The Effect of Integrated CAM Treatment in Hospitalized Patients

Recruiting

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

• Registration Number: NCT02257723
• Lead Sponsor: Jaseng Hospital of Korean Medicine

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.

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2030-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NRS of neck pain	Admission (baseline), 2 weeks, Discharge	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.
NRS of radiating leg pain	Admission (baseline), 2 weeks, Discharge	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.
NRS of knee pain	Admission (baseline), 2 weeks, Discharge	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.
NRS of low back pain (LBP)	Admission (baseline), 2 weeks, Discharge	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.
NRS of radiating arm pain	Admission (baseline), 2 weeks, Discharge	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.
The Korean Western Ontario McMaster Index	Admission (baseline), 2 weeks, Discharge	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.
NRS of shoulder pain	Admission (baseline), 2 weeks, Discharge	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.
Oswestry disability index (ODI)	Admission (baseline), 2 weeks, Discharge	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.
Vernon-Mior Neck Disability Index (NDI)	Admission (baseline), 2 weeks, Discharge	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.
Shoulder Pain and Disability Index	Admission (baseline), 2 weeks, Discharge	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.

Secondary Outcome Measures

Name	Time	Method
Physical and neurological examinations	Admission (baseline), 2 weeks, Discharge	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.

Trial Locations

Locations (1)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of