Intervertebral Disc DisplacementNCT03571503
The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for HLD With Radiating Leg Pain
An observational study of Intervertebral Disc Displacement and Sciatica, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
A prospective pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients receiving integrative Korean medicine treatment including Doin (conduction exercise) at a Korean medicine hospital through assessment of pain, functional disability, and quality of life. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Intervertebral Disc Displacement, Sciatica, Sciatic Radiculopathy
- What is being tested?
- Doin (conduction exercise), Herbal medicine and Chuna manual therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jul 2018to 20 Sep 2019
- How long will I take part?
- 3 Months
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Herniated lumbar disc (HLD) patients with radiating leg pain
Who may be able to join
- Inpatients with radiating leg pain distal to the gluteal fold with or without low back pain (LBP)
- Patients with onset of radiating leg pain occurrence within the last six months, and current pain intensity of numeric rating scale (NRS) ≥5
- Patients with disc protrusion or extrusion at the neural segment level with significant correlations with the radiating leg pain symptoms as identified on L-spine magnetic resonance imaging (MRI)
- Patients with plans of receiving Korean medicine treatment for herniated lumbar disc (HLD) through hospitalized care
- Patients who give voluntary written informed consent to study participation
Who cannot join
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Surgery and surgical procedure in the last three weeks in areas of clinical relevance as a result of HLD
- Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
- Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
- Pregnant patients or patients planning pregnancy
- Patients with serious psychological disorders
Show all 9Show fewer
- Participating in other clinical studies other than observational studies
- Patients unable to fill out study participation consent form
- Subjects deemed unsuitable for study participation as assessed by the researchers
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
About this study
Official title: The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for Herniated Lumbar Disc (HLD) With Radiating Leg Pain: A Prospective Observational Pilot Study
A prospective pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients receiving integrative Korean medicine treatment including Doin (conduction exercise) at a Korean medicine hospital through assessment of pain, functional disability, and quality of life.
Read the detailed description
A prospective single-center observational pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients with radiating leg pain receiving integrative Korean medicine treatment including Doin (conduction exercise) of the pelvic joint at Daejeon Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, quality of life, satisfaction, and safety.
The study is expected to be performed over a period of 6 months, during the former 3 months of the study period of which the Integrative Korean medicine treatment group will be recruited, and after a wash-out period of 2 weeks, during the latter 3 months of the study period of which the Doin with integrative Korean medicine will be recruited separately.
- Being tested
- Doin (conduction exercise), Herbal medicine, Chuna manual therapy, Bee venom pharmacopuncture, Pharmacopuncture
- Keywords
- Complementary Therapies, Exercise, Acupuncture
- Medical subject headings
- Intervertebral Disc Displacement, Sciatica, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doin (conduction exercise)Procedure or surgery
Also called Doin Exercise, Do-in Exercise, Conduction Exercise
An acupuncture physician will administer acupuncture at 4-8 acupoints in the low back and gluteal area (mandatory points: BL54, and GB30 ipsilateral to the dysfunctional site; and selective points: BL23, BL24, BL25, BL26, BL31, BL32, Ah-shi points, local acupuncture points and/or trigger points. Doin (conduction exercise) will be performed as active and passive movement with the needles in situ to the aim of effective treatment of pain and functional disability by increasing the hip joint range of motion (flexion and extension) with physician guidance and isometric resistance exercise (flexion and extension) as needed. Doin (conduction exercise) sessions will be performed 1 session/day for the duration of hospitalized treatment while the patient presents radiating leg pain (NRS≥1).
Herbal medicineDrug
Also called Traditional herbal medicine
Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Chuna manual therapyProcedure or surgery
Also called Chuna manipulation, Chuna spinal manipulation
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint 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 will be administered at the physician's discretion.
Bee venom pharmacopunctureProcedure or surgery
Also called Bee venom acupuncture
Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be 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).
PharmacopunctureProcedure or surgery
Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
AcupunctureProcedure or surgery
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
ElectroacupunctureProcedure or surgery
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
CuppingProcedure or surgery
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)Other
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Korean medicine treatment | Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed. Receives: Drug: Herbal medicine; Procedure: Chuna manual therapy; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s) | |
| Doin with integrative Korean medicine | Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture. Receives: Procedure: Doin (conduction exercise); Drug: Herbal medicine; Procedure: Chuna manual therapy; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Rating Scale (NRS) of low back pain
Change in low back pain intensity at 2 weeks as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Measured: Baseline, 2 weeks post-baseline
Change in Numeric Rating Scale (NRS) of radiating leg pain
Change in radiating leg pain intensity at 2 weeks as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Measured: Baseline, 2 weeks post-baseline
Change in Oswestry Disability Index (ODI)
Functional disability questionnaire at 2 weeks as measured using ODI. The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.
