Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06053034 |
| Other study ID # |
847521SMC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
