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NCT Number: NCT05242497

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

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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Bundang Oriental Hospital, Seongnam-si, Bundang-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
  • Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
  • reported radiating leg pain or low back pain (LBP) with intensity of NRS ≥5
  • Between the age of 19 and 69 years old.
  • Participants who agreed to participate the study and voluntarily signed the informed consent form.

Exclusion criteria

  • Patients with vascular claudication
  • Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
  • Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
  • Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
  • Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
  • Patients for whom pharmacopuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection)
  • Patients who were treated with one of the following intervention within the past week; medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs), pharmacopuncture, or physical therapies.
  • Pregnant patients or patients planning pregnancy
  • Patients with medical history of spinal surgery within the past 3 months
  • Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
  • Patients unable to fill out study participation consent form
  • Patients deemed unsuitable for study participation as assessed by the researchers

Treatment and study plan

Pharmacopuncture

Procedure

This is a pragmatic randomized controlled trials, so the physicians will choose pharmacopuncture treatment, including the type and doses, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently.

conservative treatments (including physiotherapy)

Procedure

This is a pragmatic randomized controlled trials, so the physicians will choose conservative treatment, including physiotherapy and pharmacological treatment, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently.

Primary outcomes

  1. Numeric rating scale (NRS)

    Time frame: week 13

    NRS is a pain scale in which the patients indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. The NRS of major painful site, which was chosen between low back and radiation pain in lower extremities, will be reported.

Secondary outcomes

  1. Numeric rating scale (NRS) of low back pain and radiating pain

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53

    NRS is a pain scale in which the patients indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  2. Visual analogue scale (VAS) of low back pain and radiating pain

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53

    The patient indicates their pain severity from minimum 0 to maximum 100, which is a higher score means a worse outcome. VAS of low back pain and radiating leg pain will be reported.

  3. Walking distance

    Time frame: week 1, 5, 9, 13, 25, 53

    Claudication-free walking distance and maximal walking distance will be evaluated.

  4. Zurich Claudication Questionnaire (ZCQ)

    Time frame: week 1, 5, 9, 13, 25, 53

    ZCQ is a lumbar spinal stenosis-specific patient reported outcome, which evaluate the disease severity, functional scale and satisfaction at the treatment.

  5. Oswestry disability index (ODI)

    Time frame: week 1, 5, 9, 13, 25, 53

    ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).

  6. PGIC

    Time frame: week 13, 25, 53

    Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)

  7. Short Form-12 Health Survey version 2 (SF-12 v2)

    Time frame: week 1, 5, 9, 13, 25, 53

    The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.

  8. EuroQol-5 Dimension (EQ-5D-5L)

    Time frame: week 1, 5, 9, 13, 25, 53

    The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2022
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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