Clinical trial NCT02841163: Disc Resorption in Lumbar and Cervical Disc Herniation Patients Receiving Integrative Korean Medicine Treatment
Official title: Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral Disc Herniation Patients Receiving Integrative Korean Medicine Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Intervertebral Disc Displacement
Cervical Intervertebral Disc Displacement
Keywords: Magnetic Resonance Imaging
Patient Satisfaction
Numeric Rating Scale
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 505
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lumbar and/or cervical disc herniation patients with MRI results before and after receiving treatment at Jaseng Hospital of Korean Medicine between February 2012 and December 2015

Brief summary: Measurement of herniated disc resorption and assessment of satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results receiving treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

Detailed description: Intervertebral disc herniation treatment can be largely divided into conservative and surgical approaches, and the greater majority of patients show relief of symptoms and resorption of herniated disc through non-surgical, conservative management. Despite concerns that early surgical interventions in intervertebral disc herniation without allowing for sufficient conservative treatment may indicate overtreatment, awareness and understanding in the general public is found somewhat lacking.

The objective of this study is to measure herniated disc resorption and assess satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results before and after receiving conservative treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

Eligibility criteria: Inclusion Criteria:

* Lumbar and/or cervical disc herniation patients with baseline MRI and follow-up results after receiving treatment at Jaseng Hospital of Korean Medicine visiting between February 2012 and December 2015.
* Participants giving informed written consent to use of medical records for academic means.

Exclusion Criteria:

* Participants refusing to participate in study or to respond to phone interview.

Primary outcomes:
measure: Area of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Secondary outcomes:
measure: Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
measure: Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
measure: Level of herniated disc migration in patients with disc migration at disc level most relevant to patient symptoms on MR sagittal and axial view
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
measure: Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
measure: Modic type change location with regard to disc level most relevant to patient symptoms on MR sagittal and axial view
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
measure: Pain NRS at site of chief complaint
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
measure: Radiating pain NRS associated with site of chief complaint
timeFrame: Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
measure: Whether or not patient has been recommended for surgery regarding pain at site of chief complaint
timeFrame: Post-treatment follow-up phone interview at average of 3 years
measure: Whether or not pain has recurred for 1 month or longer at site of chief complaint
timeFrame: Post-treatment follow-up phone interview at average of 3 years
measure: Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint
timeFrame: Post-treatment follow-up phone interview at average of 3 years
measure: Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset
timeFrame: Post-treatment follow-up phone interview at average of 3 years
measure: Type of treatment patient would recommend to others as primary care
timeFrame: Post-treatment follow-up phone interview at average of 3 years
measure: Satisfaction with integrative Korean medicine treatment
timeFrame: Post-treatment follow-up phone interview at average of 3 years
measure: Korean medicine treatment method perceived to be most effective
timeFrame: Post-treatment follow-up phone interview at average of 3 years
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Jaseng Medical Foundation
state: Gyeonggi Province
Study officials:
affiliation: Jaseng Medical Foundation
name: Joowon Kim, KMD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee J, Kim J, Shin JS, Lee YJ, Kim MR, Jeong SY, Choi YJ, Yoon TK, Moon BH, Yoo SB, Hong J, Ha IH. Long-Term Course to Lumbar Disc Resorption Patients and Predictive Factors Associated with Disc Resorption. Evid Based Complement Alternat Med. 2017;2017:2147408. doi: 10.1155/2017/2147408. Epub 2017 Jul 9.