Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.

Spinal Stenosis Lumbar Clinical Trial

Official title:

Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443738
• Other study ID #: JS-CT-2020-06
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: September 16, 2020

Study information

• Verified date: July 2022
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.

• Patients undergone MRI readings of central spinal stenosis

• Patients have no communication problems

• Patients have agreed to participate the study.

Exclusion Criteria:

• 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)

• Patient hospitalized for pain caused by a traffic accident

• Patients with serious mental illness

• Patients deemed unable to participate in the clinical research by other researchers

Related Conditions & MeSH terms

• Constriction, Pathologic
• Medicine, Korean Traditional
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Medical Foundation	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (20)

Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. — View Citation

Bodeker G. Lessons on integration from the developing world's experience. BMJ. 2001 Jan 20;322(7279):164-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View Citation

Hadianfard MJ, Aminlari A, Daneshian A, Safarpour AR. Effect of Acupuncture on Pain and Quality of Life in Patients with Lumbar Spinal Stenosis: A Case Series Study. J Acupunct Meridian Stud. 2016 Aug;9(4):178-82. doi: 10.1016/j.jams.2015.11.032. Epub 2015 Nov 17. — View Citation

Jeon CH, Kim DJ, Kim SK, Kim DJ, Lee HM, Park HJ. Validation in the cross-cultural adaptation of the Korean version of the Oswestry Disability Index. J Korean Med Sci. 2006 Dec;21(6):1092-7. — View Citation

Jung B, Bae S, Kim S. Use of Western Medicine and Traditional Korean Medicine for Joint Disorders: A Retrospective Comparative Analysis Based on Korean Nationwide Insurance Data. Evid Based Complement Alternat Med. 2017;2017:2038095. doi: 10.1155/2017/2038095. Epub 2017 Dec 6. — View Citation

Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009 Jul;9(7):545-50. doi: 10.1016/j.spinee.2009.03.005. Epub 2009 Apr 23. — View Citation

Kim K, Jeong Y, Youn Y, Choi J, Kim J, Chung W, Kim TH. Nonoperative Korean Medicine Combination Therapy for Lumbar Spinal Stenosis: A Retrospective Case-Series Study. Evid Based Complement Alternat Med. 2015;2015:263898. doi: 10.1155/2015/263898. Epub 2015 Oct 12. — View Citation

Kim KH, Kim TH, Lee BR, Kim JK, Son DW, Lee SW, Yang GY. Acupuncture for lumbar spinal stenosis: a systematic review and meta-analysis. Complement Ther Med. 2013 Oct;21(5):535-56. doi: 10.1016/j.ctim.2013.08.007. Epub 2013 Aug 20. Review. — View Citation

Kim KH, Kim YR, Baik SK, Noh SH, Kim DH, Lee SW, Yang GY. Acupuncture for patients with lumbar spinal stenosis: a randomised pilot trial. Acupunct Med. 2016 Aug;34(4):267-74. doi: 10.1136/acupmed-2015-010962. Epub 2016 Mar 7. — View Citation

Kim SH, Ahn J, Ock M, Shin S, Park J, Luo N, Jo MW. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016 Jul;25(7):1845-52. doi: 10.1007/s11136-015-1205-2. Epub 2016 Mar 10. — View Citation

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. — View Citation

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. — View Citation

Patel J, Osburn I, Wanaselja A, Nobles R. Optimal treatment for lumbar spinal stenosis: an update. Curr Opin Anaesthesiol. 2017 Oct;30(5):598-603. doi: 10.1097/ACO.0000000000000495. Review. — View Citation

Qin Z, Ding Y, Xu C, Kwong JSW, Ji Y, Wu A, Wu J, Liu Z. Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial. Am J Med. 2020 Apr;133(4):500-507.e20. doi: 10.1016/j.amjmed.2019.08.038. Epub 2019 Sep 13. — View Citation

Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States' trends and regional variations in lumbar spine surgery: 1992-2003. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2707-14. — View Citation

Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 August 2020
Secondary	Oswestry disability index (ODI)	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	Finish survey by August 2020
Secondary	The five level version of EuroQol-5 Dimension (EQ-5D)	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	Finish survey by August 2020
Secondary	Patient Global Impression of Change (PGIC)	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).	Finish survey by August 2020
Secondary	Spine surgery	The number of spinal surgery after discharge	Finish survey by August 2020
Secondary	Current symptoms	Possible walking time without pain, neurological claudication	Finish survey by August 2020
Secondary	Treatment after discharge	Treatment history in the last month	Finish survey by August 2020
Secondary	hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine	Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.	Finish survey by August 2020