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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

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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)) .
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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 amaximum score of 50. The total score is then converted into a percentage by multiplying it by 2. A higher score indicates worse functional status.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Official Title  ICMJE Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spinal Stenosis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Active
    Active stimulation over M1
    Intervention: Device: active tDCS
  • Placebo Comparator: Sham
    Sham stimulation over M1
    Intervention: Device: sham tDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Enes Efe Is, MD +902124142000 ext 31732 enefeis@gmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958526
Other Study ID Numbers  ICMJE LSS tDCS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enes Efe Is, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enes Efe Is, MD Istanbul University
PRS Account Istanbul University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP