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CompletedNCT07066072RCT/TECARUpdated Jul 15, 2025

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

An interventional study of 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 the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Dec 2022, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
6 Years to 30 Years
Sex
All
01

Study 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.
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:

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

Exclusion criteria:

  1. Those participants with associated chronic disease or end organ damage.
  2. participants in acute Vaso occlusive crisis.
  3. 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.

02

Conditions studied

  • the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients

Keywords

  • radiofrequency
  • sickle cell disease
  • chronic pain
03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 170 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Those patients with associated chronic disease or end organ damage.
  2. patients in acute Vaso occlusive crisis.
  3. Patients on antiepileptics or antidepressant drugs.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Placebo comparator
    control group

    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.

    Other: standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed

  • Active comparator
    TECAR group

    the tecar group will receive 12 sessions of Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) over totally 6 weeks (2 sessions/week)

    Device: Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer).

Interventions

  • DeviceTecar therapy (TECAR: Capacitive and Resistive Energy Transfer).

    the Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) will be assigned to TECAR group

  • Otherstandard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed

    this is the standard medical care assigned to control group

06

What researchers measure

Primary outcomes

  1. 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: 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.

    Time frame: 30 minutes

07

Study locations

1 site
  • Cairo University
    Cairo, Cairo Governorate 12613, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07066072
Lead sponsor
Cairo University
Responsible party
mai mohamed abdelhamed (assisstant lecturer mai mohamed abdelhamed pediatric department principal investigator, Cairo University) — Principal investigator
First posted
Jul 15, 2025
Start date
Dec 1, 2022
Primary completion
Jan 1, 2025
Completion
Mar 30, 2025
Last update
Jul 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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