Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062047) titled 'Study on the Duration of Effects of Different Trigger Point Acupuncture Stimulation Methods on Pain Sensitivity' on June 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kansai University of Health Sciences
Condition:
Condition - Chronic Low Back Pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to compare the persistence of the analgesic effects of 10-minute needle retention and sparrow-pecking stimulation at trigger points on peripheral sensitization using pressure pain threshold as an outcome measure.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Acupuncture stimulation will be applied to a trigger point at which symptom reproduction is confirmed by manual compression. After needle insertion, the needle will be retained in situ for 10 minutes without additional manual stimulation and then removed.
Interventions/Control_2 - Acupuncture stimulation will be applied to a trigger point at which symptom reproduction is confirmed by manual compression. After needle insertion, sparrow-pecking manipulation will be performed for a predetermined period, followed by needle removal.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Adults aged 18~65 years.
Students or employees of the university.
Individuals with chronic low back pain lasting for at least 3 months.
No history of lumbar spine surgery.
No symptoms suggestive of lower extremity radiculopathy.
Reproduction of their usual low back pain upon manual compression of the lumbar multifidus muscle, including the area approximately 2 cm lateral to the midline at the L4 vertebral level.
Ability to reliably report symptom reproduction during acupuncture stimulation.
Previous experience with acupuncture treatment.
Provision of written informed consent.
Key exclusion criteria - Individuals with severe fear of acupuncture treatment.
Individuals who have previously experienced all acupuncture stimulation as strongly unpleasant or painful sensations.
Pregnant women or individuals who may be pregnant.
Individuals with bleeding disorders or those receiving anticoagulant therapy.
Individuals with severe orthopedic, neurological, or psychiatric disorders.
Individuals deemed unsuitable for study participation by the principal investigator.
Target Size - 30
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 12 Month 19 Day
Date of IRB - 2025 Year 12 Month 19 Day
Anticipated trial start date - 2025 Year 12 Month 19 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070995
Disclaimer: Curated by HT Syndication.