Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with tumors
Current infection
Drug misuse history
Skin conditions preclude the use of laser belt
Trial design
Design model
Parallel
Treatments tested in this trial
Laser Diode Brace
DeviceThe device is a brace with laser diodes. The braces light up and the red light has therapeutic abilities.
Sham Laser Diode Brace
DeviceThe Sham brace has no therapeutic ability and will act as a placebo.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Brace With Electrical DiodesExperimental treatment 1 intervention
Group B: Sham Brace Without Electrical DiodesSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
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.
Time frame
3 monthsSecondary outcomes
1
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.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov