Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis

Last updated: January 8, 2025
Sponsor: Jaseng Medical Foundation
Overall Status: Completed

Phase

N/A

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

pharmacopuncture

conservative treatments (including physiotherapy)

Clinical Study ID

NCT05242497
JS-CT-2021-14
  • Ages 19-69
  • All Genders

Study Summary

This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with lumbar spinal stenosis based on radiology including computedtomography or magnetic resonance imaging.

  2. Clear neurogenic claudication symptoms existed (symptoms aggravated with walking,and alleviated upon resting in lumbar flexion position).

  3. reported radiating leg pain or low back pain (LBP) with intensity of NRS ≥5

  4. Between the age of 19 and 69 years old.

  5. Participants who agreed to participate the study and voluntarily signed the informedconsent form.

Exclusion

Exclusion Criteria:

  1. Patients with vascular claudication

  2. Patients with pathologies of non-spinal origin that may cause LBP or radiating legpain (e.g. spinal tumor, fracture)

  3. Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g.tumor, fibromyalgia, rheumatoid arthritis, gout)

  4. Patients with other systemic diseases that may interfere with treatment effect oroutcome interpretation

  5. Patients who administrate those prescribed medicine that may interfere withinterpretation of the result (e.g. corticosteroids, immunosuppressants,physchotropic drugs)

  6. Patients for whom pharmacopuncture treatment may be inappropriate or unsafe (e.g.hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicineintake, serious diabetes with risk of infection)

  7. Patients who were treated with one of the following intervention within the pastweek; medicine that may potentially influence pain such as NSAIDs (nonsteroidalantiinflammatory drugs), pharmacopuncture, or physical therapies.

  8. Pregnant patients or patients planning pregnancy

  9. Patients with medical history of spinal surgery within the past 3 months

  10. Previous participation in other clinical studies within 1 month of current studyenrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment

  11. Patients unable to fill out study participation consent form

  12. Patients deemed unsuitable for study participation as assessed by the researchers

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: pharmacopuncture
Phase:
Study Start date:
April 13, 2022
Estimated Completion Date:
October 28, 2024

Study Description

This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments. The physician will decide specific location, type, and doses of pharmacopuncture therapy or conservative treatments according to each participants' disease conditions, respectively. The researcher will record concurrently.

Connect with a study center

  • Dongguk University Bundang Oriental Hospital

    Seongnam-si, Bundang-gu 13601
    Korea, Republic of

    Site Not Available

  • Dongguk University Bundang Oriental Hospital

    Seoul, Bundang-gu, Seongnam-si 13601
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Korean Medicine Hospital

    Seoul, Dongdaemun-gu 130-701
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Korean Medicine Hospital at Gangdong

    Seoul, Gangdong-gu 05278
    Korea, Republic of

    Site Not Available

  • Jaseng Hospital of Korean Medicine

    Seoul, Gangnam-Gu 135-896
    Korea, Republic of

    Site Not Available

  • Bucheon Jaseng Hospital of Korean Medicine

    Bucheon, Gyeonggi Province 14598
    Korea, Republic of

    Site Not Available

  • Haeundae Jaseng Hospital of Korean Medicine

    Busan,
    Korea, Republic of

    Site Not Available

  • Daejeon Jaseng Hospital of Korean Medicine

    Daejeon, 35262
    Korea, Republic of

    Site Not Available

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