Laser Diode Brace for Lower Back Pain After Spinal Fusion

Recruiting at 1 trial location

Overseen By Sandra Holley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Tumors, Infection, Drug misuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{4 5 6 7 8}

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. ^{1 3 5 6 9}

Who Is on the Research Team?

Sara K Chung, PA

Principal Investigator

University of California, Los Angeles

Sandra M Holley, PhD

Principal Investigator

University of California, Los Angeles

Sichen Li, PhD

Principal Investigator

University of California, Los Angeles

Adreanne Rivera, BS

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a randomized trial involving 61 patients with chronic low back pain, low level laser therapy combined with exercise showed significant long-term benefits, including a reduction in pain and improved lumbar range of motion compared to exercise alone.

At 12 weeks, the combination treatment resulted in a pain reduction of 1.8 cm, increased lumbar movement by 0.9 cm, and a decrease in disability by 9.4 points, indicating that laser therapy can enhance the effectiveness of exercise for managing chronic low back pain.

NCBI (Pubmed)

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. Djavid, GE., Mehrdad, R., Ghasemi, M., et al.[2022]

Photobiomodulation therapy (PBMT) showed no clinically important benefits in reducing pain and disability compared to sham treatment in individuals with acute/subacute or chronic non-specific low back pain, based on a systematic review of 12 randomized controlled trials involving 1,046 participants.

While PBMT was found to reduce pain and disability more than ultrasound, the differences were not deemed clinically significant, and it was less effective than Tecar therapy, indicating that current evidence does not support PBMT as an effective treatment for non-specific low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy does not decrease pain and disability in people with non-specific low back pain: a systematic review. Tomazoni, SS., Almeida, MO., Bjordal, JM., et al.[2022]

Systemic photobiomodulation is a cost-effective treatment for chronic low back pain, with an average cost of R$ 25.30 per session based on a study involving 20 nursing professionals.

The treatment involves 10 sessions using a specific laser equipment, and the majority of costs are attributed to labor (66%), making it a financially viable option compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic photobiomodulation in nursing professionals with chronic low back pain. Inocêncio, TDSC., Andraus, RAC., Ferrari, RAP., et al.[2023]

In a study of 100 patients with chronic low back pain, combining Ga-Al-As diode laser therapy (980 nm) with exercise significantly reduced pain more than exercise alone, with a notable average decrease in pain scores (3.96 vs. 2.23 on the visual analogue scale).

The treatment involved low-level laser therapy administered three times a week for three weeks, suggesting that this combination therapy could be an effective option in rehabilitation programs for managing nonspecific chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of diode laser in the treatment of patients with nonspecific chronic low back pain: a randomized controlled trial. Vallone, F., Benedicenti, S., Sorrenti, E., et al.[2022]

Laser photobiostimulation is an effective rehabilitation technique for spinal pain, providing analgesic and anti-inflammatory effects while also promoting tissue regeneration without age limitations or side effects.

This therapy is particularly important for individuals whose spinal pain affects their ability to work and engage in daily activities, highlighting the need for effective pain management in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of laser photobiostimulation as a factor supporting rehabilitation in spinal pain syndromes. Janiszewski, M., Furmańska-Rozlau, A.[2007]

In a study involving 10 patients with low back pain, those receiving photobiomodulation (PBM) therapy alongside physical therapy showed a significantly greater reduction in depression scores compared to those receiving physical therapy alone.

The improvement in depression was independent of changes in functional status, suggesting that PBM may have a direct antidepressant effect in patients with low back pain and concurrent depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case control series for the effect of photobiomodulation in patients with low back pain and concurrent depression. Gabel, CP., Petrie, SR., Mischoulon, D., et al.[2022]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

In a study of 75 patients with chronic low back pain, low power laser therapy (Gallium-Arsenide) was found to significantly reduce pain and improve functional disability, as measured by various clinical assessments.

All treatment groups, including those receiving laser therapy combined with exercise, laser therapy alone, and exercise alone, showed improvements, indicating that low power laser therapy is an effective option for managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low power laser therapy and exercise on pain and functions in chronic low back pain. Gur, A., Karakoc, M., Cevik, R., et al.[2022]

Low-level laser therapy (LLLT) showed statistically significant but clinically unimportant pain relief in some patients with non-specific low-back pain, based on a review of seven randomized controlled trials involving 168 participants.

While LLLT did not demonstrate superior effectiveness compared to exercise alone in reducing pain or disability, it was associated with a lower relapse rate at six months, and no side effects were reported, indicating a potential safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy for nonspecific low-back pain. Yousefi-Nooraie, R., Schonstein, E., Heidari, K., et al.[2022]

Citations

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]

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]

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

Systemic photobiomodulation in nursing professionals with chronic low back pain. [2023]

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]

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

An evaluation of laser photobiostimulation as a factor supporting rehabilitation in spinal pain syndromes. [2007]

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]

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]

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]

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

Low level laser therapy for nonspecific low-back pain. [2022]