Spinal Fusion Clinical Trial
Official title:
Utilizing Photobiomodulation Via Laser Diode Belts To Treat Chronic Lower Back Pain in Patients Who Have Undergone Spinal Fusion and Decompression Surgery
After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients. Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Subject will have undergone minimally invasive spinal fusion surgery or spinal decompression surgery in their lower back L1-S1. - Have low back pain of >3 months and a pain threshold of > 4 (as described by the the subject), age > 18 years, and English speaking to eliminate possible miscommunication and consequent human error regarding belt use. - Subject must have had surgery at minimum to 1 year prior to start of study and no more than 5 years prior to start to study Exclusion Criteria: - Patients with tumors - Current infection - Drug misuse history - Skin conditions preclude the use of laser belt - Severe spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis - Previous low back surgery exceeding 5 years to initial start date. |
Country | Name | City | State |
---|---|---|---|
United States | Semel Institute of Neuroscience at UCLA | Los Angeles | California |
United States | UCLA Clinical and Translational Research Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS | Subjects will fill out two questionnaires related to their pain and quality of life before and after surgery with laser diode brace photobiomodulation therapy.
The first survey is the Visual Analog Scale (VAS), which asks subjects to state how good or bad their current health state is on a scale of 0-100, 1 being the worst imaginable health state and 100 being the best imaginable health state. There are two additional questions that ask subjects to provide a rate their current back and leg pain on a scale of 0-10, with 0 being no pain and 10 being worst imaginable pain. |
1 year | |
Primary | Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI | The second survey is the Oswestry Disability Index (ODI), which is designed to provide information on how the subject's pain is affecting their everyday life. There are 10 sections on the survey each graded on a scale from 0-5 with 5 being the most impaired. The total score scales from 0-50, where 0-10 denotes minimal disability and 40-50 denotes that the pain impinges on all aspects of their daily lives. | 1 year | |
Secondary | Stony Brook Scar Evaluation | Surgical scar healing will be examined to see if there is any promotion of wound healing due to the therapeutic advantage from the brace photobiomodulation therapy. Assessments include scar/wound size (in mm) and scar/wound healing using the Image J software.
The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing. |
1 Year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04037059 -
Impact of Body Habitus (Arm Span and Abdominal Girth) on Activities of Daily Living (ADL)
|
||
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Not yet recruiting |
NCT06003010 -
Yoga for Adolescent Idiopathic Scoliosis (AIS) Patients
|
N/A | |
Completed |
NCT01235650 -
Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT03459404 -
Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
|
||
Recruiting |
NCT05010148 -
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
|
Phase 3 | |
Recruiting |
NCT04605120 -
Allogeinic Bone Paste
|
N/A | |
Completed |
NCT03826329 -
Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion
|
||
Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
Recruiting |
NCT05323448 -
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
|
N/A | |
Completed |
NCT00994656 -
Is Pleth Variability Index (PVI) a Surrogate for Pulse Pressure Variations (PPV) in Pediatric Spine Fusion (SF) Surgery?
|
N/A | |
Completed |
NCT00152152 -
Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
|
N/A | |
Terminated |
NCT03425799 -
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
|
Phase 3 | |
Not yet recruiting |
NCT06368245 -
Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
|
||
Withdrawn |
NCT03908203 -
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
|
N/A | |
Terminated |
NCT03378973 -
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
|
Phase 4 | |
Completed |
NCT05936047 -
Bone Marrow Clot for Posterior Lumbar Fusion
|
N/A | |
Not yet recruiting |
NCT03692845 -
Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion
|
N/A | |
Completed |
NCT00152165 -
Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System
|
N/A |