The Effect of Integrated CAM Treatment in Hospitalized Patients

NCT02257723 | Recruiting DMC

• 1 other identifier: JS-CT-2012-03
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Neck Pain; Knee Pain; Shoulder Pain; Intervertebral Disc Herniation; Spinal Stenosis

Keywords

Inpatient care; Complementary and alternative medicine; Integrated medicine

Outcome Measures

Primary Outcomes (10)

• NRS of low back pain (LBP)

  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.

  Admission (baseline), 2 weeks, Discharge

• NRS of radiating leg pain

  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.

  Admission (baseline), 2 weeks, Discharge

• NRS of neck pain

  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.

  Admission (baseline), 2 weeks, Discharge

• NRS of radiating arm pain

  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.

  Admission (baseline), 2 weeks, Discharge

• NRS of knee pain

  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.

  Admission (baseline), 2 weeks, Discharge

• NRS of shoulder pain

  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.

  Admission (baseline), 2 weeks, Discharge

• Oswestry disability index (ODI)

  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.

  Admission (baseline), 2 weeks, Discharge

• Vernon-Mior Neck Disability Index (NDI)

  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.

  Admission (baseline), 2 weeks, Discharge

• The Korean Western Ontario McMaster Index

  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.

  Admission (baseline), 2 weeks, Discharge

• Shoulder Pain and Disability Index

  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.

  Admission (baseline), 2 weeks, Discharge

Secondary Outcomes (1)

• Physical and neurological examinations

  Admission (baseline), 2 weeks, Discharge

Other Outcomes (1)

• Other baseline variables

  Admission (baseline)

Interventions

Herbal medicine DRUG

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).

Also known as: Traditional herbal medicine

Acupuncture PROCEDURE

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

Pharmacopuncture PROCEDURE

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).

Bee venom pharmacopuncture PROCEDURE

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).

Chuna manipulation PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients hospitalized due to spine or joint diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 06110, South Korea

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Shoulder Pain; Intervertebral Disc Displacement; Spinal Stenosis

Interventions

Phytotherapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• In-Hyuk Ha, PhD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

In-Hyuk Ha, PhD

CONTACT

+82 2 2222 2740; hanihata@gmail.com

Me-riong Kim, Master

CONTACT

+82 2 2222 2746; krmkmr@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: January 1, 2012
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2040
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

KR (1)