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

NCT05242497 | Completed DMC

• 1 other identifier: JS-CT-2021-14
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 7

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  week 13

Secondary Outcomes (8)

• 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

• 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

• Oswestry disability index (ODI)

  week 1, 5, 9, 13, 25, 53

Study Arms (2)

pharmacopuncture group

EXPERIMENTAL

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

Procedure: pharmacopuncture

conservative treatment group

ACTIVE COMPARATOR

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

Procedure: conservative treatments (including physiotherapy)

Interventions

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.

pharmacopuncture group

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.

conservative treatment group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (7)

Dongguk University Bundang Oriental Hospital

Seongnam-si, Bundang-gu, 13601, South Korea

Location

Kyung Hee University Korean Medicine Hospital

Seoul, Dongdaemun-gu, 130-701, South Korea

Location

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36176963 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• In-Hyuk Ha, KMD, Ph.D

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 16, 2022
• Study Start: April 13, 2022
• Primary Completion: January 19, 2024
• Study Completion: October 28, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)