Clinical trial NCT03958526: Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Official title: Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: transcranial direct current stimulation
non-invasive brain stimulation
neuromodulation
chronic pain
neurogenic claudication
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in Pain as measured by Visual Analog Scale
timeFrame: 12 weeks
measure: Walking Duration and Distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Functional Status
timeFrame: 12 weeks
measure: Changes in Quality of Life: Short Form-36
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Istanbul University
name: Enes Efe Is, MD
role: PRINCIPAL_INVESTIGATOR
References: