the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease PatientsRCT/TECARNCT07066072
The Radiofrequency Therapy in Management of Sickle Cell Disease Chronic Pain RCT Tested the Effect of TECAR Therapy on Sickle Cell Disease Chronic Pain.
A study testing Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer). and standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed in people with the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients, run by Cairo University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients
- What is being tested?
- Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer). and standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Mar 2025
- 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 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Those patients with associated chronic disease or end organ damage.
- patients in acute Vaso occlusive crisis.
- Patients on antiepileptics or antidepressant drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Radiofrequency Therapy in Management of Sickle Cell Disease Chronic Pain
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 .
Read more
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:
- VAS questionnaire.
- BPI questionnaire.
- HRQOL questionnaire.
Read the detailed description
This randomized non blinded controlled study was conducted as collaboration between Haematology department in Cairo university Children hospital and the Anaesthesia department in Cairo university hospital from the period between 2022\&2024 patients were recruited from Haematology clinic who fulfilled inclusion criteria in absence of exclusion criteria.
Inclusion criteria:
- All types of sickle cell disease (SS/SB0/SB+/SS trait)
- Age of participants ranging from 6 years to 30 years.
- SCA participants with known and unknown cause of chronic pain
Exclusion criteria:
- Those participants with associated chronic disease or end organ damage.
- participants in acute Vaso occlusive crisis.
- Participants on antiepileptics or antidepressant drugs.
Participants and grouping:
This study investigated the effect of Transcutaneous Electrical Capacitive Resistive (TECAR) therapy on chronic pain in 170 Sickle Cell Anemia (SCA) participants.
TECAR session:
These sessions were done for TECAR group participants on a fixed site of pain which was back and lower limbs. The participants were lying in a supine position, and the session is done for around 40 minutes in 2 positions consequently (each site 20 minutes).
Drainage position: The capacitive plates were inserted over the sole of feet while the passive plate was inserted under the back facing lumbar vertebrae for 20 minutes. The temperature was adjusted to 37OC.
The frequency selected was one of three available frequencies (0.8, 1, or 1.2 megahertz) associated with the highest tissue uptake (the frequency associated with the greatest number of light arrows on the right screen of each channel).
Low back position: the capacitive and resistive probes were placed blindly over the most tender areas and temperature was adjusted to 41OC for 20 minutes.
Immediately before and 30 minutes after each session VAS was recorded for pain assessment.
- Being tested
- Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer)., standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed
- Keywords
- radiofrequency, sickle cell disease, chronic pain
- Medical subject headings
- Anemia, Sickle Cell, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer).Device
the Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) will be assigned to TECAR group
standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if neededOther
this is the standard medical care assigned to control group
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | the control group will have no intervention will be on standard of care therapy known for sickle cell disease meaning pharmacological therapy in form of hydroxyurea,analgesics and blood transfusion. Receives: Other: standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed |
| TECAR group | Active comparator | the tecar group will receive 12 sessions of Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) over totally 6 weeks (2 sessions/week) Receives: Device: Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
We categorized the patients studied according to change in the recorded VAS score between before 1st session and 30 minutes after the first session into the following five subgroups:
- st group: VAS turned to 0.
- nd group: VAS turned out to be less than 4.
- rd group: VAS turned to 4.
- th group: VAS turned to above 4.
- th group: VAS remained the same.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Dec 2022
- Primary completion1 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease PatientsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mai mohamed abdelhamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066072
- Sponsor's protocol ID
- REC No: MD-45-2023
- Other IDs
- REC No: MD-45-2023
- Acronym
- RCT/TECAR
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Radiofrequency Therapy in Management of Sickle Cell Disease Chronic Pain
- ClinicalTrials.gov ID
- NCT07066072
- Acronym / sponsor ID
- RCT/TECAR / REC No: MD-45-2023
- Keywords
- radiofrequency, sickle cell disease, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 15 Jul 2025 (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 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:
- VAS questionnaire.
- BPI questionnaire.
- HRQOL questionnaire.
Detailed description
This randomized non blinded controlled study was conducted as collaboration between Haematology department in Cairo university Children hospital and the Anaesthesia department in Cairo university hospital from the period between 2022\&2024 patients were recruited from Haematology clinic who fulfilled inclusion criteria in absence of exclusion criteria.
Inclusion criteria:
- All types of sickle cell disease (SS/SB0/SB+/SS trait)
- Age of participants ranging from 6 years to 30 years.
- SCA participants with known and unknown cause of chronic pain
Exclusion criteria:
- Those participants with associated chronic disease or end organ damage.
- participants in acute Vaso occlusive crisis.
- Participants on antiepileptics or antidepressant drugs.
Participants and grouping:
This study investigated the effect of Transcutaneous Electrical Capacitive Resistive (TECAR) therapy on chronic pain in 170 Sickle Cell Anemia (SCA) participants.
TECAR session:
These sessions were done for TECAR group participants on a fixed site of pain which was back and lower limbs. The participants were lying in a supine position, and the session is done for around 40 minutes in 2 positions consequently (each site 20 minutes).
Drainage position: The capacitive plates were inserted over the sole of feet while the passive plate was inserted under the back facing lumbar vertebrae for 20 minutes. The temperature was adjusted to 37OC.
The frequency selected was one of three available frequencies (0.8, 1, or 1.2 megahertz) associated with the highest tissue uptake (the frequency associated with the greatest number of light arrows on the right screen of each channel).
Low back position: the capacitive and resistive probes were placed blindly over the most tender areas and temperature was adjusted to 41OC for 20 minutes.
Immediately before and 30 minutes after each session VAS was recorded for pain assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if neededthe control group will have no intervention will be on standard of care therapy known for sickle cell disease meaning pharmacological therapy in form of hydroxyurea,analgesics and blood transfusion. |
| TECAR group | Active comparator | Device: Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer).the tecar group will receive 12 sessions of Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) over totally 6 weeks (2 sessions/week) |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Those patients with associated chronic disease or end organ damage.
- patients in acute Vaso occlusive crisis.
- Patients on antiepileptics or antidepressant drugs.
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 |
|---|---|---|
| Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer).the Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) will be assigned to TECAR group | Device | TECAR group |
| standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if neededthis is the standard medical care assigned to control group | Other | control group |
Primary outcome
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.
Time frame: 30 minutes
We categorized the patients studied according to change in the recorded VAS score between before 1st session and 30 minutes after the first session into the following five subgroups: 1. st group: VAS turned to 0. 2. nd group: VAS turned out to be less than 4. 3. rd group: VAS turned to 4. 4. th group: VAS turned to above 4. 5. th group: VAS remained the same.
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 Jul 2025.
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 Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer). and standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed in people with the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients, run by Cairo 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 3 inclusion and 3 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 Jul 2025. 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. 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 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?
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. (time frame: 30 minutes). 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 Jul 2025.