Pain, ChronicNCT06301061
Focal Microvibration and Chronic Lumbosacral Radicular Pain
A study testing Equistasi® and Gabapentin; Pregabalin; Duloxetine; Amitriptyline in people with Pain, Chronic and Lumbosacral Radiculopathy, run by Federico II University.
Trial summary
The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question[s] it aims to answer are: Can focal microvibration improve pain in this patient population? Can focal microvibration improve quality of life in these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Lumbosacral Radiculopathy, Radicular; Neuropathic
- What is being tested?
- Equistasi® and Gabapentin; Pregabalin; Duloxetine; Amitriptyline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain duration≥6 months
- Magnetic resonance imaging (MRI) showing compression of lumbosacral nerve roots
- Neuropathic symptoms in the innervation territory of the compressed spinal nerve roots
- Monolateral pain
- Pain intensity: moderate-severe i.e. numeric rating scale (NRS)≥4.
Who cannot join
- Psychiatric patients
- Cancer patients
- Patients affected by disease characterized by spasticity or muscular stiffness:
- Parkinson's disease, multiple sclerosis, stroke, spine injuries.
- Patients with spinal or dorsal root ganglion stimulators
- Patients undergone central of peripheral stimulation in the past 3 months
Show all 9Show fewer
- Patients affected by fibromyalgia.
- Patients undergone central nervous system surgery
- Patients with reduced renal function eGFR≤60ml/min/1,73m2
About this study
Official title: Effectiveness of Focal Microvibration in the Management of Chronic Lumbosacral Radicular Pain: a Randomized Controlled Study
The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question[s] it aims to answer are:
- Can focal microvibration improve pain in this patient population?
- Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.
Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy.
Read the detailed description
This is the first randomized controlled study aiming to assess the potential use of focal microvibration for the management of chronic lumbosacral radicular pain which is the pain consequent to the compression of a spinal nerve root. Focal microvibration has been so far used to treat gait disorders and instability consequent to diseases such as Parkinson's disease, stroke, ataxia, multiple sclerosis with impressive results and no reported side effects. Our trial involves three arms: one arm treated with a device able to deliver focal microvibration, one arm treated with a sham device, and one arm treated with standard pharmacological therapy according to international guidelines. Patients with the active and with sham devices will attach them on their skin for 6 hours/day except on Thursday and Sunday: this application schedule with two days of treatment suspension has intended to avoid habituation to the sub-perception microvibration stimulation. The follow up will be 12 months and periodic visits will be performed after 7, 15 30, 45, 60, 90, 180, and 360 days of treatment. All the patients enrolled in the study will have access to rescue analgesic drugs such as paracetamol 1g and tramadol 100mg in case on excessive pain. Randomization will be performed by a computer-generated sequence. During the follow up visits, patients will be asked to fill questionnaires to explore and monitor pain intensity and pain interference in daily life: brief pain inventory (BPI) and Oswestry disability index (ODI)
- Being tested
- Equistasi®, Sham, Gabapentin; Pregabalin; Duloxetine; Amitriptyline
- Medical subject headings
- Chronic Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equistasi®Device
Four devices will be attached to the skin according the indication of the investigators for 6 hours/day every day except Thursday and Sunday
ShamDevice
Also called No active device
Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients
Gabapentin; Pregabalin; Duloxetine; AmitriptylineDrug
Also called Drugs for neuropathic pain
Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Focal Microvibration | Experimental | Patients will be treated with focal microvibration through the application on the skin of four devices for 6 hours/day every day except thursady and Sunday. Receives: Device: Equistasi® |
| Patients treated with a Sham device | Sham comparator | Patients will be treated with four sham device which will be attached on the skin for 6 hours/day every day except thursady and Sunday. Receives: Device: Sham |
| Patients treated with standard pharmacological approach | Active comparator | Patients will be treated with standard pharmacological therapy Receives: Drug: Gabapentin; Pregabalin; Duloxetine; Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change in pain intensity with numeric rating scale (NRS): NRS ranges from 0 (no pain) to 10 (the the worst pain imaginable)
Measured: 12 months
Secondary outcomes (2)
Pain interference in daily life
Pain interference in patient daily life: mood, general activity, social relationship, work ability measured by Brief Pain Inventory (BPI). BPI is a 9 item self-administered questionnaire and every item score ranges from 0 to 10: a higher score indicates a worst outcome.
