Clinical trial NCT04446221: Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study
Official title: Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OPLL
Medicine, Korean Traditional
Keywords: acupuncture therapy
herbal medicine
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: Finish survey by September 2020
Secondary outcomes:
measure: Vernon-Mior Neck Disability Index (NDI)
timeFrame: Finish survey by September 2020
measure: The five level version of EuroQol-5 Dimension (EQ-5D)
timeFrame: Finish survey by September 2020
measure: Patient Global Impression of Change (PGIC)
timeFrame: Finish survey by September 2020
measure: Spine surgery
timeFrame: Finish survey by September 2020
measure: Current symptoms survey
timeFrame: Finish survey by September 2020
measure: Treatment after discharge survey
timeFrame: Finish survey by September 2020
measure: Satisfaction with integrative Korean medicine survey
timeFrame: Finish survey by September 2020
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
References: