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

January 8, 2025 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Haeundae Jaseng Hospital of Korean Medicine
      • Daejeon, Korea, Republic of, 35262
        • Daejeon Jaseng Hospital of Korean Medicine
    • Bundang-gu
      • Seongnam-si, Bundang-gu, Korea, Republic of, 13601
        • Dongguk University Bundang Oriental Hospital
    • Dongdaemun-gu
      • Seoul, Dongdaemun-gu, Korea, Republic of, 130-701
        • Kyung Hee University Korean Medicine Hospital
    • Gangdong-gu
      • Seoul, Gangdong-gu, Korea, Republic of, 05278
        • Kyung Hee University Korean Medicine Hospital at Gangdong
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
        • Jaseng Hospital of Korean Medicine
    • Gyeonggi Province
      • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
        • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: pharmacopuncture group
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Procedure: 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.
Active Comparator: conservative treatment group
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
week 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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'.
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
Time Frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
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.
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
Walking distance
Time Frame: week 1, 5, 9, 13, 25, 53
Claudication-free walking distance and maximal walking distance will be evaluated.
week 1, 5, 9, 13, 25, 53
Zurich Claudication Questionnaire (ZCQ)
Time Frame: week 1, 5, 9, 13, 25, 53
ZCQ is a lumbar spinal stenosis-specific patient reported outcome, which evaluate the disease severity, functional scale and satisfaction at the treatment.
week 1, 5, 9, 13, 25, 53
Oswestry disability index (ODI)
Time Frame: week 1, 5, 9, 13, 25, 53
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).
week 1, 5, 9, 13, 25, 53
PGIC
Time Frame: week 13, 25, 53
Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
week 13, 25, 53
Short Form-12 Health Survey version 2 (SF-12 v2)
Time Frame: week 1, 5, 9, 13, 25, 53
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
week 1, 5, 9, 13, 25, 53
EuroQol-5 Dimension (EQ-5D-5L)
Time Frame: week 1, 5, 9, 13, 25, 53
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
week 1, 5, 9, 13, 25, 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: In-Hyuk Ha, KMD, Ph.D, Jaseng Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-CT-2021-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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