Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03958526|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
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
|Contact: Enes Efe Is, MD||+902124142000 ext email@example.com|
|Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation||Recruiting|
|Contact: Enes Efe Is, MD +902124142000 ext 31732 firstname.lastname@example.org|
|Principal Investigator:||Enes Efe Is, MD||Istanbul University|