An observational study in Lumbar Intervertebral Disc Displacement and Cervical Intervertebral Disc Displacement, sponsored by Jaseng Medical Foundation. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Jaseng Medical Foundation · Observational
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.
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.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's enrollment of 505 is above the median of 100 across 121 observational studies indexed under Intervertebral Disc Displacement.
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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
Exclusion Criteria:
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 · Procedure: Acupuncture · Procedure: Pharmacopuncture · Procedure: Bee venom pharmacopuncture · Procedure: Chuna manipulation
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).
Also known as: Traditional herbal medicine
Acupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points.
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).
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).
Also known as: Bee venom acupuncture
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.
Also known as: Chuna spinal manipulation
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.
Time frame: 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
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post-treatment follow-up phone interview at average of 3 years
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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