Clinical trial NCT04424823: LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses
Official title: Light -Emitting Diode Photobiomodulation Therapy for Non-specific Low Back Pain in Working Nurses: A Single-center, Double-blind, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Conditions for Lower Back Pain Working Nurse
Keywords: LED
LBP
photobiomodulation
nurse
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* male or female registered nurses aged 18-65 years with non-specific chronic LBP, which is defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs, and persistent LBP for at least 3 months

Exclusion Criteria:

* severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis, and severe hives lupus)
* LBP associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes, and reflexes)
* serious spinal pathologies, such as fractures, tumors, and inflammatory and infectious diseases
* decompensated heart disease or metabolic disorders
* previous spinal surgery
* pregnancy.

Primary outcomes:
measure: measure assessing change of Lumbar active range of motion between baseline to every time points
timeFrame: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
measure: measure assessing change of 100-mm visual analog scale (VAS) between baseline to every time points
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
measure: measure assessing change of Chair-rising time between baseline to every time points
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lin YP, Su YH, Chin SF, Chou YC, Chia WT. Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial. Medicine (Baltimore). 2020 Aug 7;99(32):e21611. doi: 10.1097/MD.0000000000021611.