Back to resultsEffectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
active tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring transcranial direct current stimulation, non-invasive brain stimulation, neuromodulation, chronic pain, neurogenic claudication
Eligibility 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)
Sites / Locations
- Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Sham
Arm Description
Active stimulation over M1
Sham stimulation over M1
Outcomes
Primary Outcome Measures
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)) .
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.
Secondary Outcome Measures
Changes in Functional Status
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03958526
Brief Title
Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Official Title
Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
transcranial direct current stimulation, non-invasive brain stimulation, neuromodulation, chronic pain, neurogenic claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Active stimulation over M1
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
Sham stimulation over M1
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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 Measure Information:
Title
Changes in Pain as measured by Visual Analog Scale
Description
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)) .
Time Frame
12 weeks
Title
Walking Duration and Distance
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Functional Status
Description
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.
Time Frame
12 weeks
Title
Changes in Quality of Life: Short Form-36
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enes Efe Is, MD
Phone
+902124142000
Ext
31732
Email
enefeis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enes Efe Is, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enes Efe Is, MD
Phone
+902124142000
Ext
31732
Email
enefeis@gmail.com
12. IPD Sharing Statement
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Effectiveness of Transcranial Direct Current Stimulation in Chronic Pain Related to Lumbar Spinal Stenosis
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