Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062046) titled 'Effects of Different Acupuncture Retention Times at Trigger Points on Pain Sensitivity in Individuals with Chronic Low Back Pain' 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 investigate the effects of different acupuncture stimulation durations on peripheral sensitization in patients with chronic low back pain. Acupuncture will be applied under ultrasound guidance to tissues associated with symptom reproduction identified at sites where pressure provokes the patient's typical low back pain. Pressure pain threshold will be assessed as an indicator of peripheral sensitization, and changes will be compared among different stimulation-duration conditions.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and removed immediately after insertion.
Interventions/Control_2 - A disposable stainless-steel acupuncture needle will be inserted into the symptom-reproducing tissue identified using ultrasonography and retained for 1 minute.
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 - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 08 Month 31 Day
Date of IRB - 2023 Year 08 Month 31 Day
Anticipated trial start date - 2023 Year 08 Month 31 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=R000070994
Disclaimer: Curated by HT Syndication.