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

Istanbul University

Status: Unknown

Conditions: Lumbar Spinal Stenosis

Treatments: Device: active tDCS; Device: sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03958526

LSS tDCS

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Active stimulation over M1

Treatment:

Device: active tDCS

Sham

Placebo Comparator group

Description:

Sham stimulation over M1

Treatment:

Device: sham tDCS