Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060356) titled 'Verification of the Effectiveness of Far-Infrared Blood Circulation-Promoting Garments in Reducing Low Back Pain in Chronic Low Back Pain Cases' on Jan. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Morinomiya University of Medical Sciences

Condition: Condition - Non-specific chronic low back pain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Non-specific chronic low back pain refers to low back pain lasting over three months with no identifiable cause. Because the cause is unknown, treatment for non-specific chronic low back pain is often difficult and tends to become intractable. It is known that pain can cause changes in trunk muscle activity, abnormal stiffness, and reduced spinal mobility. There is a need for interventions to improve pain and functional impairment in such patients with non-specific chronic low back pain. Recently, far-infrared blood circulation-promoting garments have gained attention after being approved as general medical devices. The blood-circulation-promoting effect of far-infrared rays may help improve symptoms such as fatigue and muscle stiffness. However, general medical devices are defined as having little risk to human life or health, even if side effects or functional impairments occur. Therefore, the efficacy of these garments in alleviating symptoms in cases of nonspecific chronic low back pain is not yet fully established. This study aims to verify the intervention effects of wearing far-infrared blood circulation-promoting garments on lumbar back muscle tissue stiffness and function, spinal mobility, and low back pain in individuals with chronic nonspecific low back pain. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group wears innerwear with far-infrared blood circulation promotion effects for at least 8 hours daily during daytime hours for 4 weeks. The control group wears innerwear without far-infrared blood circulation promotion effects for at least 8 hours daily during daytime hours for 4 weeks. Interventions/Control_2 - The intervention group performed 10 to 15 minutes of trunk muscle exercises daily for 4 weeks while wearing innerwear with far-infrared blood circulation promotion effects. The control group performed 10 to 15 minutes of trunk muscle exercises daily for 4 weeks while wearing innerwear without far-infrared blood circulation promotion effects, identical to the intervention group.

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - Individuals experiencing low back pain on three or more days per week for three months or longer Key exclusion criteria - Individuals who can touch the floor with their palms during the standing forward bend test, cannot agree to refrain from initiating other pain relief therapies during the trial period, are pregnant or may be pregnant, have recently given birth or are breastfeeding, may exhibit allergic symptoms to the test product material, with skin abnormalities such as wounds, eczema, or irritation in areas where the test product will come into contact, with organic diseases such as herniated discs, experiencing numbness in the hands or feet, with a history of identified structural spinal abnormalities, with acute (painful) conditions such as spinal fractures or muscle strains, who have participated in another clinical trial within the past month or are currently participating in one, with a BMI of 28 or higher, presently receiving prescription medication for internal medical conditions, who cannot consent to the publication of trial footage for promotional purposes in a manner that prevents personal identification (e.g., by obscuring the face), currently receiving outpatient treatment for low back pain. Target Size - 84

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 11 Day Date of IRB - 2025 Year 12 Month 26 Day Anticipated trial start date - 2026 Year 01 Month 23 Day Last follow-up date - 2026 Year 03 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069045

Disclaimer: Curated by HT Syndication.