The Radiofrequency Therapy in Management of Sickle Cell Disease Chronic Pain RCT Tested the Effect of TECAR Therapy on Sickle Cell Disease Chronic Pain.
NCT07066072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-07-15
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.
Conditions
- the Use of Radiofrequency Ablation in Form of TECAR(Capacitive and Resistive Transfer Energy) in Chronic Pain of Sickle Cell Disease Patients
Interventions
- DEVICE
-
Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer).
the Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer) will be assigned to TECAR group
- OTHER
-
standard 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
Sponsors & Collaborators
-
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-01
- Primary Completion
- 2025-01-01
- Completion
- 2025-03-30
Countries
- Egypt
Study Locations
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