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

NCT04446221 | Completed

• 1 other identifier: JS-CT-2020-05
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

OPLL; Medicine, Korean Traditional

Keywords

acupuncture therapy; herbal medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Vernon-Mior Neck Disability Index (NDI)

  Finish survey by September 2020

• The five level version of EuroQol-5 Dimension (EQ-5D)

  Finish survey by September 2020

• Patient Global Impression of Change (PGIC)

  Finish survey by September 2020

• Spine surgery

  Finish survey by September 2020

• Current symptoms survey

  Finish survey by September 2020

Interventions

phone survey OTHER

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: June 12, 2020
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)