Lumbar Radiculopathy
Conditions
Keywords
Neuropathic pain, lumbar radiculopathy, rTMS, tDCS, placebo controlled study
Brief summary
The present study aims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.
Detailed description
The present study ims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation (rTMS) and transcranial direct electrical current (tDCS) of the motor cortex in patients with chronic lumbar radiculopathy on average pain intensity. This will be a sham controlled crossover design : patients will be randomized to receive either active rTMS or tDCS during 3 consecutive days followed by the alternative treatment within 3 weeks apart, or sham rTMS or tDCS during 3 consecutive dats followed by the alternative treatment within 3 weeks apart. The investigator will be blind to the treatment. Assessments will be performed before each treatment, then 1 hour after the end of the third day session, then 2 days and 1 week after the stimulation. Assessments will include pain questionnaires, quality of life, anxiety and depression, catastrophizing and evaluation of treatment effect on experimental pain using Quantitative sensory testing.
Interventions
DEVICEactive or placebo rTMS or active or placebo tDCS
Sponsors
Hospital Ambroise Paré Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Patients aged more than 18 years and less than 60 years, males of females Lumbosciatica or lumbocruralgia with predominant neuropathic components with DN4 score ≥ 4/10 Chronic pain with an intensity of at least 4/10 Stable analgesic treatment for at least 15 days before inclusion Able to speak and understand French Social security
Exclusion criteria
Work accident or litigation Contraindication to rTMS (sismotherapy in the preceding month, epilepsia, past head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy or lactation Major depressive episode Intermittent pain Consent refusal Impossible to follow up during the duration of the study Pain more severe than neuropathic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of rTMS and tDCS on average pain intensity | 7 days after 3 days of stimulation | Average pain intensity numerical scales (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of tDCS and sham stimulation on average pain intensity | at 7 days after 3 days of stimulation | numerical scales for pain intensity (0-10) |
| comparison of rTMS and tDCS on current pain | 1 hour after each stimulation session | pain intensity (right now)1 hour after each stimulation |
| comparison of rTMS and tDCS on pain intensity | 2 days after 3 stimulation days | numerical score (0-10) for pain over the last 24 hours |
| comparison of rTMS versus tDCS and versus sham on BPI interference | 7 days after the end of 3 stimulation days | BPI interference scale (0-70) |
| Comparison of rTMS and sham stimulation on average pain intensity | 7 days after 3 stimulation days | numerical scale for pain intensity (0-10) |
| comparison of rTMS versus tDCS and sham on anxiety and depression | 7 days after the end of stimulation sessions | Hospital anxiety and depression scale |
| comparison of rTMS versus tDCS and sham on neuropathic symptoms | 7 days after the end of stimulations | Neuropathic pain symptom inventory |
| comparison of rTMS versus tDCS and sham on thermal testing | 2 days and 7 days after stimulation days | thermal testing using thermotest on the upper limbs |
| comparison of safety between rTMS and tDCS and between neurostimulation and sham | immediately after each stimulation, then at 2 days and 7 days | any emerging side effects |
| comparison of rTMS versus tDCS and sham on pain catastrophizing | 7 days after the last day of stimulation (3 days) | Pain catastrophizing scale (PCS) |
Countries
France
Outcome results
None listed