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

NCT04617197 | Completed

• 1 other identifier: N202009001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Specific Chronic Low Back Pain

Keywords

Transcutaneous electrical nerve stimulation; non specific chronic low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes of Heart rate variability

  Time point = 0 week (before treatment) and 4 week (after a 4-week treatment )

Other Outcomes (1)

• Adverse rate

  Time period during 4-week treatment

Study Arms (3)

Variable-frequency combination 1

EXPERIMENTAL

Non disclosure

Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy

Variable-frequency combination 2

ACTIVE COMPARATOR

Non disclosure

Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy

Control (Placebo)

PLACEBO COMPARATOR

Non-disclosure

Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy

Interventions

Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy DEVICE

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,)

Control (Placebo); Variable-frequency combination 1; Variable-frequency combination 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• Taiwan Resonant Waves Research Corp.: collaborator

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 27418854 RESULT

• 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.

  PMID: 25636503 RESULT

• 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.

  PMID: 30881088 RESULT

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 5, 2020
• Study Start: September 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)