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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
National Taiwan University Hospital Hsin-Chu Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 3, 2020
    Last Updated
    June 26, 2020
    Sponsor
    National Taiwan University Hospital Hsin-Chu Branch
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    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

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    LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses

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