Cervical MyelopathyNCT04173923
Long Term Follow-up of Cervical Myelopathy Inpatients Treated With Integrated Complementary and Alternative Medicine
An observational study of Cervical Myelopathy, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
Model of this study is a combined both retrospective chart review and follow up survey. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in cervical myelopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- Herbal medicine, Chuna manual medicine and Pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2018to 19 Nov 2020
- How long will I take part?
- 8 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who ended up the hospitalization and treatment in Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, Incheon Jaseng Korean Medicine Hospital
Who may be able to join
- Patients who had been hospitalized with symptoms of neurological defects such as muscle weakness in the upper extremity or sensory abnormalities, or impaired walking due to weakness in the lower extremity at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Incheon Jaseng Korean Medicine Hospital from Jan 2011 to Oct 2018.
- Patients diagnosed with 'Cervical myelopathy' finding and able to check the pressure and damage of the spinal cord (high signal shading) of the EMR imaging (T2-weighted MRI scan of C-spine)
- Patients who agreed voluntarily to participate in verbal consent
Who cannot join
- Patients whose chief complaint is not cervical myelopathy or who do not have the neurological defect of upper extremity or lower extremity
- If the cause of the neurological defect of the upper and lower extremities is not caused by the spine or tissue
- Patients who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Haeundae Jaseng Hospital of Korean Medicine
Busan, 48102
About this study
Model of this study is a combined both retrospective chart review and follow up survey. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in cervical myelopathy.
Read the detailed description
Cervical myelopathy is known as Its symptoms are progressively worsened, and there are only a small amount of positive outcomes other than surgery.
However, as with other spinal and nerve disorders, non-surgical treatments are getting more attention in terms of patient safety, and because they provide patients with more choice in treatment than in terms of surgical treatment, they can provide closer approach to patient-centered care.
Physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of cervical myelopathy by using Korean medicine treatment so far has its weak level. Therefore, it is expected that this study will demonstrate the efficacy of the treatment of cervical myelopathy in Korean medicine treatment and will further pave the way for non-surgical treatment of spinal myelopathy.
Therefore, The investigators conducted observational trial to analyze the effectiveness of Korean medicine treatment in spinal myelopathy. Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data.
The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. The questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.
- Conditions
- Cervical Myelopathy
- Being tested
- Herbal medicine, Chuna manual medicine, Pharmacopuncture, Acupuncture, Electroacupuncture
- Keywords
- Cervical Myelopathy, Korean medicine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicineDrug
Also called Traditional herbal medicine
Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.
Chuna manual medicineProcedure or surgery
Also called Chuna manipulation
Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint 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. Chuna manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
PharmacopunctureProcedure or surgery
Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.
AcupunctureProcedure or surgery
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
ElectroacupunctureProcedure or surgery
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
CuppingProcedure or surgery
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)Procedure or surgery
Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical spinal surgery status after discharge
The investigators will survey whether the patients had surgery after discharging from 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital.
Measured: Finish survey by Jan 2020
Secondary outcomes (8)
Cervical spinal surgery recommendations before hospitalization
The investigators will survey whether the patients were recommended before hospitalization in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital).
Measured: Finish survey by Jan 2020
Symptom reoccurrence experience lasting for more than a month after treatment is closed
The investigators will survey whether the patients experienced symptom reoccurrence lasting for more than a month after treatment is closed after hospitalization in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital).
Measured: Finish survey by Jan 2020
Whether symptoms that are uncomfortable in daily life exists
The investigators will survey whether the patients feel uncomfortable daily life symptoms after hospitalization in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital).
Measured: Finish survey by Jan 2020
Whether currently being treated for neck or upper extremity symptoms
The investigators will survey whether the patients are currently being treated for neck or upper extremity symptoms
Measured: Finish survey by Jan 2020
Numeric Rating Scale of Neck and upper extremity pain
The investigators will survey Numeric Rating Scale(NRS) scores of neck and upper extremity at the time of the disease and current symptoms.
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: Finish survey by Jan 2020
Neck Disability Index
The investigators will survey current Neck Disability Index (NDI) scores. NDI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
Measured: Finish survey by Jan 2020
EuroQol 5-dimensions 5-levels
The investigators will survey current EuroQol 5-dimensions 5-levels scores. The EQ-5D-5L is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems).
