Chronic Pain, Low Back Pain
Conditions
Keywords
Low back pain, chronic pain, tDCS, transcranial direct current stimulation
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.
Interventions
DEVICEsham-tDCS + back school
sham tDCS + back school
DEVICEreal-tDCS + back school
real tDCS + back school
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Visual Analogue Scale (VAS) for pain | 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. | Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain: mild = 1-3, moderate = 4-7, severe = 8-10 For rating Chronic Pain: Excellent internal consistency for a single pair of rating between Numeric Pain Rating Scale and Visual Analogue Scale (r = 0.86) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment (PGA) | 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. | PGA is a scale where the patient gives a score ranging from 1 (serious deterioration) and 7 (big improvement) relative to their pain compared to baseline |
| Roland Morris Disability Questionnaire (RMDQ) | 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. | The Roland-Morris disability questionnaire is composed of 24 yes/no questions designed to assess bac 242) Excellent: RMDQ and the Quebec Back Pain Disability Scale (r= 0.77) SIP and RMDQ Assessment The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain |
| The Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) | 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. | — |
| Clinical Global Impression (CGI) | 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. | CGI is a scale consisting of two items: the severity of the disease (1=normal, 7=very serious) and the overall improvement (1=much improved, 7=much worse). |
| The Patient Health Questionnaire - 9 (PHQ-9) | 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. | PHQ-9 assesses depression symptoms that we tracked as possible confounding factor. |
| VAS for anxiety (0-10) | 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. | VAS for anxiety assesses anxiety symptoms that we tracked as possible confounding factor. |
| Euroquol (Eq-5D) | 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. | — |
Countries
Italy
Outcome results
None listed