Tokyo, June 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062066) titled 'Comparison of the Effects of Different Acupuncture Sites on Pain in People with Chronic Low Back Pain' on June 27.
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 effects of acupuncture stimulation at active trigger points and non-trigger point sites on quantitative sensory testing (pressure pain threshold and temporal summation) and pain intensity in patients with chronic low back pain, thereby clarifying the characteristics of the analgesic effects of trigger point acupuncture.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Under ultrasound guidance, a disposable stainless steel needle is inserted into the tissue within the lumbar multifidus where reproduction of the participant's usual low back pain was confirmed during the pre-assessment, and retained for 15 minutes.
Interventions/Control_2 - nder ultrasound guidance, a disposable stainless-steel needle is inserted 10 mm shallower than the tissue where pain reproduction was identified during the pre-assessment, with the absence of symptom reproduction confirmed, and retained for 15 minutes.
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 - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2020 Year 10 Month 21 Day
Date of IRB - 2020 Year 10 Month 21 Day
Anticipated trial start date - 2020 Year 10 Month 21 Day
Last follow-up date - 2025 Year 09 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071020
Disclaimer: Curated by HT Syndication.