tDCS Effects on Chronic Low Back Pain

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

sham-tDCS + back school

real-tDCS + back school

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, chronic pain, tDCS, transcranial direct current stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ferrara University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

sham-tDCS + Back School

real-tDCS + Back School

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Clinical Global Impression (CGI)

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)

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)

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)

Euroquol (Eq-5D)

The Patient Health Questionnaire - 9 (PHQ-9)

PHQ-9 assesses depression symptoms that we tracked as possible confounding factor.

VAS for anxiety (0-10)

VAS for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.

Full Information

NCT ID

NCT01875029

First Posted

May 21, 2013

Last Updated

January 15, 2014

Sponsor

University Hospital of Ferrara

1. Study Identification

Unique Protocol Identification Number

NCT01875029

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Ferrara

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Chronic Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sham-tDCS + Back School

Arm Type

Sham Comparator

Arm Description

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.

Arm Title

real-tDCS + Back School

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

sham-tDCS + back school

Intervention Description

sham tDCS + back school

Intervention Type

Device

Intervention Name(s)

real-tDCS + back school

Intervention Description

real tDCS + back school

Primary Outcome Measure Information:

Title

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

Description

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)

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.

Secondary Outcome Measure Information:

Title

Clinical Global Impression (CGI)

Description

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).

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.

Title

Patient Global Assessment (PGA)

Description

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

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.

Title

Roland Morris Disability Questionnaire (RMDQ)

Description

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

Time Frame