Measured: 12 months
Disability
Disability related to pain severity measured by and Oswestry Disability Index (ODI). ODI score ranges from 0 to 100; a higher score on the ODI indicates a more severe disability caused by low back pain.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Vargas, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301061
- Sponsor's protocol ID
- PB001
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buonanno P, Iacovazzo C, Marra A, de Siena AU, Josu T, Zampi M, Sedda D, Servillo G, Vargas M. Potential Role of Focal Microvibration (Equistasi(R)) in the Management of Chronic Pain: A Pilot Study. Pain Ther. 2024 Feb;13(1):185-198. doi: 10.1007/s40122-023-00562-6. Epub 2023 Dec 6.
PubMed 38057548
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Focal Microvibration in the Management of Chronic Lumbosacral Radicular Pain: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06301061
- Acronym / sponsor ID
- PB001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 8 Mar 2024 (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.
The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question[s] it aims to answer are:
- Can focal microvibration improve pain in this patient population?
- Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.
Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy.
Detailed description
This is the first randomized controlled study aiming to assess the potential use of focal microvibration for the management of chronic lumbosacral radicular pain which is the pain consequent to the compression of a spinal nerve root. Focal microvibration has been so far used to treat gait disorders and instability consequent to diseases such as Parkinson's disease, stroke, ataxia, multiple sclerosis with impressive results and no reported side effects. Our trial involves three arms: one arm treated with a device able to deliver focal microvibration, one arm treated with a sham device, and one arm treated with standard pharmacological therapy according to international guidelines. Patients with the active and with sham devices will attach them on their skin for 6 hours/day except on Thursday and Sunday: this application schedule with two days of treatment suspension has intended to avoid habituation to the sub-perception microvibration stimulation. The follow up will be 12 months and periodic visits will be performed after 7, 15 30, 45, 60, 90, 180, and 360 days of treatment. All the patients enrolled in the study will have access to rescue analgesic drugs such as paracetamol 1g and tramadol 100mg in case on excessive pain. Randomization will be performed by a computer-generated sequence. During the follow up visits, patients will be asked to fill questionnaires to explore and monitor pain intensity and pain interference in daily life: brief pain inventory (BPI) and Oswestry disability index (ODI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Focal Microvibration | Experimental | Device: Equistasi®Patients will be treated with focal microvibration through the application on the skin of four devices for 6 hours/day every day except thursady and Sunday. |
| Patients treated with a Sham device | Sham comparator | Device: ShamPatients will be treated with four sham device which will be attached on the skin for 6 hours/day every day except thursady and Sunday. |
| Patients treated with standard pharmacological approach | Active comparator | Drug: Gabapentin; Pregabalin; Duloxetine; AmitriptylinePatients will be treated with standard pharmacological therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain duration≥6 months
- Magnetic resonance imaging (MRI) showing compression of lumbosacral nerve roots
- Neuropathic symptoms in the innervation territory of the compressed spinal nerve roots
- Monolateral pain
- Pain intensity: moderate-severe i.e. numeric rating scale (NRS)≥4.
Key exclusion criteria (9 listed)
- Psychiatric patients
- Cancer patients
- Patients affected by disease characterized by spasticity or muscular stiffness:
- Parkinson's disease, multiple sclerosis, stroke, spine injuries.
- Patients with spinal or dorsal root ganglion stimulators
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 |
|---|---|---|
| Equistasi®Four devices will be attached to the skin according the indication of the investigators for 6 hours/day every day except Thursday and Sunday | Device | Patients treated with Focal Microvibration |
| ShamAlso: No active deviceFour devices similar to the active one but not able to deliver the microvibration will be applied to the patients | Device | Patients treated with a Sham device |
| Gabapentin; Pregabalin; Duloxetine; AmitriptylineAlso: Drugs for neuropathic painPatients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines. | Drug | Patients treated with standard pharmacological approach |
Primary outcome
Pain intensity
Time frame: 12 months
Change in pain intensity with numeric rating scale (NRS): NRS ranges from 0 (no pain) to 10 (the the worst pain imaginable)
2 secondary outcomes
Pain interference in daily life
Time frame: 12 months
Disability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 38057548Buonanno P, Iacovazzo C, Marra A, de Siena AU, Josu T, Zampi M, Sedda D, Servillo G, Vargas M. Potential Role of Focal Microvibration (Equistasi(R)) in the Management of Chronic Pain: A Pilot Study. Pain Ther. 2024 Feb;13(1):185-198. doi: 10.1007/s40122-023-00562-6. Epub 2023 Dec 6.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Equistasi® and Gabapentin; Pregabalin; Duloxetine; Amitriptyline in people with Pain, Chronic and Lumbosacral Radiculopathy, run by Federico II University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pain intensity (time frame: 12 months). 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 NCT06301061, which also lists 1 linked publication.
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 8 Mar 2024.