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NCT Number: NCT02841163

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

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.

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Key information

Conditions

Lumbar Intervertebral Disc Displacement Behavior Bone Diseases Cervical Intervertebral Disc Displacement Health Behavior Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Patient Satisfaction Spinal Diseases Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Bucheon-si, Gyeonggi Province, 14598, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Herbal medicine

Drug

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 names: Traditional herbal medicine

Acupuncture

Procedure

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

Pharmacopuncture

Procedure

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

Procedure

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 names: Bee venom acupuncture

Chuna manipulation

Procedure

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 names: Chuna spinal manipulation

Primary outcomes

  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

    Comparison of disc herniation in MRI between the baseline and post-treatment.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 22, 2016
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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