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Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized, controlled, pilot clinical trial

Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized, controlled, pilot clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006234
Enrollment
40
Registered
2021-06-09
Start date
2021-05-17
Completion date
Unknown
Last updated
2021-06-24

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

Conditions

None listed

Interventions

Procedure/Surgery : The experimental group is received twice per week(one with acupotomy and usual care, and the other one with only usual care) and total 16 times during 8 weeks. Active comparator is

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with lumbar spinal stenosis by CT or MRI. 2. Have back pain or lower extremity pain for at least 3 months. 3. Aged 50–80 years 4. VAS is between 4 and 7. 5. Have no problem with language, expression, and concentration. 6. Follow-up possible during the clinical trial 7. Voluntarily signed an agreement to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Have side effect or a history of hypersensitivity to acupuncture treatment. 2. Need severe surgical treatment for neurological symptoms of cauda equine syndrome, sensory or motor paralysis. 3. Had a spinal surgery prior to the clinical trial. 4. Have been treated for Epidural nerve block within 3 months. 5. Have neuromuscular scoliosis or neurodegenerative diseases. 6. More than three times the normal category in the liver function test (SGOT, SGPT) 7. Abnormal kidney function test 8. Have a history of neurological or psychologically important medical history or currently suffers from a related condition. 9. Pregnant women, lactating women, women who have plans to conceive or do not agree with appropriate contraception options. 10. Take a anticoagulant medication. 11. Inserted the artificial pacemaker. 12. Other people regarded inappropriate by the person in charge of clinical trial.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale(VAS)

Secondary

MeasureTime frame
Self-rated walking distance;Short form McGill pain questionnaire;Oswestry Disability Index;Blood test and biochemistry test

Countries

Korea, Republic of

Contacts

Public ContactJUNGHEE LEE

Daegu Oriental Hospital of Daegu Haany University

atleejh@naver.com+82-53-770-2118

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 9, 2026