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

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ClinicalTrials.gov Identifier: NCT03958526
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Enes Efe Is, Istanbul University

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.


Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Device: active tDCS Device: sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Active stimulation over M1
Device: 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.

Placebo Comparator: Sham
Sham stimulation over M1
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.




Primary Outcome Measures :
  1. Changes in Pain as measured by Visual Analog Scale [ Time Frame: 12 weeks ]
    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)) .

  2. Walking Duration and Distance [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Changes in Functional Status [ Time Frame: 12 weeks ]
    The investigators will use the Modified Oswestry Low Back Pain Disability Questionnaire to assess changes in functional status. The Modified Oswestry Disability Index (MODI) is a validated, 10-point patient-reported outcome questionnaire. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. A higher score indicates worse functional status.

  2. Changes in Quality of Life: Short Form-36 [ Time Frame: 12 weeks ]
    The investigators will use the Short Form-36 to assess changes in quality of life. The SF-36 is a 36-item self-report measure of health-related quality of life. It has eight subscales measuring different domains of health-related quality of life: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The SF-36 also includes a single item that assesses perceived change in health status over the past year. Higher scores on all subscales represent better health and functioning.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958526


Contacts
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Contact: Enes Efe Is, MD +902124142000 ext 31732 enefeis@gmail.com

Locations
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Turkey
Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation Recruiting
Istanbul, Turkey
Contact: Enes Efe Is, MD    +902124142000 ext 31732    enefeis@gmail.com   
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Enes Efe Is, MD Istanbul University

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Responsible Party: Enes Efe Is, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03958526     History of Changes
Other Study ID Numbers: LSS tDCS
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enes Efe Is, Istanbul University:
transcranial direct current stimulation
non-invasive brain stimulation
neuromodulation
chronic pain
neurogenic claudication
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Chronic Pain
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases