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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Summary:

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.

Sponsor: Jaseng Medical Foundation

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

• 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 follo
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Jaseng Medical Foundation
  

  Dates:
  Date Received: June 27, 2016
  Date Started: April 2016
  Date Completion:
  Last Updated: January 24, 2017
  Last Verified: January 2017