Tennis ElbowNCT06116175
Lateral Epicondylitis Continuous Radiofrequency Microtenotomy
A study testing 60 degree thermal radiofequency of tennis elbow in people with Tennis Elbow, run by Iraqi Board of medical specialties at 1 site in Iraq.
Trial summary
prospective study measuring the outcome of continuous radio frequency 60 degree on lateral epicondylitis not responding to traditional ultrasound guided injection Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- 60 degree thermal radiofequency of tennis elbow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2023to 1 Aug 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic tennis elbow no response to traditional injection ultrasound exam reveal swelling of common extensor tendon
Who cannot join
- complete tear of common extensor tendon implanted pace maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Continuous Radiofrequency 60 Celsius Degree in Management of Chronic Lateral Epicondylitis Prospective Study
prospective study measuring the outcome of continuous radio frequency 60 degree on lateral epicondylitis not responding to traditional ultrasound guided injection
- Conditions
- Tennis Elbow
- Being tested
- 60 degree thermal radiofequency of tennis elbow
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 degree thermal radiofequency of tennis elbowProcedure or surgery
under strict aseptic technique ultrasound guided TRF of lateral epicondylitis advanced for 5 mm active tip canula
| Study group | Role | What they receive |
|---|---|---|
| lateral epicondylitis | Experimental | chronic patients of tennis elbow Receives: Procedure: 60 degree thermal radiofequency of tennis elbow |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in pain score after CRF
decrease in numerical analogue score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iraqi Board of medical specialties
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116175
- Sponsor's protocol ID
- M mahdi pain clinic
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: prospective study measuring the outcome of CRF in tennis elbow
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Radiofrequency 60 Celsius Degree in Management of Chronic Lateral Epicondylitis Prospective Study
- ClinicalTrials.gov ID
- NCT06116175
- Acronym / sponsor ID
- M mahdi pain clinic
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Iraqi Board of medical specialtiesUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 3 Nov 2023 (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.
prospective study measuring the outcome of continuous radio frequency 60 degree on lateral epicondylitis not responding to traditional ultrasound guided injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lateral epicondylitis | Experimental | Procedure: 60 degree thermal radiofequency of tennis elbowchronic patients of tennis elbow |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic tennis elbow no response to traditional injection ultrasound exam reveal swelling of common extensor tendon
Key exclusion criteria (1 listed)
- complete tear of common extensor tendon implanted pace maker
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 |
|---|---|---|
| 60 degree thermal radiofequency of tennis elbowunder strict aseptic technique ultrasound guided TRF of lateral epicondylitis advanced for 5 mm active tip canula | Procedure or surgery | lateral epicondylitis |
Primary outcome
decrease in pain score after CRF
Time frame: 6 months
decrease in numerical analogue score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided. prospective study measuring the outcome of CRF in tennis elbow
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60 degree thermal radiofequency of tennis elbow in people with Tennis Elbow, run by Iraqi Board of medical specialties at 1 site in Iraq.
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 1 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Iraq. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
decrease in pain score after CRF (time frame: 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 15 Oct 2024.