The Effect of Integrated CAM Treatment in Hospitalized Patients

NCT ID: NCT02257723

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2040-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DRUG

Acupuncture

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

Intervention Type 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).

Intervention Type 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).

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Traditional herbal medicine

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Hospital of Korean Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In-Hyuk Ha, PhD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

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Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In-Hyuk Ha, PhD

Role: CONTACT

+82 2 2222 2740

Me-riong Kim, Master

Role: CONTACT

+82 2 2222 2746

Facility Contacts

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In-Hyuk Ha, PhD

Role: primary

+82-2-2222-2740

References

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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.

Reference Type DERIVED
PMID: 28928789 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26850111 (View on PubMed)

Other Identifiers

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JS-CT-2012-03

Identifier Type: -

Identifier Source: org_study_id

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