Tokyo, Dec. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059670) titled 'Exercise intervention using behavior change techniques for low back pain in heavy manual workers: an exploratory study' on Dec. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Shimane University

Condition: Condition - Low back pain Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To explore the extent to which exercise interventions utilizing behavioral change techniques contribute to improvements in low back pain and related functional outcomes Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The initial intervention will be conducted within two weeks of registration. The intervention will last 12 weeks and will be delivered in a group format by a certified physical therapist in person. The intervention will utilize behavioral change techniques to support the practice of exercises (gymnastics) aimed at improving low back pain. As part of the behavioral change techniques, participants will be supported in setting specific, measurable behavioral goals. A monitoring sheet will be distributed for self-monitoring the frequency of back pain exercise practice, enabling monitoring and feedback. Additionally, group sessions will be held to convey accurate knowledge about back pain, exercise methods, and their effects, aiming to build knowledge. Interventions/Control_2 - Distribution of leaflets detailing exercises for low back pain

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Individuals experiencing lower back pain for over one month. 2. Individuals aged 20 to 60 years old. 3. Individuals engaged in heavy labor such as manufacturing, whose primary work duties do not involve desk work. 4. Individuals not currently receiving rehabilitation programs or hospital treatment for back pain at the time of registration. 5. Individuals who fully understand the study content and can provide written consent. Key exclusion criteria - 1. Individuals with a confirmed history of spinal disorders such as herniated discs, spinal stenosis, spinal compression fractures, spinal tumors, or infectious spondylitis. 2. Individuals currently restricted by a physician from exercise or physical activity due to low back pain or other health reasons. 3. Pregnant individuals or those who have undergone lumbar surgery within the past year. 4. Individuals with serious complications such as heart disease, respiratory disease, kidney disease, or liver disease, where participation in the study is deemed to potentially compromise safety. 5. Individuals with severe mental disorders (e.g., schizophrenia, major depressive disorder) that may make cooperation with or understanding of the study difficult. 6. Individuals who have difficulty communicating in Japanese. 7. Individuals deemed unsuitable for participation in this study by the research staff for other reasons. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 12 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068254

Disclaimer: Curated by HT Syndication.