Clinical trial NCT04855058: Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study
Official title: Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Medicine, Korean Traditional
Keywords: acupuncture therapy
herbal medicine
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 665
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Numeric rating scale(NRS) to longterm f/u survey
timeFrame: 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 outcomes:
measure: The five level version of EuroQol-5 Dimension (EQ-5D)
timeFrame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
measure: Oswestry disability index (ODI)
timeFrame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
measure: Neck Disability Index (NDI)
timeFrame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
measure: Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH)
timeFrame: at finish f/u survey by June 2021
measure: the Hip Disability and Osteoarthritis Outcome Score(HOOS)
timeFrame: at finish f/u survey by June 2021
measure: the Foot Function Index (FFI)
timeFrame: at finish f/u survey by June 2021
measure: Symptoms of RIB,STERNUM fracture
timeFrame: at finish f/u survey by June 2021
measure: Patient Global Impression of Change (PGIC)
timeFrame: at finish f/u survey by June 2021
measure: hanbangchilyo manjogdo (Satisfaction with integrative Korean medicine)
timeFrame: at finish f/u survey by June 2021
Other outcomes:
Locations:
city: Seoul-si
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
References: