Conditions for Lower Back Pain Working Nurse Clinical Trial
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
| Verified date | June 2020 |
| Source | National Taiwan University Hospital Hsin-Chu Branch |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 148 |
| Est. completion date | November 18, 2020 |
| Est. primary completion date | November 18, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital Hsin-Chu Branch |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |