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

Medicine, Korean Traditional Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446221
• Other study ID #: JS-CT-2020-05
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Medicine, Korean Traditional
• Neck Pain
• OPLL
• Ossification of Posterior Longitudinal Ligament

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Medical Foundation	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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