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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:
Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Patients treated with standard pharmacological approach | Active Comparator | Patients will be treated with standard pharmacological therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Parkinson's disease, multiple sclerosis, stroke, spine injuries.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38057548 | Result | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000069583 | Pregabalin |
| D000068736 | Duloxetine Hydrochloride |
| D000639 | Amitriptyline |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Sham | Device | Four devices similar to the active one but not able to deliver the microvibration will be applied to the patients |
|
|
| Gabapentin; Pregabalin; Duloxetine; Amitriptyline | Drug | Patients will be treated with drugs (gabapentinoids, Serotonin-norepinephrine reuptake inhibitor, tricyclic antidepressants, opioids) according to guidelines. |
|
|
| 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. |
| 12 months |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |