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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral Disc Herniation Patients Receiving Integrative Korean Medicine Treatment

Conditions
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Lumbar Intervertebral Disc Displacement, Cervical Intervertebral Disc Displacement

Intervention / Treatment
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* Procedure: Bee venom pharmacopuncture
* Procedure: Chuna manipulation
* Drug: Herbal medicine
* Procedure: Acupuncture
* Procedure: Pharmacopuncture


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar/cervical disc herniation group<br>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. | Drug: Herbal medicine<br>* Herbal medicine was administered 2-3 times daily in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).<br>* Other names: Traditional herbal medicine;Procedure: Acupuncture<br>* Acupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points.<br>Procedure: Pharmacopuncture<br>* Select herbal ingredients (Eucommia ulmoides cortex, Acanthopanax sessiliflorum cortex, Achyranthis bidentata radix, Saposhnikovia divaricata radix, Cibotium barometz rhizoma, Paeonia albiflora radix alba, Ostericum koreanum radix, Angelica pubescens radix, and Scolopendra subspinipes corpus (Paeonia albiflora twice the proportion of that of other ingredients)) were freeze dried into powder form after decoction, then diluted in water-for-injection and adjusted for acidity and pH. Pharmacopuncture was administered once daily at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).<br>Procedure: Bee venom pharmacopuncture<br>* Bee venom pharmacopuncture was administered only after confirming a negative response to hypersensitivity skin tests. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens was injected at 4-5 acupoints proximal to the painful site at the physician's discretion. Each acupuncture point was injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).<br>* Other names: Bee venom acupuncture;Procedure: Chuna manipulation<br>* Chuna is a Korean version of spinal manipulation that incorporates spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation was administered 3-5 times a week to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.<br>* Other names: Chuna spinal manipulation;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view | 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. | 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 | 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 | 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 at disc level most relevant to patient symptoms on MR sagittal and axial view | Level of herniated disc migration in patients with disc migration will be categorized into 3 levels in accordance with the Komori classification | 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 | 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 | Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months | 
| Modic type change location with regard to disc level most relevant to patient symptoms on MR sagittal and axial view | 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 | Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months | 
| Pain NRS at site of chief complaint | Low back pain NRS or neck pain NRS | Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years | 
| Radiating pain NRS associated with site of chief complaint | Radiating leg pain NRS or radiating arm pain NRS | Change from baseline MRI (taken before treatment) at 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 | Whether or not patient has been recommended for surgery regarding pain at site of chief complaint will be recorded dichotomously | Post-treatment follow-up phone interview at average of 3 years | 
| Whether or not pain has recurred for 1 month or longer at site of chief complaint | 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 | Post-treatment follow-up phone interview at average of 3 years | 
| Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint | 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 | Post-treatment follow-up phone interview at average of 3 years | 
| Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset | Whether or not patient is aware of possible spontaneous disc resorption at site of chief complaint will be recorded dichotomously | Post-treatment follow-up phone interview at average of 3 years | 
| Type of treatment patient would recommend to others as primary care | Type of treatment patient would recommend to others out of surgical and nonsurgical treatment will be recorded | Post-treatment follow-up phone interview at average of 3 years | 
| Satisfaction with integrative Korean medicine treatment | Satisfaction with integrative Korean medicine treatment will be recorded using a 5-point Likert scale: very dissatisfied, dissatisfied, slightly satisfied, satisfied, very satisfied | Post-treatment follow-up phone interview at average of 3 years | 
| Korean medicine treatment method perceived to be most effective | Korean medicine treatment method perceived to be most effective out of herbal medicine, pharmacopuncture/bee venom pharmacopuncture, acupuncture, and Chuna manipulation will be recorded | Post-treatment follow-up phone interview at average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Patient Satisfaction, Numeric Rating Scale