LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses
Primary Purpose
Conditions for Lower Back Pain Working Nurse
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LED photobiomodulation
Sponsored by
About this trial
This is an interventional treatment trial for Conditions for Lower Back Pain Working Nurse focused on measuring LED, LBP, photobiomodulation, nurse
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
LED
Sham
Arm Description
LED photobiomodulation therapy for the non-specific LBP working nurse
Shame group. The all procedure was same as the LED group but the LED ped was upside down without direct treatment.
Outcomes
Primary Outcome Measures
measure assessing change of Lumbar active range of motion between baseline to every time points
Including forward flexion, extension, and right and left rotations and were measured in degrees using a back range of motion instrument.
measure assessing change of 100-mm visual analog scale (VAS) between baseline to every time points
A 100-mm visual analog scale (VAS), which was used for low back pain assessment. The anchor terms of the VAS were 0 (no pain) and 10 (maximum pain imaginable). Higher VAS scores indicate greater pain intensity.
measure assessing change of Chair-rising time between baseline to every time points
Chair-rising time, wherein the time required for participants to rise five times from a seated position in a standard chair to a standing position as quickly as possible, without using their arms for support, was measured. A longer chair-rising time represents greater physical function limitations.
Secondary Outcome Measures
Full Information
NCT ID
NCT04424823
First Posted
June 3, 2020
Last Updated
June 26, 2020
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
1. Study Identification
Unique Protocol Identification Number
NCT04424823
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
November 18, 2020 (Anticipated)
Study Completion Date
November 18, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital Hsin-Chu Branch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conditions for Lower Back Pain Working Nurse
Keywords
LED, LBP, photobiomodulation, nurse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LED
Arm Type
Experimental
Arm Description
LED photobiomodulation therapy for the non-specific LBP working nurse
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Shame group. The all procedure was same as the LED group but the LED ped was upside down without direct treatment.
Intervention Type
Procedure
Intervention Name(s)
LED photobiomodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
measure assessing change of Lumbar active range of motion between baseline to every time points
Description
Including forward flexion, extension, and right and left rotations and were measured in degrees using a back range of motion instrument.
Time Frame
baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
Title
measure assessing change of 100-mm visual analog scale (VAS) between baseline to every time points
Description
A 100-mm visual analog scale (VAS), which was used for low back pain assessment. The anchor terms of the VAS were 0 (no pain) and 10 (maximum pain imaginable). Higher VAS scores indicate greater pain intensity.
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
Title
measure assessing change of Chair-rising time between baseline to every time points
Description
Chair-rising time, wherein the time required for participants to rise five times from a seated position in a standard chair to a standing position as quickly as possible, without using their arms for support, was measured. A longer chair-rising time represents greater physical function limitations.
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32769919
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.
Results Reference
derived
Learn more about this trial
LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses
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