NCT04424823

LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses

Status unknown NA Last updated 30 June 2020

What this trial tests

NA trial testing LED photobiomodulation in Conditions for Lower Back Pain Working Nurse in 148 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
18 November 2020

18 November 2020

Quick facts

Lead sponsor	National Taiwan University Hospital Hsin-Chu Branch
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	148
Start date	1 July 2020
Primary completion	18 November 2020
Estimated completion	18 November 2020

Drugs / interventions tested

• LED photobiomodulation

Conditions studied

• Conditions for Lower Back Pain Working Nurse — all drugs for Conditions for Lower Back Pain Working Nurse →

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Who can join

Adults 18 to 65, any sex, with Conditions for Lower Back Pain Working Nurse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial.
   Lin YP, Su YH, Chin SF, Chou YC, et al · · 2020 · cited 10× · PMID 32769919 · DOI 10.1097/md.0000000000021611