Capacitive-Resistive Energy Transfer (CRET) for the Treatment of Low Back Pain

D&V FARMA srl

Status: Completed

Conditions: Low Back Pain

Treatments: Device: CRET 1; Device: CRET 2

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06728215

FISIO01

Details and patient eligibility

About

This retrospective observational study compares the effectiveness of two CRET therapies in adults with physical dysfunction. It evaluates whether the UNIQ electrode Fisiowarm 7.0 improves lumbar ROM (Schober test) and reduces pain (VAS scores) more effectively than the classical methodology, with assessments at baseline (T0) and two weeks (T1).

Full description

The goal of this retrospective observational study is to compare the effectiveness of two CRET therapy methodologies in adults (mean age ±SD: 51.23±16.89 for treated, 51.20±14.34 for control; M/F ratio: 42%M, 58%F for treated, 40%M, 60%F for control) experiencing physical dysfunction.

The main questions it aims to answer are:

• Does treatment with the UNIQ electrode Fisiowarm 7.0 improve range of motion (ROM) as measured by the Schober test more effectively than the classical methodology?
• Does treatment with the UNIQ electrode Fisiowarm 7.0 reduce pain levels, as reported through VAS scores, more effectively than the classical methodology?

Participants underwent therapy with either Fisiowarm 7.0 or Activ CT8 INDIBA® as per their group assignment.

Have their ROM measured using the Schober test at baseline (T0) and after two weeks (T1).

Report VAS scores before therapy (T0) and after two weeks (T1) to assess pain levels.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• age 18 years old or older
• reported a visual analogic scale (VAS) for pain equal or greater than 6 cm
• a ROM measured by Schober test
• naïve to CRET therapy
• non-concomitant physiotherapy treatment (e.g. diathermy, laser therapy etc..).

Trial design

52 participants in 2 patient groups

UNIQ capacitive/resistive electrode

Description:

subjects with LBP treated with Fisiowarm 7.0 and the new capacitive/resistive electrode (UNIQ electrode Fisiowarm 7.0, Golden Star Srl, Rome, Italy), for 15' at a frequency of 300 KHz (Treated Group)

Treatment:

Device: CRET 1

monopolar electrode group

Description:

Subject with LBP treated with a classical methodology using the monopolar electrode Activ CT8 INDIBA® at a frequency of 448 KHz in both resistive and capacitive modes, for 10 min each mode with two different electrodes. (Control group).

Treatment:

Device: CRET 2