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The effect of comprehensive and integrative medicine in patients with lumbar spinal stenosis - randomized control study (pilot study)

Status Approved

  • First Submitted Date

    2021/01/29

  • Registered Date

    2021/03/29

  • Last Updated Date

    2021/03/12

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006036
    Unique Protocol ID CR-20-205-L
    Public/Brief Title The effect of comprehensive and integrative medicine in patients with lumbar spinal stenosis - randomized control study (pilot study)
    Scientific Title The effect of comprehensive and integrative medicine in patients with lumbar spinal stenosis - randomized control study (pilot study)
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CR-20-205-L
    Approval Date 2020-12-16
    Institutional Review Board Name Institutional Review Board of Daegu Catholic University
    Institutional Review Board Address 33, Duryugongwon-ro 17-gil, Nam-gu, Daegu
    Institutional Review Board Telephone 053-650-4423
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Gwak Sanggyu
    Title assistant professor
    Telephone +82-53-650-4724
    Affiliation Daegu Catholic University
    Address 33, Duryugongwon-ro 17-gil, Nam-gu, Daegu, Republic of Korea
    Contact Person for Public Queries
    Name chung hyeonjung
    Title associate professor
    Telephone +82-53-670-5932
    Affiliation Daegu Oriental Hospital of Daegu Haany University
    Address 136, Sincheondong-ro, Suseong-gu, Daegu, Republic of Korea
    Contact Person for Updating Information
    Name Kim Somi
    Title CRC
    Telephone +82-53-670-5981
    Affiliation Comprehensive & Integrative Medicine Hospital
    Address 77 Duryu Park, Nam-gu, Daegu
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-01-21 Actual
    Target Number of Participant 30
    Primary Completion Date 2021-11-30 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Daegu Catholic University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2021-01-21 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID HI20C1753010220
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daegu Catholic University Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    <Background>
    Lumbar spinal stenosis is a typical degenerative disease of the spine that complains of lower extremities, back pain, hip joint pain, and walking disorders. The lower extremities and connections in the hips usually occur in the hip or waist area. This pain is a pain that radiates mainly to the thighs, calves, ankle joints, and soles, which is highly sensitive, with pain that seems to be stabbing, dull, burning, electrical, numb, or a bug crawling through. Many treatments have been presented to mitigate these radiations, mainly spinal therapy, physical therapy, massage, and a variety of drugs, including anti-inflammatory drugs, muscle relaxants, as well as the use of gabapentin and pregarine among these various drugs. In recent years, out-of-peritoneal injection therapy and neuromuscular blocking have been commonly performed as minimally invasive treatments. Among these, neuromuscular blocking is a method of relieving pain by injecting adrenal cortical hormones and local anesthetic agents into the compressed nerve muscles that cause radiation. Although there are differences over the ultimate treatment effectiveness of neuromuscular blocking, the prevailing view is that it is an effective treatment method, according to several researchers. Pedestrian disorder (parachute) is also a typical symptom caused by blood flow disorders in paralyzed areas, and various drugs, especially Limaprost, are mainly used as treatment agents.
    <Purpose>
    For spinal stenosis patients prescribed for neuromuscular blocking and limaprost, pregabalin, etc, acupuncture, cupping and manual therapy will be conducted three times a week for four weeks to evaluate the effectiveness of pain improvement, health condition change, and safety of comprehensive and integrative medical treatment.
    <The Method>
    For spinal stenosis patients who complains of radiating pain (LANSS > 7), who needs selective nerve root block with VAS of 3 or more, patients are devided two groups. The experimental group will be treated acupuncture, cupping and manual therapy and control group will be provided conventionl treatment excepting acupuncture, cupping and manual therapy. We would like to evaluate and compare short-term treatment (two weeks after treatment) with intermediate-term treatment effect (six weeks after treatment, 12 weeks after treatment).
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others (comprehensive and integrative medcine)
    Intervention Description
    The experimental group will be prescribed Limaprost, pregabalin and nerve root block, additionally acupuncture and cupping, and conduct a total of 12 massage three times a week for four weeks.
    On the other hand, the control group is prescribed Limaprost, pregabalin and performs nerve root block.
    The acupuncture treatment is performed three times a week for four weeks. The acupoints used in this study are BL23, BL24, BL25, BL26, GB30, GB31, BL40, KI3, BL60. Single use, disposable sterilized needle(stainless steel, 0.25*40mm, 0.30*60mm) will be used. The insertion depth is 10-50mm depending on the location of acupoints, and last for 25±5 minutes.
    Electrical stimulation at a frequency of 4Hz will be applied at BL23, BL25, GB30, GB31.
    
    The cupping method is to take baesuhyeol(배수혈) and maintain negative pressure for five minutes using an electric device.
    A total of 12 massage sessions will be conducted three times a week for four weeks. The therapist reduces pain caused by stenosis and seeks functional recovery of muscles and joints by applying fascia relaxation and massage or appropriate stretching treatment to induce relaxation of the surrounding muscles and ligament joints.
    Number of Arms 2
    Arm 1

    Arm Label

    comprehensive and integrative medicine group

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    The experimental group will be prescribed Limaprost, pregabalin and nerve root block, additionally acupuncture and cupping, and conduct a total of 12 massage three times a week for four weeks.
    Arm 2

    Arm Label

    control group

    Target Number of Participant

    15

    Arm Type

    Active comparator

    Arm Description

    the control group is prescribed Limaprost, pregabalin and performs nerve root block.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M48.06)Spinal stenosis, lumbar region 

    Patients diagnosed with lumbar spinal stenosis who complain of radial pain (LANSS 7 7) and require selective nerve root blockwith VAS 3 or more points.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~80Year

    Description

    1. under the age of 80
    2. Patient diagnosed with lumbar spinal stenosis with symptoms and complaining of lower limb radial pain (LANSS > 7)
    3. Patients requiring selective neuromuscular blockage with a degree of VAS 3 or higher
    4. Patients who voluntarily consents to a written consent form.
    Exclusion Criteria
    1. under the age of 20
    2. Patients who are pregnant 
    3. Patients with secondary benefits (industrial accidents, auto insurance, etc.)
    4. patients with severe comorbidity
    5. Patients who are unable to administrate drugs.
    6. Patients who were involved in an interventional study during the period of study
    7. patients who suffer from a cancer-related pain caused by primary or metastatic cancer in the spine.
    8. Patients who cannot communicate, such as questionnaires, etc.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    VAS(Visual Analog Sacale)
    Timepoint
    after each treatment
    Secondary Outcome(s) 1
    Outcome
    SF-36 (Health Survey for Spine Patients)
    Timepoint
    Two weeks before treatment, six weeks after treatment, 12 weeks after treatment.
    Secondary Outcome(s) 2
    Outcome
    RMDQ (Revised Roland Disability Scale)
    Timepoint
    Two weeks before treatment, six weeks after treatment, 12 weeks after treatment.
    Secondary Outcome(s) 3
    Outcome
    ODI (Oswestry Disability Index)
    Timepoint
    Two weeks before treatment, six weeks after treatment, 12 weeks after treatment.
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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