Evidence map›Paper›PMID 39838493›Full record

Trial reportJournal of orthopaedic surgery and research2025

Assessing the effectiveness of the SOLIO Alfa Cure Plus device in treating low back pain: a randomized controlled study.

Hadari Yotam, Pesah Galia, Goor-Aryeh Itay, Ungar Lior

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of orthopaedic surgery and research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Hadari YotamInstitute for Pain Medicine, Chaim Sheba Medical Center, Tel Hashomer, Israel. Yotamhh@gmail.com.
Pesah GaliaInstitute for Pain Medicine, Chaim Sheba Medical Center, Tel Hashomer, Israel.
Goor-Aryeh ItayInstitute for Pain Medicine, Chaim Sheba Medical Center, Tel Hashomer, Israel.
Ungar LiorInstitute for Pain Medicine, Chaim Sheba Medical Center, Tel Hashomer, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNonspecific low back pain (LBP) has become a significant worldwide public health problem. It is estimated that 84% of people present it at some point in their lives, in which 23% experience its chronic form, negatively affecting their daily lives. Because pain management tool that doesn't require a firm diagnosis, the development of a device, as SOLIO Alfa Cure Plus, that emanates low level laser therapy, radio frequency and heat with the goal of easing chronic back pain was highly expected.

methodsrandomized, single blinded, controlled trial. MEASURES: Numeric Pain Rating Scale (NPRS), the Oswestry Disability Index (ODI) and the Schober's test. 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.

resultsWe observed a larger pain relief in the SOLIO group (42% vs. 23% p = 0.03), and a higher improvement in flexibility (13%) compared to a worsening in the sham group (6.5%; p = 0.04).

conclusionWe concluded that utilizing the SOLIO Alfa Cure Plus device may dramatically reduce back pain and allow patients to experience an improvement in quality of life as a result.

trial registrationThe clinical trials registration is 8475-21-SMC.

Indexed as

Low Back PainLow-Level Light TherapyPain ManagementAdultAgedFemaleHumansMaleMiddle AgedPain MeasurementSingle-Blind MethodTreatment OutcomeDiagnosisLLLT devicesNonspecific low back painPain visual analog scaleRadiofrequencySOLIO Alfa Cure Plus device

Identifiers

PMID39838493
PMCPMC11748835

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.