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

NCT03958526 | Unknown

• 1 other identifier: LSS tDCS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

transcranial direct current stimulation; non-invasive brain stimulation; neuromodulation; chronic pain; neurogenic claudication

Outcome Measures

Primary Outcomes (2)

• Changes in Pain as measured by Visual Analog Scale

  The visual analog scale for pain is a straight line, 10 centimeters (10 cm) in length with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. A higher score indicates greater pain intensity (0 (min)-10 (max)) .

  12 weeks

• Walking Duration and Distance

  Patients will be asked to walk on a treadmill at zero angle and a self-selected speed until they have to stop due to symptoms of LSS or until a time limit of 30 minutes has been reached. To start the test, the investigator slowly increases the speed to 1.9 km per hour. The subjects will be then allowed to modify the speed during the test to maintain a pace that is comfortable for them. Subjects will be asked to notify the investigator when they first experience a change in symptoms. Subjects will be also asked to avoid holding the handle bars. Total distance and time, distance and time to onset of symptoms will be measured.

  12 weeks

Secondary Outcomes (2)

• Changes in Functional Status

  12 weeks

• Changes in Quality of Life: Short Form-36

  12 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Active stimulation over M1

Device: active tDCS

Sham

PLACEBO COMPARATOR

Sham stimulation over M1

Device: sham tDCS

Interventions

active tDCS 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.

Active

sham tDCS DEVICE

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

Sham

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Is EE, Aksu S, Karamursel S, Ketenci A, Sindel D. Effectiveness of transcranial direct current stimulation in chronic pain and neurogenic claudication related to lumbar spinal stenosis. Neurol Sci. 2024 Feb;45(2):769-782. doi: 10.1007/s10072-023-07248-z. Epub 2023 Dec 13.

  PMID: 38091212 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Enes Efe Is, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enes Efe Is, MD

CONTACT

+902124142000; enefeis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: May 22, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: October 31, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

TU (1)