Transcutaneous Electrical Nerve Stimulation With Frequency Specific Microcurrent Resonance Therapy for Non Specific Chronic Low Back Pain Patents: a Prospective Double Blinded, Randomized, Placebo Control Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcutaneous Electrical Nerve Stimulation With Frequency Specific Microcurrent Resonance Therapy for Non Specific Chronic Low Back Pain Patents: a Prospective Double Blinded, Randomized, Placebo Control Trial

Conditions
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Non Specific Chronic Low Back Pain

Intervention / Treatment
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* Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 years old, male or female. Cases with normal psychological and communication functions who can cooperate with our study. Cases who are willing to sign permits and cooperate with our study including follow up and examination. Cases with complete clinical data and willing to accept investigation. Exclusion Criteria: Cases who diagnose pregnancy within 12 months before included. Cases who diagnose with malignant disease. Cases with a history of epilepsy. Cases who diagnose with fracture without fixation. Cases who diagnose with impaired sensation or psychological function. Cases whose skin condition is not feasible to accept treatment. Cases with pacemaker. Cases who allergic to the conductive medium Cases with a major psychiatric disorder such as schizophrenia or bipolar disorder. Cases with severe visual or auditory disorder. Cases who cannot communicate with the Mandarin language. Other mental diseases are not suitable assessed by the PI

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Variable-frequency combination 1<br>Non disclosure | Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy<br>* 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,)<br>|
| Active Comparator: Variable-frequency combination 2<br>Non disclosure | Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy<br>* 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,)<br>|
| Placebo Comparator: Control (Placebo)<br>Non-disclosure | Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy<br>* 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,)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 point = 0 week (before treatment), 2 week (during the treatment, by a telephone follow-up) and 4 week (after a 4-week treatment ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Heart rate variability | standard deviation of the normal-to-normal QRS interval (SDNN) | Time point = 0 week (before treatment) and 4 week (after a 4-week treatment ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous electrical nerve stimulation, non specific chronic low back pain