Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.
Study Details
Study Description
Brief Summary
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.
Study Design
Outcome Measures
Primary Outcome Measures
- Numeric rating scale (NRS) [Finish survey by August 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
- Oswestry disability index (ODI) [Finish survey by August 2020]
he ODI is a 10-item questionnaire developed to evaluate the degree of disability for low 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 ODI questionnaire
- The five level version of EuroQol-5 Dimension (EQ-5D) [Finish survey by August 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 August 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 August 2020]
The number of spinal surgery after discharge
- Current symptoms [Finish survey by August 2020]
Possible walking time without pain, neurological claudication
- Treatment after discharge [Finish survey by August 2020]
Treatment history in the last month
- hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine [Finish survey by August 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
Inclusion Criteria:
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Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
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Patients undergone MRI readings of central spinal stenosis
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Patients have no communication problems
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Patients have agreed to participate the study.
Exclusion Criteria:
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Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
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Patient hospitalized for pain caused by a traffic accident
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Patients with serious mental illness
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Patients deemed unable to participate in the clinical research by other researchers
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
- Study Director: In-Hyuk Ha, Dr., Jaseng Medical Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
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- Bodeker G. Lessons on integration from the developing world's experience. BMJ. 2001 Jan 20;322(7279):164-7.
- Delitto A, Piva SR, Moore CG, Welch WC. Surgery Versus Nonsurgical Treatment of Lumbar Spinal Stenosis. Ann Intern Med. 2015 Sep 1;163(5):397-8. doi: 10.7326/L15-5129-4.
- Deyo RA, Mirza SK, Martin BI. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2011 Sep 14;306(10):1088. doi: 10.1001/jama.2011.1300.
- Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. Review.
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- Lee YJ, Shin JS, Lee J, Kim MR, Ahn YJ, Shin YS, Park KB, Shin BC, Lee MS, Kim JH, Cho JH, Ha IH. Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines. BMC Complement Altern Med. 2017 Aug 29;17(1):425. doi: 10.1186/s12906-017-1942-6.
- Oka H, Matsudaira K, Takano Y, Kasuya D, Niiya M, Tonosu J, Fukushima M, Oshima Y, Fujii T, Tanaka S, Inanami H. A comparative study of three conservative treatments in patients with lumbar spinal stenosis: lumbar spinal stenosis with acupuncture and physical therapy study (LAP study). BMC Complement Altern Med. 2018 Jan 19;18(1):19. doi: 10.1186/s12906-018-2087-y.
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- JS-CT-2020-06