Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-10-31

Brief Summary

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Transcranial Direct Current Stimulation (tDCS) is a promising non-invasive brain stimulation technique in chronic pain. There is no study investigating the effectiveness of tDCS in radiating chronic lower extremity pain related to lumbar spinal stenosis (LSS). The aim of this study is to investigate the effects of tDCS on pain, walking capacity, functional status and quality of life in patients with chronic pain related to LSS.

32 patients diagnosed with chronic pain related to LSS will be enrolled in this prospective, randomized, double blind, placebo-controlled study according to inclusion/exclusion criteria. Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) with a constant current of 2 miliAmpers for 20 minutes. Patients will be evaluated at baseline, on day 1, 5 and 10 (after the session) and 5 days, 1 month and 3 months after treatment.

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Detailed Description

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Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Active stimulation over M1

Group Type ACTIVE_COMPARATOR

active tDCS

Intervention Type DEVICE

Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) contralateral to the most painful side with a constant current of 2 miliAmpers for 20 minutes.

Sham

Sham stimulation over M1

Group Type PLACEBO_COMPARATOR

sham tDCS

Intervention Type DEVICE

Same protocol (electrode montage,session duration) will be used for sham stimulation. But the device won't be active for full 20 minutes.

Interventions

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active tDCS

Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) contralateral to the most painful side with a constant current of 2 miliAmpers for 20 minutes.

Intervention Type DEVICE

sham tDCS

Same protocol (electrode montage,session duration) will be used for sham stimulation. But the device won't be active for full 20 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Magnetic resonance imaging evidence of narrowing of the central canal, lateral recess, and/or foramen.
* Persistent leg pain for at least 3 months
* An average pain intensity score (during walking) of at least 4 out of 10 on the Visual Analog Scale at screening and randomisation
* Persistent neurogenic claudication for at least 3 months
* stable pharmacological treatment for pain and sleep disorders for at least 1 month before the study and throughout the trial
* If present, coexisting low back pain intensity should be less than leg pain intensity.

Exclusion Criteria

* Patients with other neurological or psychiatric disorders including ongoing major depression (Beck Depression Score\>14)
* Uncontrolled/unstable endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal disease
* Inflammatory diseases, cancer
* Severe hip and/or knee osteoarthritis that affects Treadmill Walking Test
* Absolute/relative contraindications of tDCS (past head trauma resulting with loss of consciousness, epilepsy, past neurosurgical intervention, intracranial hypertension, implanted devices, migraine, chronic-severe headache episodes, a history of side effects with non-invasive brain stimulation techniques, skin diseases, pregnancy)

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No