Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04446221|
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
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|
|OPLL Medicine, Korean Traditional||Other: phone survey|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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 :||June 12, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
- Other: phone survey
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
- Numeric rating scale (NRS) [ Time Frame: 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.
- Vernon-Mior Neck Disability Index (NDI) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Finish survey by September 2020 ]The number of spinal surgery after discharge
- Current symptoms survey [ Time Frame: Finish survey by September 2020 ]Pain, neurological problems, etc.
- Treatment after discharge survey [ Time Frame: Finish survey by September 2020 ]Treatment history in the last 3 month
- Satisfaction with integrative Korean medicine survey [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04446221
|Contact: In-Hyuk Ha, Dr.||email@example.com|
|Contact: Jin Namgoongfirstname.lastname@example.org|
|Korea, Republic of|
|Jaseng Medical Foundation||Recruiting|
|Seoul, Korea, Republic of|
|Contact: In-Hyuk Ha, KMD 82-2-3218-2188 email@example.com|