LED Photobiomodulation Therapy for Non-specific LBP in Working Nurses

NCT04424823 | Unknown DMC

• 1 other identifier: 108-088-F
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Conditions for Lower Back Pain Working Nurse

Keywords

LED; LBP; photobiomodulation; nurse

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months

• 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.

  2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months

• 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.

  2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months

Study Arms (2)

LED

EXPERIMENTAL

LED photobiomodulation therapy for the non-specific LBP working nurse

Procedure: LED photobiomodulation

Sham

SHAM COMPARATOR

Shame group. The all procedure was same as the LED group but the LED ped was upside down without direct treatment.

Procedure: LED photobiomodulation

Interventions

LED photobiomodulation PROCEDURE

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.

LED; Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Related Publications (1)

• 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.

  PMID: 32769919 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Deputy Director of Orthopaedics Department

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share