<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02257723</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2012-03</org_study_id>
    <nct_id>NCT02257723</nct_id>
  </id_info>
  <brief_title>The Effect of Integrated CAM Treatment in Hospitalized Patients</brief_title>
  <official_title>The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Hospital of Korean Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jaseng Hospital of Korean Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effect of hospital-based intensive non-surgical treatment in&#xD;
      musculoskeletal patients admitted to an integrated hospital that offers both complementary&#xD;
      and alternative medicine (CAM) and conventional medicine treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study investigates the effect of hospital-based intensive non-surgical treatment in&#xD;
      musculoskeletal patients admitted to an integrated hospital that offers both complementary&#xD;
      and alternative medicine (CAM) and conventional medicine treatment.&#xD;
&#xD;
      Inpatients received treatment according to a CAM treatment protocol (herbal medicine,&#xD;
      acupuncture, bee venom pharmacopuncture, and Chuna manipulation) and conventional medicine&#xD;
      treatment as needed. The main outcome measures were the duration of pain, NRS of back pain,&#xD;
      radiating leg pain, neck pain, radiating arm pain, knee pain, shoulder pain, previous&#xD;
      surgery, previous interventions (injections), Oswestry Disability Index (ODI), Vernon-Mior&#xD;
      Neck Disability Index, the Korean Western Ontario McMaster Index, Shoulder Pain and&#xD;
      Disability Index, range of motion (ROM), Straight leg raise test (SLR), alcohol use, smoking&#xD;
      at admission, 2 weeks, and discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Anticipated">December 2040</completion_date>
  <primary_completion_date type="Anticipated">December 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NRS of low back pain (LBP)</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The patients were asked to quantify their current LBP, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS of radiating leg pain</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The patients were asked to quantify their current leg pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS of neck pain</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The patients were asked to quantify their current neck pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS of radiating arm pain</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The patients were asked to quantify their current radiating arm pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS of knee pain</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The patients were asked to quantify their current knee pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NRS of shoulder pain</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The patients were asked to quantify their current shoulder pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry disability index (ODI)</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The ODI is a survey assessing the patients' degree of functional disability in daily life consisting of 10 questions with 6 choices each corresponding to 0-5 points. The scores for each item are added, divided by 50, then multiplied by 100 to calculate the degree of disability. The Korean version of the ODI of which the reliability and validity have been verified through the research of Jeon et al. was used in this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vernon-Mior Neck Disability Index (NDI)</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>NDI is a survey for evaluating disabilities that can be caused by neck pain in daily life performance. It consists of a total of 50 points by selecting a number from 0 to 5 for each item in 10 questions. The higher the score, the greater the daily disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Korean Western Ontario McMaster Index</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>WOMAC is one of the most widely used indicators of the overall joint function score of the knee joint. A tool for evaluating disorders related to osteoarthritis of the lower extremities, including joints or knee joints.&#xD;
WOMAC consists of a total of 24 questions and three subscales. It consists of 5 questions about pain, 2 questions about stiffness, and 17 questions about difficulty in performing daily life related to the rest of the physical functions, so it is designed to measure the overall functional state of the joint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical and neurological examinations</measure>
    <time_frame>Admission (baseline), 2 weeks, Discharge</time_frame>
    <description>The range of flexion and extension was assessed to objectively measure mobility, and straight leg raising (SLR), sensory function, muscle strength, and deep tendon reflex tests were conducted for neurological assessment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other baseline variables</measure>
    <time_frame>Admission (baseline)</time_frame>
    <description>The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking</description>
  </other_outcome>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Neck Pain</condition>
  <condition>Knee Pain</condition>
  <condition>Shoulder Pain</condition>
  <condition>Intervertebral Disc Herniation</condition>
  <condition>Spinal Stenosis</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Herbal medicine</intervention_name>
    <description>Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).</description>
    <other_name>Traditional herbal medicine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pharmacopuncture</intervention_name>
    <description>Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bee venom pharmacopuncture</intervention_name>
    <description>Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chuna manipulation</intervention_name>
    <description>Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Musculoskeletal patients admitted to an integrated hospital that offers both complementary&#xD;
        and alternative medicine (CAM) and conventional medicine treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized due to spine or joint diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Main complaint other than back pain, radiating leg pain, neck pain, radiating arm&#xD;
             pain, knee pain or shoulder pain&#xD;
&#xD;
          -  Cause of pain non-related to spine, joint or soft tissue; for example, spinal tumors,&#xD;
             pregnancy, urolithiasis, etc.&#xD;
&#xD;
          -  Refusal to provide the information needed for clinical research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Hyuk Ha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Medical Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>In-Hyuk Ha, PhD</last_name>
    <phone>+82 2 2222 2740</phone>
    <email>hanihata@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Me-riong Kim, Master</last_name>
    <phone>+82 2 2222 2746</phone>
    <email>krmkmr@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-Gu</state>
        <zip>06110</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>In-Hyuk Ha, PhD</last_name>
      <phone>+82-2-2222-2740</phone>
      <email>hanihata@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inpatient care</keyword>
  <keyword>Complementary and alternative medicine</keyword>
  <keyword>Integrated medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257723
org study id: JS-CT-2012-03
nct id: NCT02257723
lead sponsor: 
has dmc: Yes
This study investigates the effect of hospital-based intensive non-surgical treatment in
      musculoskeletal patients admitted to an integrated hospital that offers both complementary
      and alternative medicine (CAM) and conventional medicine treatment.
