NCT06728215

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

CRET Therapy in Low Back Pain Treatment.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: D&V FARMA srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	CRET 1	Fisiowarm 7.0 and the new capacitive/resistive electrode, for 15' at a frequency of 300 KHz (Treated Group).
DEVICE	CRET 2	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).

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2024-12-11
• Last updated: 2025-02-12

Locations

1 site across 1 country: Italy