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The Effect of Integrated CAM Treatment in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT02257723
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : January 9, 2015
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, exercise at admission, 2 weeks, and discharge.


Study Type : Observational
Actual Enrollment : 2946 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital
Study Start Date : January 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine



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

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. The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking, exercise [ Time Frame: Admission (baseline) ]


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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


Locations
Korea, Republic of
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, Korea, Republic of, 135-896
Sponsors and Collaborators
Jaseng Hospital of Korean Medicine
Investigators
Principal Investigator: Joon-Shik Shin, Ph.D. Jaseng Hospital of Korean Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier: NCT02257723     History of Changes
Other Study ID Numbers: JS-CT-2012-03
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Jaseng Hospital of Korean Medicine:
Inpatient care
Complementary and alternative medicine
Integrated medicine

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neck Pain
Shoulder Pain
Spinal Stenosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases