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

Not Applicable

Completed

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

• Registration Number: NCT07066072
• Lead Sponsor: Cairo University

Brief 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.

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.

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-30
• Study First Submitted: 2025-04-18
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt