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

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ClinicalTrials.gov Identifier: NCT02841163
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, KMD, 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.

Condition or disease Intervention/treatment
Lumbar Intervertebral Disc Displacement Cervical Intervertebral Disc Displacement Drug: Herbal medicine Procedure: Acupuncture Procedure: Pharmacopuncture Procedure: Bee venom pharmacopuncture Procedure: Chuna manipulation

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.

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Study Type : Observational
Actual Enrollment : 505 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral Disc Herniation Patients Receiving Integrative Korean Medicine Treatment
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lumbar/cervical disc herniation group
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
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).
Other Name: Traditional herbal medicine

Procedure: Acupuncture
Acupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points.

Procedure: Pharmacopuncture
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).

Procedure: Bee venom pharmacopuncture
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).
Other Name: Bee venom acupuncture

Procedure: Chuna manipulation
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.
Other Name: Chuna spinal manipulation




Primary Outcome Measures :
  1. Area of disc herniation at 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 ]

Secondary Outcome Measures :
  1. Level of disc degeneration at 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 ]
    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.

  2. Level of disc herniation at 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 ]
    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

  3. Level of herniated disc migration in patients with disc migration at 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 ]
    Level of herniated disc migration in patients with disc migration will be categorized into 3 levels in accordance with the Komori classification

  4. Modic type change at vertebrae adjacent to 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 ]
    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

  5. Modic type change location with regard to 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 ]
    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

  6. Pain NRS at site of chief complaint [ Time Frame: 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

  7. Radiating pain NRS associated with site of chief complaint [ Time Frame: 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

  8. Whether or not patient has been recommended for surgery regarding pain at site of chief complaint [ Time Frame: 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

  9. Whether or not pain has recurred for 1 month or longer at site of chief complaint [ Time Frame: 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

  10. Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint [ Time Frame: 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

  11. Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset [ Time Frame: 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

  12. Type of treatment patient would recommend to others as primary care [ Time Frame: 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

  13. Satisfaction with integrative Korean medicine treatment [ Time Frame: 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

  14. Korean medicine treatment method perceived to be most effective [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841163


Locations
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Korea, Republic of
Jaseng Medical Foundation
Bucheon, Gyeonggi Province, Korea, Republic of, 14598
Sponsors and Collaborators
Jaseng Medical Foundation
Investigators
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Principal Investigator: Joowon Kim, KMD, M.Sc. Jaseng Medical Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT02841163    
Other Study ID Numbers: JS-CT-2016-06
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by In-Hyuk Ha, KMD, Jaseng Medical Foundation:
Magnetic Resonance Imaging
Patient Satisfaction
Numeric Rating Scale
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Hernia
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases