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Completed

NCT Number: NCT06728215

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

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).

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ars Fisio

Rome, 00189, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..).

Treatment and study plan

CRET 1

Device

Fisiowarm 7.0 and the new capacitive/resistive electrode, for 15' at a frequency of 300 KHz (Treated Group).

CRET 2

Device

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).

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

D&V FARMA srl

Industry

Registry information

Official study title

CRET Therapy in Low Back Pain Treatment.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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