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NCT Number: 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

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.

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Key information

Conditions

OPLL Medicine, Korean Traditional

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Seoul, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phone survey

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 24, 2020
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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