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Low Back PainPhase 2NCT01875029

tDCS Effects on Chronic Low Back Pain

A Phase 2 study testing real-tDCS + back school in people with Low Back Pain and Chronic Pain, run by University Hospital of Ferrara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Low Back Pain, Chronic Pain
What is being tested?
real-tDCS + back school
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteItaly
Study dates
Jan 2012to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ferrara University Hospital

    Ferrara

Other trials in Italy

About this study

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.

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.

Read the 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.

Being tested
sham-tDCS + back school, real-tDCS + back school
Keywords
Low back pain, chronic pain, tDCS, transcranial direct current stimulation
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sham-tDCS + back schoolDevice

    sham tDCS + back school

  • real-tDCS + back schoolDevice

    real tDCS + back school

Study groups in NCT01875029
Study groupRoleWhat they receive
sham-tDCS + Back SchoolSham comparatorThis 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.
Receives: Device: sham-tDCS + back school
real-tDCS + Back SchoolExperimentalThis 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.
Receives: Device: real-tDCS + back school

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

  1. 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).

    Measured: 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.

  2. 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

    Measured: 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.

  3. 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

    Measured: 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.

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

    Measured: 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)

    Measured: 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)

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

    Measured: 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.

  7. VAS for anxiety (0-10)

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01875029
Sponsor's protocol ID
Low Back Pain_tDCS
Status last verified
Jan 2014
First submitted
21 May 2013
Last updated
16 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing real-tDCS + back school in people with Low Back Pain and Chronic Pain, run by University Hospital of Ferrara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01875029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2014.

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tDCS Effects on Chronic Low Back Pain (NCT01875029) | AzTrials