Lumbar Intervertebral Disc DisplacementNCT02841163
Disc Resorption in Lumbar and Cervical Disc Herniation Patients Receiving Integrative Korean Medicine Treatment
An observational study of Lumbar Intervertebral Disc Displacement and Cervical Intervertebral Disc Displacement, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Intervertebral Disc Displacement, Cervical Intervertebral Disc Displacement
- What is being tested?
- Herbal medicine, Acupuncture and Pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 505 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Participants refusing to participate in study or to respond to phone interview.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Medical Foundation
Bucheon-si, Gyeonggi Province, 14598
About this study
Official title: Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral 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.
Read the 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.
- Being tested
- Herbal medicine, Acupuncture, Pharmacopuncture, Bee venom pharmacopuncture, Chuna manipulation
- Keywords
- Magnetic Resonance Imaging, Patient Satisfaction, Numeric Rating Scale
- Medical subject headings
- Intervertebral Disc Displacement, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicineDrug
Also called Traditional 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).
AcupunctureProcedure or surgery
Acupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points.
PharmacopunctureProcedure or surgery
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 pharmacopunctureProcedure or surgery
Also called Bee venom acupuncture
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).
Chuna manipulationProcedure or surgery
Also called Chuna spinal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Herbal medicine; Procedure: Acupuncture; Procedure: Pharmacopuncture; Procedure: Bee venom pharmacopuncture; Procedure: Chuna manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
Level of herniated disc migration in patients with disc migration will be categorized into 3 levels in accordance with the Komori classification
Measured: 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
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
Measured: 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
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
Measured: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Pain NRS at site of chief complaint
Low back pain NRS or neck pain NRS
Measured: Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
Radiating pain NRS associated with site of chief complaint
Radiating leg pain NRS or radiating arm pain NRS
Measured: Change from baseline MRI (taken before treatment) at 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
Whether or not patient has been recommended for surgery regarding pain at site of chief complaint will be recorded dichotomously
Measured: Post-treatment follow-up phone interview at average of 3 years
Whether or not pain has recurred for 1 month or longer at site of chief complaint
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
Measured: Post-treatment follow-up phone interview at average of 3 years
Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint
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
Measured: Post-treatment follow-up phone interview at average of 3 years
Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset
Whether or not patient is aware of possible spontaneous disc resorption at site of chief complaint will be recorded dichotomously
Measured: Post-treatment follow-up phone interview at average of 3 years
Type of treatment patient would recommend to others as primary care
Type of treatment patient would recommend to others out of surgical and nonsurgical treatment will be recorded
Measured: Post-treatment follow-up phone interview at average of 3 years
Satisfaction with integrative Korean medicine treatment
Satisfaction with integrative Korean medicine treatment will be recorded using a 5-point Likert scale: very dissatisfied, dissatisfied, slightly satisfied, satisfied, very satisfied
Measured: Post-treatment follow-up phone interview at average of 3 years
Korean medicine treatment method perceived to be most effective
Korean medicine treatment method perceived to be most effective out of herbal medicine, pharmacopuncture/bee venom pharmacopuncture, acupuncture, and Chuna manipulation will be recorded
Measured: Post-treatment follow-up phone interview at average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Intervertebral Disc DisplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- Joowon Kim, KMD, M.Sc., Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841163
- Sponsor's protocol ID
- JS-CT-2016-06
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2016
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 28769985
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral Disc Herniation Patients Receiving Integrative Korean Medicine Treatment
- ClinicalTrials.gov ID
- NCT02841163
- Acronym / sponsor ID
- JS-CT-2016-06
- Keywords
- Magnetic Resonance Imaging, Patient Satisfaction, Numeric Rating Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar/cervical disc herniation group | – | Drug: Herbal medicine, Procedure: Acupuncture, Procedure: Pharmacopuncture, Procedure: Bee venom pharmacopuncture, Procedure: Chuna manipulationLumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants refusing to participate in study or to respond to phone interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal medicineAlso: Traditional herbal medicineHerbal 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). | Drug | Lumbar/cervical disc herniation group |
| AcupunctureAcupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Lumbar/cervical disc herniation group |
| PharmacopunctureSelect 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 or surgery | Lumbar/cervical disc herniation group |
| Bee venom pharmacopunctureAlso: Bee venom acupunctureBee 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). | Procedure or surgery | Lumbar/cervical disc herniation group |
| Chuna manipulationAlso: Chuna spinal manipulationChuna 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. | Procedure or surgery | Lumbar/cervical disc herniation group |
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
Comparison of disc herniation in MRI between the baseline and post-treatment.
14 secondary outcomes
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 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 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
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 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
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
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
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 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
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
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
Type of treatment patient would recommend to others as primary care
Time frame: Post-treatment follow-up phone interview at average of 3 years
Satisfaction with integrative Korean medicine treatment
Time frame: Post-treatment follow-up phone interview at average of 3 years
Korean medicine treatment method perceived to be most effective
Time frame: Post-treatment follow-up phone interview at average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 28769985Lee 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.
- Individual participant dataSharing planned: No
Related trials for Lumbar Intervertebral Disc Displacement
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joowon Kim, KMD, M.Sc. principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Intervertebral Disc Displacement and Cervical Intervertebral Disc Displacement, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02841163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.