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Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study

Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04446221
Enrollment
78
Registered
2020-06-24
Start date
2020-06-12
Completion date
2021-12-31
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medicine, Korean Traditional, OPLL

Keywords

acupuncture therapy, herbal medicine

Brief summary

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Ossification of Posterior Longitudinal Ligament(OPLL) by observation inpatients treated with integrative Korean medicine. This study is a prospective observational study. The subjects for study are patients diagnosed with OPLL and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2019.12.31. Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Vernon-Mior Neck Disability Index (NDI), quality of life, and Patient Global Impression of Change (PGIC), etc.

Interventions

A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.

Sponsors

Jaseng Medical Foundation
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Patients diagnosed with OPLL by C spine X-ray or MRI or CT * Paithents who was admitted to Jaseng hospital of Korean medicien. * Patients have agreed to participate the study.

Exclusion criteria

* Patient hospitalized under 3 days * Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on) * Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, fibromyalgia, rheumatoid arthritis, gout, and so on) * Patients had cervical spinal surgery within 3 months * Patients diagnosed with C spine fracture by C spine X-ray or MRI or CT * Patients deemed unable to participate in the clinical research by other researchers * Patients haven't agreed to participate the study.

Design outcomes

Primary

MeasureTime frameDescription
Numeric rating scale (NRS)Finish survey by September 2020NRS 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'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.

Secondary

MeasureTime frameDescription
The five level version of EuroQol-5 Dimension (EQ-5D)Finish survey by September 2020EQ-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.
Patient Global Impression of Change (PGIC)Finish survey by September 2020PGIC 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).
Spine surgeryFinish survey by September 2020The number of spinal surgery after discharge
Vernon-Mior Neck Disability Index (NDI)Finish survey by September 2020NDI 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
Treatment after discharge surveyFinish survey by September 2020Treatment history in the last 3 month
Satisfaction with integrative Korean medicine surveyFinish survey by September 2020Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.
Current symptoms surveyFinish survey by September 2020Pain, neurological problems, etc.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026