale out of 100 points /2 to provide the remaining 50%) provide a total score, ranging from 0 (no pain and no functional impairment) to 100 (worst pain imaginable with a very significant functional deficit).
2 secondary outcomes
change in pain Intensity
Time frame: up to 6 months
change in pain Pressure thresholds
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Too difficult to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Tendinopathy
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Vanderthommen, Prof principal investigator
University of Liege
Bénédicte Forthomme, Prof principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Tecaretherapy, Inactive Tecaretherapy and CPT in people with Tendinopathy, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too difficult to recruit patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the "Patient-Rated Tennis Elbow Evaluation" score (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.