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

Cairo University (CU)

Status: Completed

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

Treatments: Device: Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer).; Other: standard pharmacological therapy in sickle cell disease like hydroxyurea,paracetamol,ibubrofen and blood transfusion if needed

Study type: Interventional

Funder types: Other

Identifiers

NCT07066072

REC No: MD-45-2023 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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.

Treatment:

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

TECAR group

Active Comparator group

Description:

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

Treatment:

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