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
April 12, 2023 updated by: Taipei Medical University
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- Taipei Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Variable-frequency combination 1
Non disclosure
|
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,)
|
|
Active Comparator: Variable-frequency combination 2
Non disclosure
|
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,)
|
|
Placebo Comparator: Control (Placebo)
Non-disclosure
|
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,)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes of non-specific chronic low back pain scaled by numerical rating scale
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 )
|
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
Time Frame: Time point = 0 week (before treatment) and 4 week (after a 4-week treatment )
|
standard deviation of the normal-to-normal QRS interval (SDNN)
|
Time point = 0 week (before treatment) and 4 week (after a 4-week treatment )
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse rate
Time Frame: Time period during 4-week treatment
|
Any adverse event accompany with the treatment will be document
|
Time period during 4-week treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gozani SN. Fixed-site high-frequency transcutaneous electrical nerve stimulation for treatment of chronic low back and lower extremity pain. J Pain Res. 2016 Jun 28;9:469-79. doi: 10.2147/JPR.S111035. eCollection 2016.
- Hazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1.
- Gozani SN, Ferree TC, Moynihan M, Kong X. Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. J Pain Res. 2019 Feb 25;12:743-752. doi: 10.2147/JPR.S196129. eCollection 2019.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
October 28, 2020
First Submitted That Met QC Criteria
November 4, 2020
First Posted (Actual)
November 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202009001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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