Disc Resorption in Lumbar and Cervical Disc Herniation Patients Receiving Integrative Korean Medicine Treatment

Completed

• Conditions: Cervical Intervertebral Disc Displacement; Lumbar Intervertebral Disc Displacement
• Interventions: Drug: Herbal medicine; Procedure: Acupuncture; Procedure: Pharmacopuncture; Procedure: Bee venom pharmacopuncture; Procedure: Chuna manipulation

• Registration Number: NCT02841163
• Lead Sponsor: Jaseng Medical Foundation

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-22
• Primary Completion: 2016-10
• Study Completion: 2017-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar/cervical disc herniation group	Chuna manipulation	Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.
Lumbar/cervical disc herniation group	Herbal medicine	Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.
Lumbar/cervical disc herniation group	Acupuncture	Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.
Lumbar/cervical disc herniation group	Bee venom pharmacopuncture	Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.
Lumbar/cervical disc herniation group	Pharmacopuncture	Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.

Primary Outcome Measures

Name	Time	Method
Area of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view	Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months	Comparison of disc herniation in MRI between the baseline and post-treatment.

Secondary Outcome Measures

Name	Time	Method
Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view	Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months	Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view will be classified into 5 levels according to the method suggested by Pfirrmann et al.
Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view	Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months	Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view will be divided into 4 levels: protrusion, extrusion, sequestration, and migration
Level of herniated disc migration in patients with disc migration at disc level most relevant to patient symptoms on MR sagittal and axial view	Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months	Level of herniated disc migration in patients with disc migration will be categorized into 3 levels in accordance with the Komori classification
Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view	Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months	Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view will be classified into Modic types 0, 1, 2, and 3
Modic type change location with regard to disc level most relevant to patient symptoms on MR sagittal and axial view	Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months	Location of modic type change at the vertebrae adjacent to the herniated disc is classified by whether it is above, below, neither above nor below, or both above and below the disc level most relevant to patient symptoms on MR sagittal and axial view
Pain NRS at site of chief complaint	Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years	Low back pain NRS or neck pain NRS
Radiating pain NRS associated with site of chief complaint	Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years	Radiating leg pain NRS or radiating arm pain NRS
Whether or not patient has been recommended for surgery regarding pain at site of chief complaint	Post-treatment follow-up phone interview at average of 3 years	Whether or not patient has been recommended for surgery regarding pain at site of chief complaint will be recorded dichotomously
Whether or not pain has recurred for 1 month or longer at site of chief complaint	Post-treatment follow-up phone interview at average of 3 years	Whether or not low back pain, radiating leg pain, neck pain or radiating arm pain has recurred at site of chief complaint will be recorded dichotomously
Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint	Post-treatment follow-up phone interview at average of 3 years	Type of treatment received, if any, for pain recurrence at site of chief complaint out of Korean medicine treatment, conventional nonsurgical treatment, or surgery will be recorded
Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset	Post-treatment follow-up phone interview at average of 3 years	Whether or not patient is aware of possible spontaneous disc resorption at site of chief complaint will be recorded dichotomously
Type of treatment patient would recommend to others as primary care	Post-treatment follow-up phone interview at average of 3 years	Type of treatment patient would recommend to others out of surgical and nonsurgical treatment will be recorded
Satisfaction with integrative Korean medicine treatment	Post-treatment follow-up phone interview at average of 3 years	Satisfaction with integrative Korean medicine treatment will be recorded using a 5-point Likert scale: very dissatisfied, dissatisfied, slightly satisfied, satisfied, very satisfied
Korean medicine treatment method perceived to be most effective	Post-treatment follow-up phone interview at average of 3 years	Korean medicine treatment method perceived to be most effective out of herbal medicine, pharmacopuncture/bee venom pharmacopuncture, acupuncture, and Chuna manipulation will be recorded

Trial Locations

Locations (1)

Jaseng Medical Foundation; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of