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

Jaseng Medical Foundation98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lumbar Spinal Stenosis

Interventions

pharmacopuncturePROCEDURE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (7)

Dongguk University Bundang Oriental Hospital

Seongnam-si, Bundang-gu, South Korea

Kyung Hee University Korean Medicine Hospital

Seoul, Dongdaemun-gu, South Korea

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, South Korea

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

Numeric rating scale (NRS)

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.

Time frame: week 13

Secondary Outcomes

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

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

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.

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

Walking distance

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

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

Zurich Claudication Questionnaire (ZCQ)

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

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

Oswestry disability index (ODI)

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.