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Completed

NCT Number: NCT01875029

tDCS Effects on Chronic Low Back Pain

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ferrara University Hospital

Ferrara, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sham-tDCS + back school

Device

sham tDCS + back school

real-tDCS + back school

Device

real tDCS + back school

Primary outcomes

  1. Change from baseline in Visual Analogue Scale (VAS) for pain

    Time frame: 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 outcomes

  1. Clinical Global Impression (CGI)

    Time frame: 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).

  2. Patient Global Assessment (PGA)

    Time frame: 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

  3. Roland Morris Disability Questionnaire (RMDQ)

    Time frame: 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

  4. The Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)

    Time frame: 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.

  5. Euroquol (Eq-5D)

    Time frame: 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.

  6. The Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 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.

  7. VAS for anxiety (0-10)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

The Effects of Transcranial Direct Current Stimulation (tDCS)Combined With Back School in Subjects With Chronic Low Back Pain. Randomised Control Trial Study.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Jan 16, 2014

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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