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Effectiveness of the Solio Alfa Care Plus Device in Treating Low Back Pain

NCT06053034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-09-25

No results posted yet for this study

Summary

Objectives: This double-blind, randomized, prospective, single-centre study evaluated the effectiveness of radiofrequency therapy by the SOLIO Alfa Cure Plus in the treatment of a non-specific low back pain (LBP) Methods: Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were.

Conditions

  • Low Back Pain

Interventions

DEVICE

Solio alpha cure plus

The SOLIO Alfa Cure Plus is the only home-use device with FDA clearance that uses the proprietary synergy of three energy sources (IR, RF, and LLLT), and this study aims to assess the SOLIO Alfa Cure Plus's efficiency in providing pain relief. This technology is the first noninvasive and patented home RF device. SOLIO Alfa Cure Plus uses continuous RF, the internal controller reduces the RF power while reaching the treatment temperature of 39- 42 Celsius.The SOLIO Alfa Cure Plus Device is a round device equipped with a strap for hand holding, it is to be used while connected to a socket. The device is used by an assistant (usually a family member) on the participant's back for 20 minutes while moving it around in circles on the lower back.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-08-01
Completion
2023-09-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053034 on ClinicalTrials.gov