Effects of acupuncture on the signal changes in the brain imaging for patients with lumbar disc herniation or lumbar spinal stenosis with radiating leg pain

Effects of acupuncture on the signal changes in the primary sensory cortex for patients with lumbar disc herniation or lumbar spinal stenosis with radiating leg pain: a parallel randomised controlled multicentre exploratory trial and a cross-sectional study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002903

Enrollment

Registered

2018-05-31

Start date

2018-06-07

Completion date

Unknown

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This study is a randomised, controlled, patient-assessor blinded, parallel design, multicentre trial. Participants assigned to the experimental group (real acupuncture group) or the c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient group 1) 19 to 75 years 2) Over 3 months after diagnosis of lumbar disc herniation or lumbar spinal stenosis. 3) Patient who submits document proving selection criterion 2). 4) Radiating leg pain numeric rating scale score of at least 4 over the last week. 5) Voluntary written consent to the subject consent form. 2. Normal group 1) 30 to 75 years 2) No back pain and lower back pain over the last 3 months 3) No other pain 4) MRI (magnetic resonance imaging) available

Exclusion criteria

Exclusion criteria: 1. Patient group 1) History/Current history of fracture, tumor or infection of lumbar spine 2) Those who need emergency surgery due to cauda equina syndrome or those with neurological abnormalities lasting 1 month. 3) Those who have undergone surgery on the back area 4) Those who have been treated for lumbar disc herniation or lumbar spinal stenosis within one week of the screening visit 5) MRI examination not possible 6) Seriously unstable medical condition or serious psychiatric illness 7) Diseases that cause brain damage or severe pain 8) Psychotropic drugs (excluding non-toxic analgesics) 9) Pregnant women, nursing mothers 10) Hypersensitivity to acupuncture 11) Participating in other clinical studies 12) Residents of collective dwelling facilities such as social welfare institutions 13) Difficult to cooperate in the research process. 2. Normal group 1) Pregnant women, nursing mothers 2) Participating in other clinical studies 3) Diseases that cause brain damage or severe pain 4) Drugs that affect brain activation (psychotropic medications, antipyretics, etc.)

Design outcomes

Primary

Measure	Time frame
The distance between the waist and ankle in the primary somatosensory area using functional magnetic resonance imaging	—

Secondary

Measure	Time frame
Functional brain imaging;Structural brain imaging;Two-point discrimination test;Oswestry disability index;Back pain intensity numeric rating scale;Radiating leg pain intensity numeric rating scale;Responders using radiating leg pain intensity numeric rating scale;Use of medications;Patient global impression of change;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactYU KYUNG SHIN

Pusan National University Hospital

gyon.2@daum.net+82-51-240-6891

Outcome results