Effectiveness of the Solio Alfa Care Plus Device in Treating Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Detailed description: 
      Studies have shown that some generally recommended first-line medications for low back pain
      (LPB) are only slightly more effective than placebo controls in double-blind randomized
      trials [10]. For instance, physical exercise in combination with manual therapy often
      produces short-term results [15], such as the epidural corticosteroid injection that presents
      a complication rate between 0% and 9.65%. At the same time, various energy sources are
      thought to have great potential for both general healing and pain relief [11] [12] and there
      are several available devices that make use of this technology [13].

      Infrared therapy (IR) can reach muscles, nerves and even bones, where it reduces inflammation
      by accessing inner layers of tissues. The use of IR therapy has been shown to accelerate
      wound healing, ease arthritis knee pain, increase endorphin levels, and activate
      neuromodulators [19] without any side effects. According to a recent study, IR therapy is
      beneficial for chronic non-specific LBP sufferers in terms of comfort, function, lumbar range
      of motion, and back extensor endurance [20].

      Radio frequency (RF) therapy shows promise as a healing strategy in a variety of etiologies
      [22]- [24] and it one of the most common energy sources for producing therapeutic heat
      levels. RF energy is delivered to soft tissue as part of the mechanism's biophysical
      therapeutic mode to relieve pain, as well as enhancing collagen formation, vascularization,
      and collagen structure in the tissue [22]- [24]. Another energy source is the tow-level laser
      treatment (LLLT), known to induce analgesia, reduce inflammation, and promote healing in a
      variety of musculoskeletal diseases. This technique is based on the theory that light causes
      biochemical changes in cells like photosynthesis in plants. [26]. LLLT may also be used as an
      adjuvant therapy for pain management in patients with neurologic impairments and neuropathic
      pain [27].

      The techniques are potential tools for controlling pain in a variety of etiologies, but
      additional research appears to be needed to fully develop the therapeutic and mechanistic
      role of these techniques. No device combining all three approaches has ever been objectively
      assessed in a randomized clinical trial for pain management. 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 non-invasive 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.

      These three treatment modalities are hypothesized to affect the physiological issue at many
      levels, causing tissue regeneration and pain relief at the cellular and tissue levels, as
      well as changing sensory nerves and cell molecular makeup [18], [20], [25], [27]. Our goal
      was to determine whether the RF component of the treatment has an effect on back pain relief.
    

Intervention name(s): Solio alpha cure plus
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment