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

Overview

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.

Interventions

• 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).
• 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 onc
• 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

• NRS of low back pain (LBP) [Time frame: Admission (baseline), 2 weeks, Discharge]
• NRS of radiating leg pain [Time frame: Admission (baseline), 2 weeks, Discharge]
• NRS of neck pain [Time frame: Admission (baseline), 2 weeks, Discharge]
• NRS of radiating arm pain [Time frame: Admission (baseline), 2 weeks, Discharge]
• NRS of knee pain [Time frame: Admission (baseline), 2 weeks, Discharge]
• NRS of shoulder pain [Time frame: Admission (baseline), 2 weeks, Discharge]
• Oswestry disability index (ODI) [Time frame: Admission (baseline), 2 weeks, Discharge]
• Vernon-Mior Neck Disability Index (NDI) [Time frame: Admission (baseline), 2 weeks, Discharge]
• The Korean Western Ontario McMaster Index [Time frame: Admission (baseline), 2 weeks, Discharge]
• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

South Korea · 1 center

• Jaseng Hospital of Korean Medicine — Seoul

Publications

• 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. PMID 28928789
• 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. PMID 26850111

Identifiers

NCT: NCT02257723 · JS-CT-2012-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