Focal Microvibration and Chronic Lumbosacral Radicular Pain

NCT06301061 | Not Yet Recruiting

• 1 other identifier: PB001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Pain, Chronic; Lumbosacral Radiculopathy; Radicular; Neuropathic

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Change in pain intensity with numeric rating scale (NRS): NRS ranges from 0 (no pain) to 10 (the the worst pain imaginable)

  12 months

Secondary Outcomes (2)

• Pain interference in daily life

  12 months

• Disability

  12 months

Study Arms (3)

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.

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.

Device: Sham

Patients treated with standard pharmacological approach

ACTIVE COMPARATOR

Patients will be treated with standard pharmacological therapy

Drug: Gabapentin; Pregabalin; Duloxetine; Amitriptyline

Interventions

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

Patients treated with Focal Microvibration

Sham DEVICE

Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients

Also known as: No active device

Patients treated with a Sham device

Gabapentin; Pregabalin; Duloxetine; Amitriptyline DRUG

Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines.

Also known as: Drugs for neuropathic pain

Patients treated with standard pharmacological approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patients affected by fibromyalgia.
• Patients undergone central nervous system surgery
• Patients with reduced renal function eGFR≤60ml/min/1,73m2

Sponsors & Collaborators

• Federico II University: lead

Related Publications (1)

• 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.

  PMID: 38057548 RESULT

MeSH Terms

Conditions

Chronic Pain; Radiculopathy

Interventions

Gabapentin; Pregabalin; Duloxetine Hydrochloride; Amitriptyline; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share