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

Not Applicable

Completed

Conditions: Diseases of the musculoskeletal system and connective tissue

Registration Number: KCT0002903

Lead Sponsor: Pusan National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

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

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.)

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distance between the waist and ankle in the primary somatosensory area using functional magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
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