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tDCS Effects on Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875029
First Posted: June 11, 2013
Last Update Posted: January 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
  Purpose

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.


Condition Intervention Phase
Low Back Pain Chronic Pain Device: sham-tDCS + back school Device: real-tDCS + back school Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sofia Straudi, MD, University Hospital of Ferrara:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).

  • 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

  • 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

  • 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. ]
  • 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. ]
  • 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.

  • 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.


Enrollment: 45
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: sham-tDCS + Back School

This group will receive sham-tDCS for 5 days before back school beginning. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 30 seconds, with an intensity of 1 milliampere.

The back school session, a behavioural intervention,will be given 10 times for 4 weeks.

Device: sham-tDCS + back school
sham tDCS + back school
Experimental: real-tDCS + Back School

This group will receive continuous stimulation lasting 20 minutes daily, for 5 days before back school beginning. The back school session, a behavioural intervention,will be given 10 times for 4 weeks.

Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 20 minutes, with an intensity of 1 milliampere.

Device: real-tDCS + back school
real tDCS + back school

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875029


Locations
Italy
Ferrara University Hospital
Ferrara, Italy
Sponsors and Collaborators
University Hospital of Ferrara
  More Information

Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01875029     History of Changes
Other Study ID Numbers: Low Back Pain_tDCS
First Submitted: May 21, 2013
First Posted: June 11, 2013
Last Update Posted: January 16, 2014
Last Verified: January 2014

Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:
Low back pain
chronic pain
tDCS
transcranial direct current stimulation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms