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

Sponsor

Jaseng Medical Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT04446221

Collaborator

(none)

Enrollment

Location

18.6

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
OPLL Medicine, Korean Traditional	Other: phone survey

Study Design

Study Type:

Observational

Actual Enrollment :

78 participants

Observational Model:

Other

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jun 12, 2020

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Numeric rating scale (NRS) [Finish survey by September 2020]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jaseng Medical Foundation	Seoul		Korea, Republic of

Sponsors and Collaborators

Jaseng Medical Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation

ClinicalTrials.gov Identifier:

NCT04446221

Other Study ID Numbers:

JS-CT-2020-05

First Posted:

Jun 24, 2020

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation

acupuncture therapy

herbal medicine

Additional relevant MeSH terms:

Ossification of Posterior Longitudinal Ligament

Neck Pain

Study Results

No Results Posted as of Feb 8, 2022