Lumbar RadiculopathyPhase 4NCT02030626
Comparison of the Efficacy of rTMS and tDCS of the Motor Cortex in Patients With Chronic Neuropathic Pain
A Phase 4 study of Lumbar Radiculopathy, run by Hospital Ambroise Paré Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radiculopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2013to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Henri Mondor, APHP
Créteil, 94000
About this study
Official 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
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.
Read the 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.
- Conditions
- Lumbar Radiculopathy
- Being tested
- active or placebo rTMS or active or placebo tDCS
- Keywords
- Neuropathic pain, lumbar radiculopathy, rTMS, tDCS, placebo controlled study
- Medical subject headings
- Radiculopathy, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active or placebo rTMS or active or placebo tDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| active rTMS or active tDCS or placebo | Experimental | Active rTMS (10 Hz) of the motor cortex followed by active tDCS (2 mA) of the motor cortex or conversely Receives: Device: active or placebo rTMS or active or placebo tDCS |
| Sham rTMS followed by tDCS (or conversely) | Placebo comparator | Placebo rTMD followed by placebo tDCS or conversely Receives: Device: active or placebo rTMS or active or placebo tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of rTMS and tDCS on average pain intensity
Average pain intensity numerical scales (0-10)
Measured: 7 days after 3 days of stimulation
Secondary outcomes (10)
Comparison of rTMS and sham stimulation on average pain intensity
numerical scale for pain intensity (0-10)
Measured: 7 days after 3 stimulation days
comparison of tDCS and sham stimulation on average pain intensity
numerical scales for pain intensity (0-10)
Measured: at 7 days after 3 days of stimulation
comparison of rTMS and tDCS on current pain
pain intensity (right now)1 hour after each stimulation
Measured: 1 hour after each stimulation session
comparison of rTMS and tDCS on pain intensity
numerical score (0-10) for pain over the last 24 hours
Measured: 2 days after 3 stimulation days
comparison of rTMS versus tDCS and versus sham on BPI interference
BPI interference scale (0-70)
Measured: 7 days after the end of 3 stimulation days
comparison of rTMS versus tDCS and sham on pain catastrophizing
Pain catastrophizing scale (PCS)
Measured: 7 days after the last day of stimulation (3 days)
comparison of rTMS versus tDCS and sham on anxiety and depression
Hospital anxiety and depression scale
Measured: 7 days after the end of stimulation sessions
comparison of rTMS versus tDCS and sham on neuropathic symptoms
Neuropathic pain symptom inventory
Measured: 7 days after the end of stimulations
comparison of rTMS versus tDCS and sham on thermal testing
thermal testing using thermotest on the upper limbs
Measured: 2 days and 7 days after stimulation days
comparison of safety between rTMS and tDCS and between neurostimulation and sham
any emerging side effects
Measured: immediately after each stimulation, then at 2 days and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Didier BOUHASSIRA, MD PhD, Study director, INSERM U 987Jean Pascal LEFAUCHEUR, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030626
- Sponsor's protocol ID
- rTMS versus tDCS
- Other IDs
- 2010-018309-12
- Status last verified
- Dec 2015
- First submitted
- 7 Jan 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02030626
- Acronym / sponsor ID
- rTMS versus tDCS
- Conditions
- Lumbar Radiculopathy
- Keywords
- Neuropathic pain, lumbar radiculopathy, rTMS, tDCS, placebo controlled study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS or active tDCS or placebo | Experimental | Device: active or placebo rTMS or active or placebo tDCSActive rTMS (10 Hz) of the motor cortex followed by active tDCS (2 mA) of the motor cortex or conversely |
| Sham rTMS followed by tDCS (or conversely) | Placebo comparator | Device: active or placebo rTMS or active or placebo tDCSPlacebo rTMD followed by placebo tDCS or conversely |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active or placebo rTMS or active or placebo tDCS | Device | Sham rTMS followed by tDCS (or conversely), active rTMS or active tDCS or placebo |
Primary outcome
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)
10 secondary outcomes
Comparison of rTMS and sham stimulation on average pain intensity
Time frame: 7 days after 3 stimulation days
comparison of tDCS and sham stimulation on average pain intensity
Time frame: at 7 days after 3 days of stimulation
comparison of rTMS and tDCS on current pain
Time frame: 1 hour after each stimulation session
comparison of rTMS and tDCS on pain intensity
Time frame: 2 days after 3 stimulation days
comparison of rTMS versus tDCS and versus sham on BPI interference
Time frame: 7 days after the end of 3 stimulation days
comparison of rTMS versus tDCS and sham on pain catastrophizing
Time frame: 7 days after the last day of stimulation (3 days)
comparison of rTMS versus tDCS and sham on anxiety and depression
Time frame: 7 days after the end of stimulation sessions
comparison of rTMS versus tDCS and sham on neuropathic symptoms
Time frame: 7 days after the end of stimulations
comparison of rTMS versus tDCS and sham on thermal testing
Time frame: 2 days and 7 days after stimulation days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
Related trials for Lumbar Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier BOUHASSIRA, MD PhD study director
INSERM U 987
Jean Pascal LEFAUCHEUR, MD PhD principal investigator
APHP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Lumbar Radiculopathy, run by Hospital Ambroise Paré Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of rTMS and tDCS on average pain intensity (time frame: 7 days after 3 days of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.