Clinical trial NCT06728215: Capacitive-Resistive Energy Transfer (CRET) for the Treatment of Low Back Pain
Official title: CRET Therapy in Low Back Pain Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: D&V FARMA srl
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data derived from subject affected by low back pain.

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).

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.

Eligibility criteria: 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..).

Primary outcomes:
measure: VAS
timeFrame: 2 WEEKS
Secondary outcomes:
measure: ROM
timeFrame: 2 WEEKS
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ars Fisio
Study officials:
affiliation: Ti Riabilita
name: Alessio Papaianopol, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.