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The Effect of Integrated CAM Treatment in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT02257723
Recruitment Status : Recruiting
First Posted : October 6, 2014
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Jaseng Hospital of Korean Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Low Back Pain Neck Pain Knee Pain Shoulder Pain Intervertebral Disc Herniation Spinal Stenosis Drug: Herbal medicine Procedure: Acupuncture Procedure: Pharmacopuncture Procedure: Bee venom pharmacopuncture Procedure: Chuna manipulation

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital
Actual Study Start Date : January 2012
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2040

Intervention Details:
  • Drug: Herbal medicine
    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
  • Procedure: Acupuncture
    Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
  • Procedure: Pharmacopuncture
    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).
  • Procedure: Bee venom pharmacopuncture
    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).
  • Procedure: Chuna manipulation
    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.


Primary Outcome Measures :
  1. NRS of low back pain (LBP) [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  2. NRS of radiating leg pain [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  3. NRS of neck pain [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  4. NRS of radiating arm pain [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  5. NRS of knee pain [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  6. NRS of shoulder pain [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  7. Oswestry disability index (ODI) [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  8. Vernon-Mior Neck Disability Index (NDI) [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.

  9. The Korean Western Ontario McMaster Index [ Time Frame: Admission (baseline), 2 weeks, Discharge ]

    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.


  10. Shoulder Pain and Disability Index [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.


Secondary Outcome Measures :
  1. Physical and neurological examinations [ Time Frame: Admission (baseline), 2 weeks, Discharge ]
    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.


Other Outcome Measures:
  1. Other baseline variables [ Time Frame: Admission (baseline) ]
    The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.
Criteria

Inclusion Criteria:

  • Patients hospitalized due to spine or joint diseases

Exclusion Criteria:

  • Main complaint other than back pain, radiating leg pain, neck pain, radiating arm pain, knee pain or shoulder pain
  • Cause of pain non-related to spine, joint or soft tissue; for example, spinal tumors, pregnancy, urolithiasis, etc.
  • Refusal to provide the information needed for clinical research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257723


Contacts
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Contact: In-Hyuk Ha, PhD +82 2 2222 2740 hanihata@gmail.com
Contact: Me-riong Kim, Master +82 2 2222 2746 krmkmr@naver.com

Locations
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Korea, Republic of
Jaseng Hospital of Korean Medicine Recruiting
Seoul, Gangnam-Gu, Korea, Republic of, 06110
Contact: In-Hyuk Ha, PhD    +82-2-2222-2740    hanihata@gmail.com   
Sponsors and Collaborators
Jaseng Hospital of Korean Medicine
Investigators
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Principal Investigator: In-Hyuk Ha, PhD Jaseng Medical Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier: NCT02257723    
Other Study ID Numbers: JS-CT-2012-03
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Keywords provided by Jaseng Hospital of Korean Medicine:
Inpatient care
Complementary and alternative medicine
Integrated medicine
Additional relevant MeSH terms:
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Shoulder Pain
Spinal Stenosis
Low Back Pain
Neck Pain
Back Pain
Pain
Neurologic Manifestations
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases