Tokyo, Jan. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060467) titled 'Effect of Spinal Mobility and Stability Improvement Exercises on Reducing Low Back Pain in Individuals with Chronic Low Back Pain' on Jan. 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Morinomiya University of Medical Sciences
Condition:
Condition - Nonspecific chronic low back pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Chronic nonspecific low back pain refers to low back pain lasting more than three months with no identifiable direct cause, and it tends to become refractory. Exercise therapy is considered adequate for chronic nonspecific low back pain, but the efficacy of specific exercises has not been demonstrated. Intervention methods vary and are left to the discretion of individual physical therapists. Therefore, there is a need for high-quality research showing the effectiveness of trunk exercise methods in consistently reducing low back pain symptoms in patients with nonspecific chronic low back pain. Consequently, the purpose of this study was to investigate the effects of a newly developed exercise program aimed at improving spinal mobility and stability on trunk function and on reducing low back pain in patients with chronic nonspecific low back pain.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention group performs exercises targeting spinal mobility and stability for 10-15 minutes daily.
Interventions/Control_2 - The control group performs general trunk exercises for 10-15 minutes daily.
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=R000069112
Disclaimer: Curated by HT Syndication.