Clinical trial NCT05242497: Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis
Official title: Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 98
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: week 13
Secondary outcomes:
measure: Numeric rating scale (NRS) of low back pain and radiating pain
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
measure: Visual analogue scale (VAS) of low back pain and radiating pain
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
measure: Walking distance
timeFrame: week 1, 5, 9, 13, 25, 53
measure: Zurich Claudication Questionnaire (ZCQ)
timeFrame: week 1, 5, 9, 13, 25, 53
measure: Oswestry disability index (ODI)
timeFrame: week 1, 5, 9, 13, 25, 53
measure: PGIC
timeFrame: week 13, 25, 53
measure: Short Form-12 Health Survey version 2 (SF-12 v2)
timeFrame: week 1, 5, 9, 13, 25, 53
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: week 1, 5, 9, 13, 25, 53
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
state: Bundang-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital at Gangdong
state: Gangdong-gu
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD, Ph.D
role: STUDY_DIRECTOR
References:
citation: Lee JY, Park KS, Kim S, Seo JY, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study. J Pain Res. 2022 Sep 23;15:2989-2996. doi: 10.2147/JPR.S382550. eCollection 2022.