Measured: Finish survey by Jan 2020
Patient Global Impression of Change
The investigators will survey current Patient Global Impression of Change scores.
The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.
Measured: Finish survey by Jan 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start20 Nov 2018
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies 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
- Other
- Enrolment
- 40 participants (actual)
- Target duration
- 8 Months
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
- Investigators
- In-Hyuk Ha, Study chair, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173923
- Sponsor's protocol ID
- JS-CT-2019-05
- Status last verified
- Aug 2022
- First submitted
- 21 Nov 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Cervical Myelopathy Inpatients Treated With Integrated Complementary and Alternative Medicine
- ClinicalTrials.gov ID
- NCT04173923
- Acronym / sponsor ID
- JS-CT-2019-05
- Conditions
- Cervical Myelopathy
- Keywords
- Cervical Myelopathy, Korean medicine treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 22 Nov 2019 (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.
Model of this study is a combined both retrospective chart review and follow up survey. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in cervical myelopathy.
Detailed description
Cervical myelopathy is known as Its symptoms are progressively worsened, and there are only a small amount of positive outcomes other than surgery.
However, as with other spinal and nerve disorders, non-surgical treatments are getting more attention in terms of patient safety, and because they provide patients with more choice in treatment than in terms of surgical treatment, they can provide closer approach to patient-centered care.
Physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of cervical myelopathy by using Korean medicine treatment so far has its weak level. Therefore, it is expected that this study will demonstrate the efficacy of the treatment of cervical myelopathy in Korean medicine treatment and will further pave the way for non-surgical treatment of spinal myelopathy.
Therefore, The investigators conducted observational trial to analyze the effectiveness of Korean medicine treatment in spinal myelopathy. Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data.
The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. The questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 8 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who ended up the hospitalization and treatment in Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, Incheon Jaseng Korean Medicine Hospital
Key inclusion criteria (3 listed)
- Patients who had been hospitalized with symptoms of neurological defects such as muscle weakness in the upper extremity or sensory abnormalities, or impaired walking due to weakness in the lower extremity at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Incheon Jaseng Korean Medicine Hospital from Jan 2011 to Oct 2018.
- Patients diagnosed with 'Cervical myelopathy' finding and able to check the pressure and damage of the spinal cord (high signal shading) of the EMR imaging (T2-weighted MRI scan of C-spine)
- Patients who agreed voluntarily to participate in verbal consent
Key exclusion criteria (3 listed)
- Patients whose chief complaint is not cervical myelopathy or who do not have the neurological defect of upper extremity or lower extremity
- If the cause of the neurological defect of the upper and lower extremities is not caused by the spine or tissue
- Patients who do not agree to participate in the study
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 |
|---|---|---|
| Herbal medicineAlso: Traditional herbal medicineHerbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion. | Drug | – |
| Chuna manual medicineAlso: Chuna manipulationChuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint 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. Chuna manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion. | Procedure or surgery | – |
| PharmacopuncturePharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion. | Procedure or surgery | – |
| AcupunctureAcupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| ElectroacupunctureElectroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| CuppingCupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| Other intervention(s)Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study. | Procedure or surgery | – |
Primary outcome
Cervical spinal surgery status after discharge
Time frame: Finish survey by Jan 2020
The investigators will survey whether the patients had surgery after discharging from 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Incheon Jaseng Korean Medicine Hospital.
8 secondary outcomes
Cervical spinal surgery recommendations before hospitalization
Time frame: Finish survey by Jan 2020
Symptom reoccurrence experience lasting for more than a month after treatment is closed
Time frame: Finish survey by Jan 2020
Whether symptoms that are uncomfortable in daily life exists
Time frame: Finish survey by Jan 2020
Whether currently being treated for neck or upper extremity symptoms
Time frame: Finish survey by Jan 2020
Numeric Rating Scale of Neck and upper extremity pain
Time frame: Finish survey by Jan 2020
Neck Disability Index
Time frame: Finish survey by Jan 2020
EuroQol 5-dimensions 5-levels
Time frame: Finish survey by Jan 2020
Patient Global Impression of Change
Time frame: Finish survey by Jan 2020
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 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
In-Hyuk Ha study chair
Jaseng Medical Foundation
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 Cervical Myelopathy, 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 3 inclusion and 3 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 10 Aug 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?
Cervical spinal surgery status after discharge (time frame: Finish survey by Jan 2020). 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 10 Aug 2022.