tDCS Effects on Chronic Low Back Pain

NCT01875029 | Completed Phase 2 DMC

• 1 other identifier: Low Back Pain_tDCS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Chronic Pain

Keywords

Low back pain; chronic pain; tDCS; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

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

  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)

  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 (7)

• 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.

• 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.

• 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 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.

• 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.

Study Arms (2)

sham-tDCS + Back School

SHAM COMPARATOR

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

real-tDCS + Back School

EXPERIMENTAL

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

Interventions

sham-tDCS + back school DEVICE

sham tDCS + back school

sham-tDCS + Back School

real-tDCS + back school DEVICE

real tDCS + back school

real-tDCS + Back School

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, Italy

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: June 11, 2013
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

IT (1)