LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses

• ClinicalTrials.gov Identifier: NCT04424823
• Recruitment Status: Unknown
• First Posted: June 11, 2020
• Last Update Posted: June 30, 2020
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch
• Information provided by (Responsible Party): Wei-Tso Chia MD PhD, National Taiwan University Hospital Hsin-Chu Branch

Tracking Information

• First Submitted Date: June 3, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: June 30, 2020
• Estimated Study Start Date: July 1, 2020
• Estimated Primary Completion Date: November 18, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2020)

• measure assessing change of Lumbar active range of motion between baseline to every time points [ Time Frame: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months ]
  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 [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months ]
  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 [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months ]
  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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Conditions for Lower Back Pain Working Nurse

Intervention

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.

Study Arms

• Experimental: LED
  LED photobiomodulation therapy for the non-specific LBP working nurse
  Intervention: Procedure: LED photobiomodulation
• Sham Comparator: Sham
  Shame group. The all procedure was same as the LED group but the LED ped was upside down without direct treatment.
  Intervention: Procedure: LED photobiomodulation

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 5, 2020): 148
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 18, 2020
• Estimated Primary Completion Date: November 18, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04424823
• Other Study ID Numbers: 108-088-F
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Wei-Tso Chia MD PhD, National Taiwan University Hospital Hsin-Chu Branch
• Original Responsible Party: Same as current
• Current Study Sponsor: National Taiwan University Hospital Hsin-Chu Branch
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: National Taiwan University Hospital Hsin-Chu Branch
• Verification Date: June 2020