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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

Tracking Information
First Submitted Date June 27, 2016
First Posted Date July 22, 2016
Last Update Posted Date March 29, 2019
Actual Study Start Date April 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2016)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 19, 2016)
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Lumbar Intervertebral Disc Displacement
  • Cervical Intervertebral Disc Displacement
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Drug: Herbal medicine
  • Procedure: Acupuncture
  • Procedure: Pharmacopuncture
  • Procedure: Bee venom pharmacopuncture
  • Procedure: Chuna manipulation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 24, 2017)
505
Original Estimated Enrollment
 (submitted: July 19, 2016)
500
Actual Study Completion Date January 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02841163
Other Study ID Numbers JS-CT-2016-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party In-Hyuk Ha, KMD, Jaseng Medical Foundation
Study Sponsor Jaseng Medical Foundation
Collaborators Not Provided
Investigators
Principal Investigator: Joowon Kim, KMD, M.Sc. Jaseng Medical Foundation
PRS Account Jaseng Medical Foundation
Verification Date January 2017