This study investigates the effect of hospital-based intensive non-surgical treatment in
      musculoskeletal patients admitted to an integrated hospital that offers both complementary
      and alternative medicine (CAM) and conventional medicine treatment.

      Inpatients received treatment according to a CAM treatment protocol (herbal medicine,
      acupuncture, bee venom pharmacopuncture, and Chuna manipulation) and conventional medicine
      treatment as needed. The main outcome measures were the duration of pain, NRS of back pain,
      radiating leg pain, neck pain, radiating arm pain, knee pain, shoulder pain, previous
      surgery, previous interventions (injections), Oswestry Disability Index (ODI), Vernon-Mior
      Neck Disability Index, the Korean Western Ontario McMaster Index, Shoulder Pain and
      Disability Index, range of motion (ROM), Straight leg raise test (SLR), alcohol use, smoking
      at admission, 2 weeks, and discharge.
observational model: Cohort
time perspective: Prospective
measure: NRS of low back pain (LBP)
time frame: Admission (baseline), 2 weeks, Discharge
description: The patients were asked to quantify their current LBP, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
measure: NRS of radiating leg pain
time frame: Admission (baseline), 2 weeks, Discharge
description: The patients were asked to quantify their current leg pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
measure: NRS of neck pain
time frame: Admission (baseline), 2 weeks, Discharge
description: The patients were asked to quantify their current neck pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
measure: NRS of radiating arm pain
time frame: Admission (baseline), 2 weeks, Discharge
description: The patients were asked to quantify their current radiating arm pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
measure: NRS of knee pain
time frame: Admission (baseline), 2 weeks, Discharge
description: The patients were asked to quantify their current knee pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
measure: NRS of shoulder pain
time frame: Admission (baseline), 2 weeks, Discharge
description: The patients were asked to quantify their current shoulder pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
measure: Oswestry disability index (ODI)
time frame: Admission (baseline), 2 weeks, Discharge
description: The ODI is a survey assessing the patients' degree of functional disability in daily life consisting of 10 questions with 6 choices each corresponding to 0-5 points. The scores for each item are added, divided by 50, then multiplied by 100 to calculate the degree of disability. The Korean version of the ODI of which the reliability and validity have been verified through the research of Jeon et al. was used in this study.
measure: Vernon-Mior Neck Disability Index (NDI)
time frame: Admission (baseline), 2 weeks, Discharge
description: NDI is a survey for evaluating disabilities that can be caused by neck pain in daily life performance. It consists of a total of 50 points by selecting a number from 0 to 5 for each item in 10 questions. The higher the score, the greater the daily disability.
measure: The Korean Western Ontario McMaster Index
time frame: Admission (baseline), 2 weeks, Discharge
description: WOMAC is one of the most widely used indicators of the overall joint function score of the knee joint. A tool for evaluating disorders related to osteoarthritis of the lower extremities, including joints or knee joints.
WOMAC consists of a total of 24 questions and three subscales. It consists of 5 questions about pain, 2 questions about stiffness, and 17 questions about difficulty in performing daily life related to the rest of the physical functions, so it is designed to measure the overall functional state of the joint.
measure: Shoulder Pain and Disability Index
time frame: Admission (baseline), 2 weeks, Discharge
description: SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
measure: Physical and neurological examinations
time frame: Admission (baseline), 2 weeks, Discharge
description: The range of flexion and extension was assessed to objectively measure mobility, and straight leg raising (SLR), sensory function, muscle strength, and deep tendon reflex tests were conducted for neurological assessment.
measure: Other baseline variables
time frame: Admission (baseline)
description: The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking
intervention type: Drug
intervention name: Herbal medicine
description: Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).
other name: Traditional herbal medicine
intervention type: Procedure
intervention name: Acupuncture
description: Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
intervention type: Procedure
intervention name: Pharmacopuncture
description: Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
intervention type: Procedure
intervention name: Bee venom pharmacopuncture
description: Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
intervention type: Procedure
intervention name: Chuna manipulation
description: Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: In-Hyuk Ha, PhD
role: Principal Investigator
affiliation: Jaseng Medical Foundation
last name: In-Hyuk Ha, PhD
phone: +82 2 2222 2740
email: hanihata@gmail.com
last name: Me-riong Kim, Master
phone: +82 2 2222 2746
email: krmkmr@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Displacement
mesh term: Low Back Pain
mesh term: Neck Pain