Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
This study is looking into a treatment called tSpinalStim for people with chronic low back pain. tSpinalStim uses electrical stimulation on the skin over your spine to help reduce pain. Researchers want to see if this treatment can improve your pain levels, measured by a Visual Analogue Scale (VAS) score, and how your body moves, specifically your posture and lower back flexibility. You might be able to join if you are between 21 and 85 years old, have low back pain, and can get out of a chair on your own. You also need to have stable medication doses for two weeks before joining. However, you cannot participate if you have a high Body Mass Index (BMI) over 28, have hardware in your spine from past surgeries, or have other types of nerve pain. The study plans to enroll 50 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 50 participants. The study does not specify if it is randomized or blinded.
- What's involved
- You would undergo 12 to 21 sessions of spinal cord stimulation therapy, with each session lasting 30 minutes, three times a week. Measurements for pain and movement will be taken at 3 hours.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain and movement will be measured at 3 hours after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anastasia Keller, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Jeannie Bailey, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Visual Analogue Scale (VAS) score3 hours
A patient reported outcome of pain; will be assessed by presenting a VAS tool with the scale of 0 -10, 0 - being no pain and 10 the worst pain imaginable. VAS scores will be collected before and after the intervention
- Max Sagittal Vertical Axis3 hours
A kinematic variable that measures body flexion (degrees) relative to the vertical sagittal axis (virtual straight line through the midline of the body) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement
- L5S1/Torso Max Flex/Ext angle3 hours
A kinematic variable that measures torso/L5S1 joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement. The maximum flexion and extension will be compared between baseline and post-intervention.
- L5S1/Torso Max velocity3 hours
A kinetic variable that measures torso/L5S1 velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement. The maximum velocities will be compared between baseline and post-intervention.
- Hip/Pelvis Max Flex/Ext angle3 hours
A kinematic variable that measures pelvis/hip joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.
- Hip/Pelvis Max velocity3 hours
A kinematic variable that measures pelvis/hip joint velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum velocity will be compared between baseline and post-intervention.
- Thing/Knee Max Flex/Ext angle3 hours
A kinetic variable that measures thigh/knee joint flexion and extension (degrees) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.
- Thing/Knee Max Velocity3 hours
A kinetic variable that measures thigh/knee joint velocity (m/s) assessed using Kinect-2 depth camera while subject performs 3-5 trials of sit-to-stand movement The maximum flexion and extension will be compared between baseline and post-intervention.
- Insula - Cingulate connectivity3 hours
A neuroimaging outcome variable that measures functional connectivity (Fisher z-scores, Fz) between the Insula - and Cingulate brain regions. Patients will undergo brain functional magnetic resonance imaging (fMRI) scan before and after intervention. Fz scores will be compared between baseline and post-intervention
- Default Mode Network connectivity3 hours
A neuroimaging outcome variable that measures functional connectivity (Fisher-z scores, Fz) of the brain default mode network. Patients will undergo brain functional magnetic resonance imaging (fMRI) fMRI scan before and after intervention. Fz scores will be compared between baseline and post-intervention
- Erector Spinae activation (Root Mean Square)3 hours
Erector Spinae (ES) activation will be measured using surface electromyography (EMG) recorded with bilateral EMG electrodes placed at L5 levels while patient performs 3-5 trials of sit-to-stand (concomitant with biomechanics assessment). The root mean square will be calculated during the time period it take the patient to completed sit-to-stand transition (from lift off from the chair to standing)
- Rectus Femoris activation (Root Mean Square)3 hours
Rectus femoris (ES) activation will be measured using surface electromyography (EMG) recorded with bilateral EMG electrodes placed on top of the muscle belly at mid thigh while patient performs 3-5 trials of sit-to-stand (concomitant with biomechanics assessment). The root mean square will be calculated during the time period it take the patient to completed sit-to-stand transition (from lift off from the chair to standing)