Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, KMD, Jaseng Medical Foundation

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
OPLL Medicine, Korean Traditional Other: phone survey

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. Spine surgery [ Time Frame: Finish survey by September 2020 ]
    The number of spinal surgery after discharge

  5. Current symptoms survey [ Time Frame: Finish survey by September 2020 ]
    Pain, neurological problems, etc.

  6. Treatment after discharge survey [ Time Frame: Finish survey by September 2020 ]
    Treatment history in the last 3 month

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: In-Hyuk Ha, Dr. 82-2-2222-2740 hanihata@gmail.com
Contact: Jin Namgoong 82-2-2222-2740 bomagizmd@naver.com

Locations
Layout table for location information
Korea, Republic of
Jaseng Medical Foundation Recruiting
Seoul, Korea, Republic of
Contact: In-Hyuk Ha, KMD    82-2-3218-2188    hanihata@gmail.com   
Sponsors and Collaborators
Jaseng Medical Foundation
Layout table for additonal information
Responsible Party: In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT04446221    
Other Study ID Numbers: JS-CT-2020-05-OPLL
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by In-Hyuk Ha, KMD, Jaseng Medical Foundation:
acupuncture therapy
herbal medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Ossification of Posterior Longitudinal Ligament
Neck Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Ossification, Heterotopic
Pathologic Processes