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

February 11, 2025 updated by: D&V FARMA srl

CRET Therapy in Low Back Pain Treatment.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • Ars Fisio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data derived from subject affected by low back pain.

Description

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..).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UNIQ capacitive/resistive electrode
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)
Device: CRET 1
Fisiowarm 7.0 and the new capacitive/resistive electrode, for 15' at a frequency of 300 KHz (Treated Group).
monopolar electrode group
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 2 WEEKS
The Visual Analog Scale (VAS) measures pain intensity on a scale of 1 to 10, where 1 represents "no pain" and 10 represents "worst imaginable pain."
2 WEEKS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROM
Time Frame: 2 WEEKS
The Schober test measures the range of motion (ROM) in the lumbar spine during forward bending, with a normal increase of 4-7 cm indicating good flexibility. An increase of less than 4 cm suggests restricted lumbar mobility, often associated with spinal disorders.
2 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D&V FARMA srl

Collaborators

San Giovanni Addolorata Hospital

Investigators

  • Study Director: Alessio Papaianopol, Doctor, Ti Riabilita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FISIO01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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