Back to resultsEffectiveness and Safety of Pharmacopuncture Therapy for Patients With Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
Primary Purpose
Lumbar Spinal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pharmacopuncture
conservative treatments (including physiotherapy)
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
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
- Patients unable to fill out study participation consent form
- Patients deemed unsuitable for study participation as assessed by the researchers
Sites / Locations
- Dongguk University Bundang Oriental HospitalRecruiting
- Kyung Hee University Korean Medicine HospitalRecruiting
- Kyung Hee University Korean Medicine Hospital at GangdongRecruiting
- Jaseng Hospital of Korean MedicineRecruiting
- Bucheon Jaseng Hospital of Korean MedicineRecruiting
- Haeundae Jaseng Hospital of Korean MedicineRecruiting
- Daejeon Jaseng Hospital of Korean MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pharmacopuncture group
conservative treatment group
Arm Description
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
The physicians will choose the type and time of physical therapy and if needed, pharmacological treatment according to participants' conditions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Numeric rating scale (NRS) of low back pain and radiating pain
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'.
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.
Walking distance
Claudication-free walking distance and maximal walking distance will be evaluated.
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.
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).
PGIC
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.)
Short Form-12 Health Survey version 2 (SF-12 v2)
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
EuroQol-5 Dimension (EQ-5D-5L)
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)
Full Information
NCT ID
NCT05242497
First Posted
February 15, 2022
Last Updated
June 13, 2023
Sponsor
Jaseng Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05242497
Brief Title
Effectiveness and Safety of Pharmacopuncture Therapy for Patients With Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
Official Title
Effectiveness and Safety of Pharmacopuncture Therapy for Patients With Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pharmacopuncture group
Arm Type
Experimental
Arm Description
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Arm Title
conservative treatment group
Arm Type
Active Comparator
Arm Description
The physicians will choose the type and time of physical therapy and if needed, pharmacological treatment according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
pharmacopuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conservative treatments (including physiotherapy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS)
Description
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 Outcome Measure Information:
Title
Numeric rating scale (NRS) of low back pain and radiating pain
Description
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'.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
Title
Visual analogue scale (VAS) of low back pain and radiating pain
Description
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
Title
Walking distance
Description
Claudication-free walking distance and maximal walking distance will be evaluated.
Time Frame
week 1, 5, 9, 13, 25, 53
Title
Zurich Claudication Questionnaire (ZCQ)
Description
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
Title
Oswestry disability index (ODI)
Description
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).
Time Frame
week 1, 5, 9, 13, 25, 53
Title
PGIC
Description
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.)
Time Frame
week 13, 25, 53
Title
Short Form-12 Health Survey version 2 (SF-12 v2)
Description
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Time Frame
week 1, 5, 9, 13, 25, 53
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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)
Time Frame
week 1, 5, 9, 13, 25, 53
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Patients unable to fill out study participation consent form
Patients deemed unsuitable for study participation as assessed by the researchers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In-Hyuk Ha, KMD, Ph.D
Phone
+82-2-2222-2740
Email
hanihata@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kyoung-Sun Park, Ph.D
Phone
+82-2-2222-2749
Email
lovepks0116@jaseng.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, KMD, Ph.D
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Dongguk University Bundang Oriental Hospital
City
Seoul
State/Province
Bundang-gu, Seongnam-si
ZIP/Postal Code
13601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunjung Kim, Professor
Facility Name
Kyung Hee University Korean Medicine Hospital
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
130-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongwoo Nam, Professor
Facility Name
Kyung Hee University Korean Medicine Hospital at Gangdong
City
Seoul
State/Province
Gangdong-gu
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeoncheol Park, Professor
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyoung Sun Park, Dr
Phone
+82-2-2222-2749
Email
lovepks0116@jaseng.co.kr
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi Province
ZIP/Postal Code
14598
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yeon Seo, KMD
Phone
82-2-2222-2745
Email
wownpan21@gmail.com
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Woo Cho, KMD
Email
kamui0328@jaseng.org
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
ZIP/Postal Code
35262
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunah Kim, KMD
Phone
+82-42-1577-0007
Email
tnsdk2648@jaseng.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36176963
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.
Results Reference
derived
Learn more about this trial
Effectiveness and Safety of Pharmacopuncture Therapy for Patients With Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
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