An interventional study of Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy in Non Specific Chronic Low Back Pain, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
Transcutaneous electrical nerve stimulation (TENS) is widely used for chronic pain. Recent studies showed frequency-specific microcurrent (FSM) resonant therapy was safe and effective in patients with non-specific chronic low back pain. However, there was no prospective, double-blinded randomized controlled trial to validate the clinical applicability. The goal of this trial is to verify safety and efficacy of FSM using a TENS device, Dragon Waves Resonant Home Care Electronic Nerve Stimulator-DW1330,(Taiwan Resonant Waves Research Co, Taiwan R.O.C), in 60 patients with non-specific low back pain.
Several studies showed that frequency-specific microcurrent (FSM) resonance therapy delivered by transcutaneous electrical nerve stimulation (TENS) device is safe and effective in patients with non-specific low back pain. The regiment of variable-frequency combination (1-10000 Hz or 1-20000 Hz), continuous use for 36-60 mins per day and 30 to 180 days per session has been proven to be safe. To validate the clinical applicability of FSM by using a TENS device, DW-1330 (Taiwan Resonant Waves Research Co., Taiwan R.O.C.), a prospective, randomized, double-blinded trial is proposed. Investigators are going to recruit 60 patients with non-specific low back pain for at least 3 months. Clinical assessments include Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), EuroQol instrument (EQ-5D), Pressure pain threshold (PPT), and Heart rate variability (HRV). The 60 patients were double-blinded, 1:1:1-randomly-distributed into 3 groups using different variable-frequency combinations: (1) Variable-frequency combination 1 (2) Variable-frequency combination 2 (3) Control(Placebo). During the surveillance period, a total of 2 visits and a telephone follow-up is set at Time point = 0, 2(telephone) and 4 week after recruitment. The primary endpoint is the change of NRS. The secondary endpoint is change of Heart rate variability (HRV). The safety evaluated index is the adverse event rate for all 3 groups.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy
Non disclosure
Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy
Non-disclosure
Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy
Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy using (Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW-1330), Taiwan Resonance Wave Research Co., Taiwan R.O.C,)
Changes of non-specific chronic low back pain scaled by numerical rating scale
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity \[1\]. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time frame: Time point = 0 week (before treatment), 2 week (during the treatment, by a telephone follow-up) and 4 week (after a 4-week treatment )
Changes of Heart rate variability
standard deviation of the normal-to-normal QRS interval (SDNN)
Time frame: Time point = 0 week (before treatment) and 4 week (after a 4-week treatment )
Adverse rate
Any adverse event accompany with the treatment will be document
Time frame: Time period during 4-week treatment
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Taipei Medical University