The Effect of Integrated CAM Treatment in Hospitalized Patients

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02257723
• Other study ID #: JS-CT-2012-03
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2040

Study information

• Verified date: September 2023
• Source: Jaseng Hospital of Korean Medicine
• Contact: In-Hyuk Ha, PhD
• Phone: +82 2 2222 2740
• Email: hanihata[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 2040
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other baseline variables	The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking	Admission (baseline)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Physical and neurological examinations	The range of flexion and extension was assessed to objectively measure mobility, and straight leg raising (SLR), sensory function, muscle strength, and deep tendon reflex tests were conducted for neurological assessment.	Admission (baseline), 2 weeks, Discharge