The Effect of Integrated CAM Treatment in Hospitalized Patients

Официальное название

The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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).
• Процедура Acupuncture
  Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
• Процедура 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
• Процедура 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).
• Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Physical and neurological examinations [Срок оценки: Admission (baseline), 2 weeks, Discharge]

Критерии участия

Критерии включения

• Patients hospitalized due to spine or joint diseases

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Jaseng Hospital of Korean Medicine — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT02257723 · JS-CT-2012-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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