Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062044) titled 'Effects of Trigger Point Acupuncture on Pain Sensitivity in Individuals with Chronic Low Back Pain' on June 24.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
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 investigate the effects of trigger point acupuncture and electroacupuncture applied to ultrasound-identified myofascial pain-related tissues on peripheral sensitization in patients with chronic low back pain. Pressure pain threshold will be assessed as an indicator of peripheral sensitization, and changes will be compared among acupuncture, electroacupuncture, and no-treatment control conditions.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Two disposable stainless-steel acupuncture needles will be inserted into trigger points within the lumbar multifidus muscle identified using ultrasonography and retained in situ for 10 minutes.
Interventions/Control_2 - Two disposable stainless-steel acupuncture needles will be inserted into trigger points within the lumbar multifidus muscle identified using ultrasonography, and low-frequency electrical stimulation will be applied between the needles for 10 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 L4,5 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 - Completed
Date of protocol fixation - 2024 Year 07 Month 11 Day
Date of IRB - 2024 Year 07 Month 22 Day
Anticipated trial start date - 2024 Year 07 Month 11 Day
Last follow-up date - 2026 Year 06 Month 24 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070993
Disclaimer: Curated by HT Syndication.