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Low Back PainNCT06728215

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

An observational study of Low Back Pain, run by D&V FARMA srl at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
What is being tested?
CRET 1 and CRET 2
Type of treatment
Medical device
How many people
52 participants
Where
1 siteItaly
Study dates
1 Oct 2023to 1 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Data derived from subject affected by low back pain.

Who may be able to join

  • 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..).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ars Fisio

    Rome, 00189

Other trials in Italy

About this study

Official title: 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).

Read the 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
Being tested
CRET 1, CRET 2
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRET 1Device

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

  • CRET 2Device

    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).

Study groups in NCT06728215
Study groupRoleWhat they receive
UNIQ capacitive/resistive electrodesubjects 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)
Receives: Device: CRET 1
monopolar electrode groupSubject 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).
Receives: Device: CRET 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS

    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."

    Measured: 2 WEEKS

Secondary outcomes (1)

  1. ROM

    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.

    Measured: 2 WEEKS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start1 Oct 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728215
Sponsor's protocol ID
FISIO01
Status last verified
Feb 2025
First submitted
6 Dec 2024
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.

    PubMed 16777886

  • Kim GW, Won YH, Park SH, Seo JH, Kim DH, Lee HN, Ko MH. Effects of a Newly Developed Therapeutic Deep Heating Device Using High Frequency in Patients with Shoulder Pain and Disability: A Pilot Study. Pain Res Manag. 2019 May 2;2019:8215371. doi: 10.1155/2019/8215371. eCollection 2019.

    PubMed 31191789

  • Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

    PubMed 22231424

  • Dunabeitia I, Arrieta H, Torres-Unda J, Gil J, Santos-Concejero J, Gil SM, Irazusta J, Bidaurrazaga-Letona I. Effects of a capacitive-resistive electric transfer therapy on physiological and biomechanical parameters in recreational runners: A randomized controlled crossover trial. Phys Ther Sport. 2018 Jul;32:227-234. doi: 10.1016/j.ptsp.2018.05.020. Epub 2018 May 26.

    PubMed 29870922

  • Clijsen R, Leoni D, Schneebeli A, Cescon C, Soldini E, Li L, Barbero M. Does the Application of Tecar Therapy Affect Temperature and Perfusion of Skin and Muscle Microcirculation? A Pilot Feasibility Study on Healthy Subjects. J Altern Complement Med. 2020 Feb;26(2):147-153. doi: 10.1089/acm.2019.0165. Epub 2019 Oct 3.

    PubMed 31580698

  • Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.

    PubMed 27081203

  • Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.

    PubMed 28359011

  • Barassi G, Mariani C, Supplizi M, Prosperi L, Di Simone E, Marinucci C, Pellegrino R, Guglielmi V, Younes A, Di Iorio A. Capacitive and Resistive Electric Transfer Therapy: A Comparison of Operating Methods in Non-specific Chronic Low Back Pain. Adv Exp Med Biol. 2022;1375:39-46. doi: 10.1007/5584_2021_692.

    PubMed 35147930

  • Bahns C, Happe L, Thiel C, Kopkow C. Physical therapy for patients with low back pain in Germany: a survey of current practice. BMC Musculoskelet Disord. 2021 Jun 19;22(1):563. doi: 10.1186/s12891-021-04422-2.

    PubMed 34147077

  • Amjad F, Mohseni Bandpei MA, Gilani SA, Arooj A. Reliability of modified-modified Schober's test for the assessment of lumbar range of motion. J Pak Med Assoc. 2022 Sep;72(9):1755-1759. doi: 10.47391/JPMA.4071.

    PubMed 36280970

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by D&V FARMA srl at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS (time frame: 2 WEEKS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06728215, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.

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