TranscutaneousNCT06710704
Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis
A study testing Transcutaneous pulsed radiofrequency and Methylprednisolone and mepacaine in people with Transcutaneous and Pulsed Radiofrequency, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transcutaneous, Pulsed Radiofrequency, Corticosteroids Injections
- What is being tested?
- Transcutaneous pulsed radiofrequency and Methylprednisolone and mepacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 24 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18-65 years.
- Both sexes.
- Symptomatic lateral epicondylitis for more than 6 months.
- Lateral epicondylitis was diagnosed when pain is elicited by two or more of these diagnostic exams:
- Palpation of the lateral epicondyle.
- Resisted wrist extension (Thompson test).
- Chair test. With the shoulder flexed to 60° and the elbow extended, the patient attempts to lift a chair weighing 3.5 kg.
Who cannot join
- Severe systemic diseases (diabetes or rheumatoid arthritis).
- Cervical radiculopathy.
- Major trauma or prior surgery in the tendon of the elbow.
- Morbid obese patients (body mass index (BMI) of >35 kg/m2).
- Infection at site of injection.
- Bleeding diathesis and coagulopathy.
- Patients who didn't consent to completing visual analog scale , rated tennis elbow evaluation (PRTEE), disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. and refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis
The aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis
Read the detailed description
Lateral epicondylitis (LE), or tennis elbow, is the most common elbow pain condition. Pain in the lateral aspect of the elbow, especially the extensor tendon origin (extensor carpi radialis brevis [ECRB] and extensor digitorum communis [EDC]), is the most consistent symptom. It affects up to 3 % of the population and is usually an overload injury that often follows minor and often unrecognized trauma to the extensor forearm muscles of the forearm.
Transcutaneous pulsed radiofrequency treatment is a noninvasive, needleless, painless, office/outpatient treatment that requires no recovery, sedation, or anesthesia. We were encouraged to research transcutaneous pulsed radiofrequency as a treatment option because of favorable outcomes in previous trials. Therefore, transcutaneous pulsed radiofrequency treatment used successfully in a type of orthopedic surgeries, we designed this trial to examine it in the management of pain in lateral epicondylitis.
- Conditions
- Transcutaneous, Pulsed Radiofrequency, Corticosteroids Injections, Pain, Lateral Epicondylitis
- Being tested
- Transcutaneous pulsed radiofrequency, Methylprednisolone and mepacaine
- Medical subject headings
- Pain, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous pulsed radiofrequencyDevice
Patients underwent transcutaneous PRF at the affected elbow.
Methylprednisolone and mepacaineDrug
Patients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous pulsed radiofrequency group | Experimental | Patients underwent transcutaneous pulsed radiofrequency at the affected elbow. Receives: Device: Transcutaneous pulsed radiofrequency |
| Control group | Active comparator | Patients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions. Receives: Drug: Methylprednisolone and mepacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain.
Assessment of pain severity by visual analog scale (VAS) before treatment and at 2, 4, 8, and 12 weeks after treatment.
The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain."
Measured: 12 weeks after treatment
Secondary outcomes (3)
Forearm pain
Forearm pain wasassessed by patient-rated tennis elbow evaluation (PRTEE).
The Rated Tennis Elbow Evaluation (PRTEE) was also used to rate the levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale - 5 items (0 = no pain, 10 = worst imaginable). Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items.
Measured: 12 weeks after treatment
Functional disability
Functional disability was assessed by patient-rated tennis elbow evaluation (PRTEE) before treatment and at 2, 4, 8, and 12 weeks after treatment..
The Rated Tennis Elbow Evaluation (PRTEE) was also used to rate the levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale - 5 items (0 = no pain, 10 = worst imaginable). Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items.
Measured: 12 weeks after treatment
Patient capability
Patient capability to operate daily activities was evaluated using Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire before treatment and at 2, 4, 8, and 12 weeks after treatment.
The Quick DASH is a shortened edition of the original DASH result amount. Quick DASH was used to measure of self-rated upper-extremity disability and symptoms before. It is a 11-item and self-report questionnaire that looks at the ability of a patient to perform certain upper extremity activities, patients can rate difficulty and interference with daily life on a 5-point Likert scale (1 being no difficulty, 5 being unable).
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Apr 2024
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TranscutaneousStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Ahmed Elgazzar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710704
- Sponsor's protocol ID
- 36264MS267/7/23
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06710704
- Acronym / sponsor ID
- 36264MS267/7/23
- Conditions
- Transcutaneous, Pulsed Radiofrequency, Corticosteroids Injections, Pain, Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 29 Nov 2024 (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.
The aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis
Detailed description
Lateral epicondylitis (LE), or tennis elbow, is the most common elbow pain condition. Pain in the lateral aspect of the elbow, especially the extensor tendon origin (extensor carpi radialis brevis [ECRB] and extensor digitorum communis [EDC]), is the most consistent symptom. It affects up to 3 % of the population and is usually an overload injury that often follows minor and often unrecognized trauma to the extensor forearm muscles of the forearm.
Transcutaneous pulsed radiofrequency treatment is a noninvasive, needleless, painless, office/outpatient treatment that requires no recovery, sedation, or anesthesia. We were encouraged to research transcutaneous pulsed radiofrequency as a treatment option because of favorable outcomes in previous trials. Therefore, transcutaneous pulsed radiofrequency treatment used successfully in a type of orthopedic surgeries, we designed this trial to examine it in the management of pain in lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous pulsed radiofrequency group | Experimental | Device: Transcutaneous pulsed radiofrequencyPatients underwent transcutaneous pulsed radiofrequency at the affected elbow. |
| Control group | Active comparator | Drug: Methylprednisolone and mepacainePatients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18-65 years.
- Both sexes.
- Symptomatic lateral epicondylitis for more than 6 months.
- Lateral epicondylitis was diagnosed when pain is elicited by two or more of these diagnostic exams:
- Palpation of the lateral epicondyle.
Key exclusion criteria (7 listed)
- Severe systemic diseases (diabetes or rheumatoid arthritis).
- Cervical radiculopathy.
- Major trauma or prior surgery in the tendon of the elbow.
- Morbid obese patients (body mass index (BMI) of >35 kg/m2).
- Infection at site of injection.
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 |
|---|---|---|
| Transcutaneous pulsed radiofrequencyPatients underwent transcutaneous PRF at the affected elbow. | Device | Transcutaneous pulsed radiofrequency group |
| Methylprednisolone and mepacainePatients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions. | Drug | Control group |
Primary outcome
Degree of pain.
Time frame: 12 weeks after treatment
Assessment of pain severity by visual analog scale (VAS) before treatment and at 2, 4, 8, and 12 weeks after treatment. The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain."
3 secondary outcomes
Forearm pain
Time frame: 12 weeks after treatment
Functional disability
Time frame: 12 weeks after treatment
Patient capability
Time frame: 12 weeks after treatment
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 29 Nov 2024.
- Individual participant dataSharing planned: Yes. The data was available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Transcutaneous pulsed radiofrequency and Methylprednisolone and mepacaine in people with Transcutaneous and Pulsed Radiofrequency, run by Tanta University at 1 site in Egypt.
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 7 inclusion and 7 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 29 Nov 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 Egypt. 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?
Degree of pain. (time frame: 12 weeks after treatment). 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 29 Nov 2024.