Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- Jaseng Medical Foundation
- Enrollment
- 98
- Locations
- 7
- Primary Endpoint
- Numeric rating scale (NRS)
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Visual analogue scale (VAS) of low back pain and radiating pain(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53)
- Walking distance(week 1, 5, 9, 13, 25, 53)
- Zurich Claudication Questionnaire (ZCQ)(week 1, 5, 9, 13, 25, 53)
- PGIC(week 13, 25, 53)
- Short Form-12 Health Survey version 2 (SF-12 v2)(week 1, 5, 9, 13, 25, 53)
- Numeric rating scale (NRS) of low back pain and radiating pain(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53)
- Oswestry disability index (ODI)(week 1, 5, 9, 13, 25, 53)
- EuroQol-5 Dimension (EQ-5D-5L)(week 1, 5, 9, 13, 25, 53)