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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jiunn-Horng Kang, Ph.D, MD
  • Phone Number: +886970405337
  • Email: jhk@tmu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age between 20-80 years old, male or female.
  2. Cases with normal psychological and communication functions who can cooperate with our study.
  3. Cases who are willing to sign permits and cooperate with our study including follow up and examination.
  4. Cases with complete clinical data and willing to accept investigation.

Exclusion Criteria:

  1. Cases who diagnose pregnancy within 12 months before included.
  2. Cases who diagnose with malignant disease.
  3. Cases with a history of epilepsy.
  4. Cases who diagnose with fracture without fixation.
  5. Cases who diagnose with impaired sensation or psychological function.
  6. Cases whose skin condition is not feasible to accept treatment.
  7. Cases with pacemaker.
  8. Cases who allergic to the conductive medium
  9. Cases with a major psychiatric disorder such as schizophrenia or bipolar disorder.
  10. Cases with severe visual or auditory disorder.
  11. Cases who cannot communicate with the Mandarin language.
  12. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Variable-frequency combination 1
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,)
Active Comparator: Variable-frequency combination 2
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,)
Placebo Comparator: Control (Placebo)
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,)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taiwan Resonant Waves Research Corp.

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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