Clinical trial NCT01875029: tDCS Effects on Chronic Low Back Pain
Official title: The Effects of Transcranial Direct Current Stimulation (tDCS)Combined With Back School in Subjects With Chronic Low Back Pain. Randomised Control Trial Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Chronic Pain
Keywords: Low back pain
chronic pain
tDCS
transcranial direct current stimulation
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain and facilitating the mechanisms inhibitors descendants of pain control.

The aim of this study is to test the feasibility of combining tDCS with a behavioural intervention (i.e. BS) in subjects with chronic low back pain.

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 studies have shown that transcranial direct current stimulation (tDCS) can be considered a reliable tool for chronic pain. It has been shown how tDCS is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain, such as the thalamus, and facilitating the mechanisms inhibitors descendants of pain control. The aim of this study is to test the feasibility of combining tDCS with a behavioural intervention (i.e. BS) in subjects with chronic low back pain. Specifically, we will test their effects on low back pain intensity and participation of patients' in daily activities.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change from baseline in Visual Analogue Scale (VAS) for pain
timeFrame: 1)one day pre-tDCS treatment. 2) Every day, for 5 days pre and post 20 minutes of tDCS stimulation. 3)One day post tDCS treatment. 4)One day post 10 session of back school. 5)Follow up at one month from the back school end.
Secondary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: 1)One day post tDCS treatment. 2) One day post 10 session of back school. 3) Follow up at one month from the back school end.
measure: Patient Global Assessment (PGA)
timeFrame: 1) One day post tDCS treatment. 2) One day post 10 session of back school. 3) Follow up at one month from the back school end.
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 1)One day pre-tDCS treatment. 2) One day post tDCS treatment. 3) One day post 10 session of back school. 4) Follow up at one month from the back school end.
measure: The Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)
timeFrame: 1)One day pre-tDCS treatment. 2) One day post tDCS treatment. 3) One day post 10 session of back school. 4) Follow up at one month from the back school end.
measure: Euroquol (Eq-5D)
timeFrame: 1)One day pre-tDCS treatment. 2) One day post tDCS treatment. 3) One day post 10 session of back school. 4) Follow up at one month from the back school end.
measure: The Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 1)One day pre-tDCS treatment. 2) One day post tDCS treatment. 3) One day post 10 session of back school. 4) Follow up at one month from the back school end.
measure: VAS for anxiety (0-10)
timeFrame: 1)One day pre-tDCS treatment. 2) One day post tDCS treatment. 3) One day post 10 session of back school. 4) Follow up at one month from the back school end.
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
References: