NCT06053034

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 10, 2023

Last Update Submit

September 21, 2023

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    The Pain Numerical Rating Scale (NRS) - it is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain

    1 month

Secondary Outcomes (1)

  • Disability score

    1 month

Study Arms (2)

Sham device

SHAM COMPARATOR

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.

Device: Solio alpha cure plus

Solio Alpha Plus

ACTIVE COMPARATOR

The SOLIO Alfa Cure Plus Device for patients with LBP- 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. It should be mentioned this is the first trial in Home-RF using an external

Device: Solio alpha cure plus

Interventions

Solio alpha cure plusDEVICE

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.

Sham deviceSolio Alpha Plus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with LBP lasting 6 weeks and less than 6 months (NRS) of 4 or higher), between 18 to 70 years old that possessed assistance of family members

You may not qualify if:

  • patients with fibromyalgia, pregnancy, pacemaker implant, hyper coagulation, cognitive impairment, psychosis diagnosis, addiction, opiate usage, malignant cancer, and BMI \> 35 or 18.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pain Clinic

Study Record Dates

First Submitted

September 10, 2023

First Posted

September 25, 2023

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

IL(1)