CompletedNot Applicable

The Radiofrequency Therapy in Management of Sickle Cell Disease Chronic Pain RCT Tested the Effect of TECAR Therapy on Sickle Cell Disease Chronic Pain.

Egypt170 participantsStarted 2022-12-01

Plain-language summary

The goal of this clinical trial study is to assess effect of radiofrequency on chronic pain of sickle cell disease pain . All SCA participants who fulfilled inclusion and exclusion criteria were 220; only 170 participant agreed to consent for the study . Participants who seek frequent medical attention were included in the TECAR group without randomization and they were 15 patients, and the rest of the participants (155 patient) were randomized according to the following ratio as 1:1.2 respectively for both arms arm1: the TECAR group arm 2: the control group . The main questions to answer are: primary outcome measure: assess short term effect of TECAR therapy on chronic sickle cell diaease chronic pain by assessment of change in pain scores following 1st TECAR session. secondary outcomes: assess long term effect of TECAR therapy by assessment of change in chronic pain scores along overall period of study (6weeks). TECAR (Capacitive and Resistive Energy Transfer device) used: (C-200 Capenergy Spain) participants: 2 arms : one arm: TECAR group. 2nd arm: control group. one arm: received TECAR therapy in addition to the standard of care for SCA (hydroxyurea, analgesics \[NSAIDs or paracetamol\], and blood transfusion on demand). The second arm received standard of care only. tools used to assess pain: 1. VAS questionnaire. 2. BPI questionnaire. 3. HRQOL questionnaire.

Who can participate

Age range

6 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All types of sickle cell disease (SS/SB0/SB+/SS trait)
. Age of patients ranging from 6 years to 30 years.
. SCA patients with known and unknown cause of chronic pain

Exclusion criteria

. Those patients with associated chronic disease or end organ damage.
. patients in acute Vaso occlusive crisis.
. Patients on antiepileptics or antidepressant drugs.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

primary outcome was defined as successful treatment, indicated by patients exhibiting a VAS score below 4 at 30 minutes following the initial first TECAR therapy session.

Timeframe: 30 minutes

Trial details

NCT IDNCT07066072

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients trials