NCT04424823

LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses

Light -Emitting Diode Photobiomodulation Therapy for Non-specific Low Back Pain in Working Nurses: A Single-center, Double-blind, Prospective, Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Background: Low back pain (LBP) affects approximately 51-57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP. Methods and analysis: The investigators conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to two groups: intervention group, where patients received LED photobiomodulation therapy three times a week for 2 weeks, and the control group, where patients had sham treatment only three times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a Multidimensional Fatigue Inventory, Fear-Avoidance Beliefs Questionnaire, and the Oswestry Disability Index. The outcome measures were assessed before therapy and 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed. Discussion: This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. The results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain. Trial registration number: This protocol was registered in ClinicalTrials.gov, under the number 108-088-F.

Conditions

• Conditions for Lower Back Pain Working Nurse

Interventions

Type	Name	Description
PROCEDURE	LED photobiomodulation	Patients were submitted to photobiomodulation therapy with wavelengths of both 630-nm and 850-nm for RED and near-infrared LEDs, with power density set to 8.5 mW/cm2 and 12.5 mW/cm2, respectively. The LED device (name of device, Applied BioPhotonics) was designed in Silicon Valley, United States, and was approved by the United States Food and Drug Administration for the treatment of minor muscle and joint pain. LED therapy was applied by placing the device on the skin at a 90° angle. Both groups underwent six times therapy sessions (i.e., three times a week for 2 weeks), and during the therapy, only the researcher in charge of programming the LED device was aware of the treatment employed; the programmer did not participate in the execution of the treatments, evaluations, or data analysis.

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2020-06-11
• Last updated: 2020-06-30