Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study

The purpose of this study is to reveal the effectiveness of integrative Korean medicine for trauma fracture by observation inpatients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08.

Medical records of selected patients will be analyzed, and online google surveys(or telephone) will be conducted for each patient. The survey questions are Numeric rating scale (NRS), quality of life, and Patient Global Impression of Change (PGIC), etc.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Medicine, Korean Traditional
• Intervention / Treatment: Other: online survey(or phone survey)

• Study Type: Observational
• Enrollment (Actual): 665

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul-si, Korea, Republic of
    • Jaseng Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects for study are patients diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08.

Description

Inclusion Criteria:

1. 19-85 years old
2. Pateints who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) and hospitalized 5 days or more
3. fracture caused by trauma
4. Patients have agreed to participate the study.

Exclusion Criteria:

1. pathological fracture, stress fracture
2. Open fracture
3. The cause of pain is due to other disease, not the fracture: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
4. Patients who are difficult to complete the research questionaire because of communication, mental or physical capabilities.
5. lack of data of collection
6. Patients deemed unable to participate in the clinical research by other researchers

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Numeric rating scale(NRS) to longterm f/u survey	NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'.	baseline(admission), week 1, 2, 3, 4, 5, 6, 7, day of Discharge(up to week 8), finish f/u survey by June 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The five level version of EuroQol-5 Dimension (EQ-5D)	EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used	baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
Oswestry disability index (ODI)	The ODI is a 10-item questionnaire developed to evaluate the degree of disability for low back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean ODI questionnaire(to L-SPINE, T-SPINE and sacrum fracture)	baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
Neck Disability Index (NDI)	NDI is a 10-item questionnaire developed to evaluate the degree of disability for neck back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean NDI questionnaire (to C-SPINE fracture)	baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. We will conduct an validated Korean SPADI questionnaire (to shoulder fracture)	baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	WOMAC is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). We will conduct an validated Korean WOMAC questionnaire. (to knee fracture)	baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH)	The DASH, an instrument that evaluates upper ex- tremity disabilities, has advantages for analyzing the overall function of the upper extremity. The 30 items in the questionnaire ask about different upper extremity disabilities in terms of symptoms, physical functions, social functions, and psychological problems. A shorter version of DASH, known as Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH), consists of 11 items from the original DASH. We will conduct an validated Korean Quick DASH questionnaire. (to clavicle, arm and hand fracture)	at finish f/u survey by June 2021
the Hip Disability and Osteoarthritis Outcome Score(HOOS)	HOOS is developed as an instrument to assess the patients' opinion about their hip and associated problems. HOOS consists of 5 subscales; Pain, other Symptoms, Function in dailyliving (ADL). Standardized answer options are given and each question gets a score from 0 to 4. A normalized score(100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile. We will conduct an validated Korean HOOS questionnaire.(to hip joint , ilium, ischium, and pubis fracture)	at finish f/u survey by June 2021
the Foot Function Index (FFI)	The FFI was developed to measure the effect of foot problems on function in terms of pain and disability. The FFI is a self-administered index consisting of 23 items divided into 3 scales(limitation, pain, and disability). Korean FFI questionnaire was validated in only 2 scales(pain, disability), and we use only pain scale of FFI (to ankle and foot fracture).	at finish f/u survey by June 2021
Symptoms of RIB,STERNUM fracture	There is no validated worldwide used questionnaire. so we use 4 questions about symptoms associated with rib and sternum fracture, based on previous article. (pain during deep breathing, coughing, turning over the body, and sleeping)	at finish f/u survey by June 2021
Patient Global Impression of Change (PGIC)	PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).	at finish f/u survey by June 2021
hanbangchilyo manjogdo (Satisfaction with integrative Korean medicine)	5 answer options are given: very satisfied, a little satisfied, moderate, a little dissatisfied, very dissatisfied	at finish f/u survey by June 2021

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2021
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (ACTUAL): April 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: herbal medicine; acupuncture therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: JS-CT-2020-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No