Treatment of Peripheral Neuropathic Pain

Oslo University Hospital17 enrolled

Overview

Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. This also applies to new deep rTMS coils which permits stimulation of larger cortical areas and with deeper penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep, psychological fatctors, everyday functioning, and executive functioning.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Neuropathic Pain

Interventions

repetitive Transcranial Magnetic StimulationDEVICE

Deep rTMS is delivered with the Brainsway H7-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head targeting the primary motor cortex of the leg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-80 years of age * Peripheral neuropathic pain related to postherpetic neuralgia, peripheral nerve injury, limb amputation, polyneuropathy or radiculopathy, fulfilling the criteria for probable or definite neuropathic pain (Finnerup et al. 2016) * Usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the BPI at screening * Daily pain * Pain for at least 3 months * Stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to inclusion participation * Ability to follow throughout the whole duration of the study Exclusion Criteria: atients with phantom limb pain after limb amputation * Any clinically significant or unstable medical or psychiatric disorder * Subjects protected by law (guardianship or tutelage measure) * History of or current substance abuse (alcohol, drugs) * Pending litigation * Contraindication to rTMS (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. All women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception) * Pain conditions more severe than peripheral neuropathic pain * Inability to understand the protocol or to fill out the forms * Other ongoing research protocol or recent past protocol within one month before the inclusion

Locations (1)

Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,

Oslo, Norway

Outcomes

Primary Outcomes

Usual pain intensity over the past 24 hours

Measured every day in a diary at the same hour (end of the day) on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)

Time frame: Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values (one week before treatment) and 1 week after the last stimulation. Measurement ends 3 weeks after last stimulation]

Secondary Outcomes

Usual pain intensity over the past 24 hours

Measured every day in a diary at the same hour on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)

Time frame: Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values and 3 weeks after the last stimulation

Pain intensity over the last 24 hours

Maximum and minimum pain intensity hours, rated from 0 (no pain) to 10 (pain as bad as you can imagine)

Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

Pain unpleasantness during the last 24 hours

Maximum, minimum, and usual pain unpleasantness, rated from 0 (no pain/unpleasantness) to 10 (unpleasantness as bad as you can imagine)

Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

Intensity of dynamic mechanical allodynia

Dynamic mechanical allodynia is assessed using a brush (SOMEDIC). The outcome is the mean pain intensity of 3 brush strokes within 2 seconds intervals. The length of the brush stroke is 3 cm, measured on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable), disregarding the spontaneous ongoing pain.

Time frame: Baseline, 1 week and 3 weeks after the end of each stimulation period

Data from ClinicalTrials.gov

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