Status:
COMPLETED
tDCS Effects on Chronic Low Back Pain
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Low Back Pain
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Back School (BS) is a behavioural intervention designed to treat and prevent chronic low back pain. Up to date clinical research studies have shown that transcranial direct current stimulation (tDCS) ...
Detailed Description
Chronic low back pain involves high individual and social costs. Back School (BS) is a behavioural intervention designed to treat and prevent the aforementioned condition. Up to date clinical research...
Eligibility Criteria
Inclusion
- males and females aged \> 18 years and \<75 years
- presence of non-specific chronic low back pain diagnosed \> 2 years
- presence of a chronic pain measurable with the VAS scale not less than 3 during a 2 weeks daily VAS monitoring
- pain refractory to drugs (opioid analgesics, tricyclic antidepressants, antiepileptic drugs). It is considered a refractory pain if there is at least 6 months of treatment with at least 2/3 of the above drugs
Exclusion
- spine surgery
- cognitive impairment assessed with Mini Mental Status Examination \<24
- contraindications to tDCS: presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
- Neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- Pregnancy
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01875029
Start Date
January 1 2012
End Date
December 1 2013
Last Update
January 16 2014
Active Locations (1)
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1
Ferrara University Hospital
Ferrara, Italy