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

NCT06728215 | Completed

• 1 other identifier: FISIO01
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (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."

  2 WEEKS

Secondary Outcomes (1)

• ROM

  2 WEEKS

Study Arms (2)

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

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

Interventions

CRET 1 DEVICE

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

UNIQ capacitive/resistive electrode

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).

monopolar electrode group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data derived from subject affected by low back pain.

You may qualify if:

• 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..).

Sponsors & Collaborators

• D&V FARMA srl: lead

Study Sites (1)

Ars Fisio

Rome, 00189, Italy

Location

Related Publications (10)

• 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.

  PMID: 16777886 BACKGROUND

• 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.

  PMID: 31191789 BACKGROUND

• 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.

  PMID: 22231424 BACKGROUND

• 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.

  PMID: 29870922 BACKGROUND

• 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.

  PMID: 31580698 BACKGROUND

• 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.

  PMID: 27081203 BACKGROUND

• 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.

  PMID: 28359011 BACKGROUND

• 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.

  PMID: 35147930 BACKGROUND

• 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.

  PMID: 34147077 BACKGROUND

• 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.

  PMID: 36280970 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alessio Papaianopol, Doctor

  Ti Riabilita

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

IT (1)