Non Specific Chronic Low Back PainNCT04617197
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
A study testing Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy in people with Non Specific Chronic Low Back Pain, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Specific Chronic Low Back Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Non Specific Chronic Low Back Pain
- Being tested
- Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy
- Keywords
- Transcutaneous electrical nerve stimulation, non specific chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapyDevice
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,)
| Study group | Role | What they receive |
|---|---|---|
| Variable-frequency combination 1 | Experimental | Non disclosure Receives: Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy |
| Variable-frequency combination 2 | Active comparator | Non disclosure Receives: Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy |
| Control (Placebo) | Placebo comparator | Non-disclosure Receives: Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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
standard deviation of the normal-to-normal QRS interval (SDNN)
Measured: Time point = 0 week (before treatment) and 4 week (after a 4-week treatment )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non Specific Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Resonant Waves Research Corp.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617197
- Sponsor's protocol ID
- N202009001
- Status last verified
- Apr 2023
- First submitted
- 28 Oct 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27418854Hazime 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.
PubMed 25636503Gozani 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.
PubMed 30881088
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04617197
- Acronym / sponsor ID
- N202009001
- Conditions
- Non Specific Chronic Low Back Pain
- Keywords
- Transcutaneous electrical nerve stimulation, non specific chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taiwan Resonant Waves Research Corp.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Variable-frequency combination 1 | Experimental | Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapyNon disclosure |
| Variable-frequency combination 2 | Active comparator | Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapyNon disclosure |
| Control (Placebo) | Placebo comparator | Device: Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapyNon-disclosure |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapyTranscutaneous 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,) | Device | Control (Placebo), Variable-frequency combination 1, Variable-frequency combination 2 |
Primary outcome
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'.
1 secondary outcome
Changes of Heart rate variability
Time frame: Time point = 0 week (before treatment) and 4 week (after a 4-week treatment )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Results publication: PubMed 27418854Gozani 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.
- Results publication: PubMed 25636503Hazime 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.
- Results publication: PubMed 30881088Gozani 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.
- Individual participant dataSharing planned: No
Related trials for Non Specific Chronic Low Back Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Comparison of Abdominal Expansion and Abdominal Drawing-In Training With Manual and Verbal Cueing in Chronic Non-Specific Low Back Pain
Chronic Low Back Pain (Non-specific, Uncomplicated)
Recruiting
Immediate Effects of Manual and Verbal Cueing During Movement Control Training in Chronic Non-Specific Low Back Pain
Chronic Low Back Pain (Non-specific, Uncomplicated)
Not yet recruiting
Relationships Between Muscle Activity, Soft Tissue Changes, and Movement Strategies in Individuals With Chronic Low Back Pain
Non-specific Chronic Low Back Pain
Not yet recruiting
The Effect of Core Stabilization Exercises on Balance in Older Adults With Low Back Pain
Chronic Non-Specific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy in people with Non Specific Chronic Low Back Pain, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.