Clinical trial NCT02257723: The Effect of Integrated CAM Treatment in Hospitalized Patients
Official title: The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Neck Pain
Knee Pain
Shoulder Pain
Intervertebral Disc Herniation
Spinal Stenosis
Keywords: Inpatient care
Complementary and alternative medicine
Integrated medicine
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: NRS of low back pain (LBP)
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: NRS of radiating leg pain
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: NRS of neck pain
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: NRS of radiating arm pain
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: NRS of knee pain
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: NRS of shoulder pain
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: Oswestry disability index (ODI)
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: Vernon-Mior Neck Disability Index (NDI)
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: The Korean Western Ontario McMaster Index
timeFrame: Admission (baseline), 2 weeks, Discharge
measure: Shoulder Pain and Disability Index
timeFrame: Admission (baseline), 2 weeks, Discharge
Secondary outcomes:
measure: Physical and neurological examinations
timeFrame: Admission (baseline), 2 weeks, Discharge
Other outcomes:
measure: Other baseline variables
timeFrame: Admission (baseline)
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MH, Lee YJ, Shin JS, Lee J, Jeong H, Kim MR, Park SM, Go U, Kim SM, Kim JY, Hwang DG, Ha IH. The Long-Term Course of Outcomes for Lumbar Intervertebral Disc Herniation following Integrated Complementary and Alternative Medicine Inpatient Treatment: A Prospective Observational Study. Evid Based Complement Alternat Med. 2017;2017:5239719. doi: 10.1155/2017/5239719. Epub 2017 Aug 27.
citation: Baek SH, Oh JW, Shin JS, Lee J, Lee YJ, Kim MR, Ahn YJ, Choi A, Park KB, Shin BC, Lee MS, Ha IH. Long term follow-up of cervical intervertebral disc herniation inpatients treated with integrated complementary and alternative medicine: a prospective case series observational study. BMC Complement Altern Med. 2016 Feb 4;16:52. doi: 10.1186/s12906-016-1034-z.