NCT Number: NCT02030626
Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain
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.
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Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Hôpital Ambroise Paré, Boulogne-Billancourt, France
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Comparison of rTMS and tDCS on average pain intensity
Time frame: 7 days after 3 days of stimulation
Average pain intensity numerical scales (0-10)
Secondary outcomes
-
Comparison of rTMS and sham stimulation on average pain intensity
Time frame: 7 days after 3 stimulation days
numerical scale for pain intensity (0-10)
-
comparison of tDCS and sham stimulation on average pain intensity
Time frame: at 7 days after 3 days of stimulation
numerical scales for pain intensity (0-10)
-
comparison of rTMS and tDCS on current pain
Time frame: 1 hour after each stimulation session
pain intensity (right now)1 hour after each stimulation
-
comparison of rTMS and tDCS on pain intensity
Time frame: 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
Time frame: 7 days after the end of 3 stimulation days
BPI interference scale (0-70)
-
comparison of rTMS versus tDCS and sham on pain catastrophizing
Time frame: 7 days after the last day of stimulation (3 days)
Pain catastrophizing scale (PCS)
-
comparison of rTMS versus tDCS and sham on anxiety and depression
Time frame: 7 days after the end of stimulation sessions
Hospital anxiety and depression scale
-
comparison of rTMS versus tDCS and sham on neuropathic symptoms
Time frame: 7 days after the end of stimulations
Neuropathic pain symptom inventory
-
comparison of rTMS versus tDCS and sham on thermal testing
Time frame: 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
Time frame: immediately after each stimulation, then at 2 days and 7 days
any emerging side effects
Sponsors and collaborators
Lead sponsor
Hospital Ambroise Paré Paris
Other
Registry information
Official study title
Comparison of the Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation of the Motor Cortex in Patients With Neuropathic Pain Due to Chronic Radiculopathy
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jan 8, 2014
- Registry last updated
- Dec 9, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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