Laser Diode Brace for Lower Back Pain After Spinal Fusion

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Disqualifiers: Tumors, Infection, Drug misuse, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Laser Diode Brace for Lower Back Pain After Spinal Fusion?

Research suggests that low-level laser therapy, when combined with exercise, can be more beneficial for chronic low back pain than exercise alone. Additionally, laser photobiostimulation has been shown to have pain-relieving and anti-inflammatory effects, making it a promising option for managing spinal pain.

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Is photobiomodulation therapy safe for humans?

Photobiomodulation therapy, also known as low-level laser therapy, has been used safely in humans for pain management and has shown analgesic (pain-relieving) and anti-inflammatory effects in various studies.

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How does the Laser Diode Brace treatment differ from other treatments for lower back pain after spinal fusion?

The Laser Diode Brace treatment is unique because it uses low-level laser therapy (LLLT), which involves light therapy to trigger biochemical changes in cells, potentially reducing pain and inflammation. This approach is different from traditional pain management methods as it combines laser therapy with exercise, offering a non-drug alternative for pain relief and healing.

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Eligibility Criteria

This trial is for individuals experiencing chronic lower back pain following spinal fusion and decompression surgery. Participants should be recovering from the surgery and looking for non-medication methods to manage pain and inflammation.

Inclusion Criteria

I am older than 18 years.

I have had minimally invasive surgery on my lower back.

I have had lower back pain for more than 3 months with a pain level above 4.

Exclusion Criteria

Drug misuse history

I am currently fighting an infection.

I have a severe spine condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operation

Participants complete pre-operation questionnaires including VAS and ODI to self-evaluate pain level and ability to perform basic lifestyle functions

1 week

Treatment

Participants receive a brace with or without laser diodes to wear 3 times/day for 12 minutes each session for 12 weeks

12 weeks

8 visits (virtual) for questionnaire submission and scar evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ongoing assessments of pain and scar healing

48 weeks

8 visits (virtual) for questionnaire submission and scar evaluation

Participant Groups

The study compares two types of braces: one with laser diodes that may reduce pain and inflammation, versus a sham (placebo) brace without active lasers. The effect on post-surgical wound healing will also be assessed.

Group I: Brace With Electrical Diodes Experimental Treatment 1 Intervention

The patient will be given a laser diode brace to wear for 1 year. At the defined time points following surgery (2, 4, 6, 8, 12, 24, 36 and 48 weeks), subjects will be asked to complete pain and ability-to-function questionnaires and submit scar/wound images to determine their status at each time interval.

Group II: Sham Brace Without Electrical Diodes Placebo Group 1 Intervention

The patient will be given a sham/placebo laser diode brace to wear for 1 year. At the defined time points following surgery (2, 4, 6, 8, 12, 24, 36 and 48 weeks), subjects will be asked to complete pain and ability-to-function questionnaires and submit scar/wound images to determine their status at each time interval.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCLA Clinical and Translational Research Center Los Angeles, CA

Semel Institute of Neuroscience at UCLA Los Angeles, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles Lead Sponsor

References

1. Australia pubmed.ncbi.nlm.nih.gov

In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomised trial. [2022] Is low level laser therapy an effective adjuvant intervention for chronic low back pain?

2. Netherlands pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy does not decrease pain and disability in people with non-specific low back pain: a systematic review. [2022] In people with non-specific low back pain (LBP), what are the effects of photobiomodulation therapy (PBMT) on pain, disability and other outcomes when compared with no intervention, sham PBMT and other treatments, and when used as an adjunct to other treatments?

3. Brazil pubmed.ncbi.nlm.nih.gov

Systemic photobiomodulation in nursing professionals with chronic low back pain. [2023] Chronic low back pain is a frequent complaint at health care services, leading to absenteeism and high treatment costs. Photobiomodulation is a cost-effective, non-pharmacological treatment option.

4. United States pubmed.ncbi.nlm.nih.gov

Effect of diode laser in the treatment of patients with nonspecific chronic low back pain: a randomized controlled trial. [2022] Low back pain is a common, highly debilitating condition, whose severity is variable. This study evaluated the efficacy of treatment with Ga-Al-As diode laser (980 nm) with a large diameter spot (32 cm(2)), in association with exercise therapy, in reducing pain.

5. Poland pubmed.ncbi.nlm.nih.gov

An evaluation of laser photobiostimulation as a factor supporting rehabilitation in spinal pain syndromes. [2007] Spinal pain can afflict both the sick and the healthy, even those with an anatomically correct spine. Such complaints force many people to change profession or even go on disability pension. Both the social and professional aspects are very important, then, in the rehabilitation of these people, since spinal pain syndromes impair the patient's locomotor capacity and his/her ability to work for a living. In view of this, medical rehabilitation takes on particular important, and especially the laser photobiostimulation technique in use for several years now. Biostimulating lasers have analgesis, anti-inflammatory, and antiallergenic effects, and relieve muscle cramps; they also improve metabolism and regenerate cells and tissue. Laser photobiostimulation is an effective, quick, aseptic therapy, with no age limitations or side effects.

6. Japan pubmed.ncbi.nlm.nih.gov

A case control series for the effect of photobiomodulation in patients with low back pain and concurrent depression. [2022] To present incidental findings in patients with low back pain (LBP) who received photobiomodulation (PBM) administered to the back and thighs as an adjunct to physical therapy (PT) and then experienced improvement in concurrent depression.

7. United States pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. [2019] Low-level laser therapy (LLLT) is a form of light therapy that triggers biochemical changes within cells. Photons are absorbed by cellular photoreceptors, triggering chemical alterations and potential biochemical benefits to the human body. LLLT has been used in pain management for years and is also known as cold laser therapy, which uses low-frequency continuous laser of typically 600 to 1000 nm wavelength for pain reduction and healing stimulation. Many studies have demonstrated analgesic and anti-inflammatory effects provided by photobiomodulation in both experimental and clinical trials.

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. [2022] The aim of this study was to determine whether low power laser therapy (Gallium-Arsenide) is useful or not for the therapy of chronic low back pain (LBP).

9. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy for nonspecific low-back pain. [2022] Low-back pain (LBP) is a major health problem and a major cause of medical expenses and disablement. Low level laser therapy (LLLT) can be used to treat musculoskeletal disorders such as back pain.