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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2024-10-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pharmacopuncture group

The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

Group Type EXPERIMENTAL

pharmacopuncture

Intervention Type 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 treatment group

The physicians will choose the type and time of physical therapy and if needed, pharmacological treatment according to participants' conditions.

Group Type ACTIVE_COMPARATOR

conservative treatments (including physiotherapy)

Intervention Type 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.

Interventions

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pharmacopuncture

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.

Intervention Type PROCEDURE

conservative treatments (including physiotherapy)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with lumbar spinal stenosis based on radiology including computed tomography 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 informed consent form.

Exclusion Criteria

1. Patients with vascular claudication
2. Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (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 or outcome interpretation
5. Patients who administrate those prescribed medicine that may interfere with interpretation 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 medicine intake, serious diabetes with risk of infection)
7. 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.
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 study enrollment, 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No