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

NCT02841163 | Completed

• 1 other identifier: JS-CT-2016-06
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Intervertebral Disc Displacement; Cervical Intervertebral Disc Displacement

Keywords

Magnetic Resonance Imaging; Patient Satisfaction; Numeric Rating Scale

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months

Secondary Outcomes (14)

• Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view

  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

  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

  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

  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

  Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months

Study Arms (1)

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; Procedure: Acupuncture; Procedure: Pharmacopuncture; Procedure: Bee venom pharmacopuncture; Procedure: Chuna manipulation

Interventions

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).

Also known as: Traditional herbal medicine

Lumbar/cervical disc herniation group

Acupuncture PROCEDURE

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

Lumbar/cervical disc herniation group

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).

Lumbar/cervical disc herniation group

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).

Also known as: Bee venom acupuncture

Lumbar/cervical disc herniation group

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.

Also known as: Chuna spinal manipulation

Lumbar/cervical disc herniation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Participants refusing to participate in study or to respond to phone interview.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28769985 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Patient Satisfaction

Interventions

Phytotherapy; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joowon Kim, KMD, M.Sc.

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 22, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)