Fractures, BoneNCT04855058
Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study
An observational study of Fractures, Bone and Medicine, Korean Traditional, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Fractures, Bone, Medicine, Korean Traditional
- What is being tested?
- online survey(or phone survey)
- How many people
- 665 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 19-85 years old
- Pateints who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) and hospitalized 5 days or more
- fracture caused by trauma
- Patients have agreed to participate the study.
Who cannot join
- pathological fracture, stress fracture
- Open fracture
- The cause of pain is due to other disease, not the fracture: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
- Patients who are difficult to complete the research questionaire because of communication, mental or physical capabilities.
- lack of data of collection
- Patients deemed unable to participate in the clinical research by other researchers
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Fractures, Bone, Medicine, Korean Traditional
- Being tested
- online survey(or phone survey)
- Keywords
- acupuncture therapy, herbal medicine
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online survey(or phone survey)Other
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over google survey(or the phone survey) for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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 (11)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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
Measured: at finish f/u survey by June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start29 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855058
- Sponsor's protocol ID
- JS-CT-2020-15
- Status last verified
- Jan 2022
- First submitted
- 12 Apr 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study
- ClinicalTrials.gov ID
- NCT04855058
- Acronym / sponsor ID
- JS-CT-2020-15
- Conditions
- Fractures, Bone, Medicine, Korean Traditional
- Keywords
- acupuncture therapy, herbal medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 19-85 years old
- Pateints who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) and hospitalized 5 days or more
- fracture caused by trauma
- Patients have agreed to participate the study.
Key exclusion criteria (6 listed)
- pathological fracture, stress fracture
- Open fracture
- The cause of pain is due to other disease, not the fracture: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
- Patients who are difficult to complete the research questionaire because of communication, mental or physical capabilities.
- lack of data of collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online survey(or phone survey)A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over google survey(or the phone survey) for patients. | Other | – |
Primary outcome
Change from Baseline Numeric rating scale(NRS) to longterm f/u survey
Time frame: baseline(admission), week 1, 2, 3, 4, 5, 6, 7, day of Discharge(up to week 8), finish f/u survey by June 2021
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'.
11 secondary outcomes
The five level version of EuroQol-5 Dimension (EQ-5D)
Time frame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
Oswestry disability index (ODI)
Time frame: baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021
Neck Disability Index (NDI)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: at finish f/u survey by June 2021
the Hip Disability and Osteoarthritis Outcome Score(HOOS)
Time frame: at finish f/u survey by June 2021
the Foot Function Index (FFI)
Time frame: at finish f/u survey by June 2021
Symptoms of RIB,STERNUM fracture
Time frame: at finish f/u survey by June 2021
Patient Global Impression of Change (PGIC)
Time frame: at finish f/u survey by June 2021
hanbangchilyo manjogdo (Satisfaction with integrative Korean medicine)
Time frame: at finish f/u survey by June 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Medicine, Korean Traditional, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Numeric rating scale(NRS) to longterm f/u survey (time frame: baseline(admission), week 1, 2, 3, 4, 5, 6, 7, day of Discharge(up to week 8), finish f/u survey by June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.