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

NCT04173923 | Completed

• 1 other identifier: JS-CT-2019-05
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Myelopathy

Keywords

Cervical Myelopathy; Korean medicine treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Finish survey by Jan 2020

Secondary Outcomes (8)

• Cervical spinal surgery recommendations before hospitalization

  Finish survey by Jan 2020

• Symptom reoccurrence experience lasting for more than a month after treatment is closed

  Finish survey by Jan 2020

• Whether symptoms that are uncomfortable in daily life exists

  Finish survey by Jan 2020

• Whether currently being treated for neck or upper extremity symptoms

  Finish survey by Jan 2020

• Numeric Rating Scale of Neck and upper extremity pain

  Finish survey by Jan 2020

Interventions

Herbal medicine DRUG

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.

Also known as: Traditional herbal medicine

Chuna manual medicine PROCEDURE

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.

Also known as: Chuna manipulation

Pharmacopuncture PROCEDURE

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.

Acupuncture PROCEDURE

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

Electroacupuncture PROCEDURE

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

Cupping PROCEDURE

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

Other intervention(s) PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

Location

MeSH Terms

Interventions

Phytotherapy; Acupuncture Therapy; Electroacupuncture; Cupping Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• In-Hyuk Ha

  Jaseng Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: November 20, 2018
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

KR (1)