Add-on effect and safety of pharmacopuncture therapy in the treatment of patients with lumbar spinal stenosis

Not Applicable

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0007229
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosed with lumbar spinal stenosis by CT or MRI.
- If there is no existing image data or if re-examination is necessary, L-spine CT scan will be performed
2. Pain or discomfort in the lower extremities/buttocks = VAS 40mm
3. Those who have clinical features of spinal stenosis, such as neurogenic claudication or changes in symptoms due to position
4. Those who are finally diagnosed with lumbar spinal stenosis as a result of a comprehensive physical examination, medical history examination, and imaging examination
5. Those who voluntarily decide to participate after hearing the explanation of the research purpose and process and consent in writing

Exclusion Criteria

1. Those who are diagnosed with congenital or developmental spinal stenosis
2. Those who have serious defects due to spinal canal problems such as spinal segment muscle atrophy, gait disorder, and Cauda equina syndrome
3. Those who are moderate to severe spinal malalignment and spinal instability due to spondylolisthesis, spondylolysis, thoracic and lumbar fractures, etc.
4. Those who are diagnosed with other spinal diseases such as vertebral body tumors, spinal infections, ankylosing spondylosis, etc.
5. History of spinal surgery such as spinal fusion or laminectomy
6. Those who have factors that may affect hemostasis, such as taking anticoagulants and antiplatelet drugs, and bleeding disorders
7. History of acupuncture hypersensitivity, metal allergy, severe atopic dermatitis, keloid skin, and other skin hypersensitivity
8. Those with moderate to severe chronic kidney disease (Chronic Kidney Disease stage = 4), uncontrolled diabetes mellitus, or severe cardiovascular disease
9. Those who have a significant neuropsychiatric history or who are currently mentally or cognitively unstable
10. History of alcoholism or drug abuse
11. Those who have a serious underlying disease who is receiving active treatment for it
12. Pregnant woman, lactating woman, or woman in childbearing years who plans on being pregnant
13. Those who can not write informed consent/data by themselves or under the supervision of a guardian/researcher
14. Those who are difficult to participate in the trial according to investigator's decision

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog scale(VAS)

Secondary Outcome Measures

Name	Time	Method
Zurich claudication questionaire (ZCQ);Maximum walking distance;Modified-Modified Schober Test(MMST) ;EuroQol-5D-5L index(EQ-5D-5L) ;Patient Global Impression of change (PGIC) ;Clinically important difference (CID);Safety assessment(Adverse effect)