Long Term Follow-up of Cervical Myelopathy Inpatients Treated With Integrated Complementary and Alternative Medicine

NCT ID: NCT04173923

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2020-11-19

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

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.

Intervention Type: DRUG

Chuna manual medicine

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.

Intervention Type: PROCEDURE

Pharmacopuncture

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.

Intervention Type: PROCEDURE

Acupuncture

Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Intervention Type: PROCEDURE

Electroacupuncture

Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Intervention Type: PROCEDURE

Cupping

Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Traditional herbal medicine; Chuna manipulation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha

Role: STUDY_CHAIR

Jaseng Medical Foundation

Locations

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Countries

South Korea

Other Identifiers

JS-CT-2019-05

Identifier Type: -

Identifier Source: org_study_id