Measured: Baseline, 2 weeks post-baseline
Secondary outcomes (18)
Numeric Rating Scale (NRS) of low back pain
Low back pain intensity as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Numeric Rating Scale (NRS) of radiating leg pain
Radiating leg pain intensity as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Oswestry Disability Index (ODI)
Functional disability questionnaire as measured using ODI. The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Visual Analogue Scale (VAS) of radiating leg pain
Radiating leg pain intensity as measured using VAS. VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Measured: Baseline, 3, 7, 10, 14 days post-baseline
Visual Analogue Scale (VAS) of low back pain
Low back pain intensity as measured using VAS. VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Measured: Baseline, 3, 7, 10, 14 days post-baseline
EuroQol 5-Dimension (EQ-5D)
Health-related quality of life questionnaire as measured using SF-36. SF-36 consists of 36 items across 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. SF-36 is used to rate functional health and well-being in patients and healthy individuals. Higher scores indicate better HRQoL.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Patient Global Impression of Change (PGIC)
Global patient-reported outcome as measured using PGIC. PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Measured: Baseline, 14, 30, 90 days post-baseline
Drug Consumption (drug type)
Regarding recent use of medication, the type of prescription intake for medicine will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Drug Consumption (drug intake frequency)
Regarding recent use of medication, the frequency of prescription intake for medicine will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Drug Consumption (drug intake period)
Regarding recent use of medication, the period of prescription intake for medicine will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Use of additional medical treatment (treatment type)
Regarding current use of medical services, the type of additional medical treatment received will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Use of additional medical treatment (treatment frequency)
Regarding current use of medical services, the frequency of additional medical treatment received will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Use of additional medical treatment (treatment period)
Regarding current use of medical services, the period of additional medical treatment received will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Details of Doin conduction exercise sessions (type (region))
Administration details of Doin conduction exercise session type (region) will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Details of Doin conduction exercise sessions (period)
Administration details of Doin conduction exercise sessions (period) will be recorded.
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Lumbar range of movement (ROM)
Physical examination
Measured: Baseline, 3, 7, 10, 14 days post-baseline
Straight leg raise (SLR) test
Physical examination
Measured: Baseline, 3, 7, 10, 14 days post-baseline
Adverse events
Safety outcome
Measured: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start9 Jul 2018
- Primary completion4 Jul 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KIMMINYOUNG, Jaseng Medical Foundation
- Investigators
- Min-young Kim, KMD, Principal investigator, Daejeon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571503
- Sponsor's protocol ID
- JS-CT-2018-02
- Status last verified
- Nov 2019
- First submitted
- 1 Jun 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for Herniated Lumbar Disc (HLD) With Radiating Leg Pain: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03571503
- Acronym / sponsor ID
- JS-CT-2018-02
- Keywords
- Complementary Therapies, Exercise, Acupuncture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- 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.
A prospective pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients receiving integrative Korean medicine treatment including Doin (conduction exercise) at a Korean medicine hospital through assessment of pain, functional disability, and quality of life.
Detailed description
A prospective single-center observational pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients with radiating leg pain receiving integrative Korean medicine treatment including Doin (conduction exercise) of the pelvic joint at Daejeon Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, quality of life, satisfaction, and safety.
The study is expected to be performed over a period of 6 months, during the former 3 months of the study period of which the Integrative Korean medicine treatment group will be recruited, and after a wash-out period of 2 weeks, during the latter 3 months of the study period of which the Doin with integrative Korean medicine will be recruited separately.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Korean medicine treatment | – | Drug: Herbal medicine, Procedure: Chuna manual therapy, Procedure: Bee venom pharmacopuncture, Procedure: Pharmacopuncture, Procedure: Acupuncture, Procedure: Electroacupuncture, Procedure: Cupping, Other: Other intervention(s)Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed. |
| Doin with integrative Korean medicine | – | Procedure: Doin (conduction exercise), Drug: Herbal medicine, Procedure: Chuna manual therapy, Procedure: Bee venom pharmacopuncture, Procedure: Pharmacopuncture, Procedure: Acupuncture, Procedure: Electroacupuncture, Procedure: Cupping, Other: Other intervention(s)Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Herniated lumbar disc (HLD) patients with radiating leg pain
Key inclusion criteria (5 listed)
- Inpatients with radiating leg pain distal to the gluteal fold with or without low back pain (LBP)
- Patients with onset of radiating leg pain occurrence within the last six months, and current pain intensity of numeric rating scale (NRS) ≥5
- Patients with disc protrusion or extrusion at the neural segment level with significant correlations with the radiating leg pain symptoms as identified on L-spine magnetic resonance imaging (MRI)
- Patients with plans of receiving Korean medicine treatment for herniated lumbar disc (HLD) through hospitalized care
- Patients who give voluntary written informed consent to study participation
Key exclusion criteria (9 listed)
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Surgery and surgical procedure in the last three weeks in areas of clinical relevance as a result of HLD
- Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
- Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
- Pregnant patients or patients planning pregnancy
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 |
|---|---|---|
| Doin (conduction exercise)Also: Doin Exercise, Do-in Exercise, Conduction ExerciseAn acupuncture physician will administer acupuncture at 4-8 acupoints in the low back and gluteal area (mandatory points: BL54, and GB30 ipsilateral to the dysfunctional site; and selective points: BL23, BL24, BL25, BL26, BL31, BL32, Ah-shi points, local acupuncture points and/or trigger points. Doin (conduction exercise) will be performed as active and passive movement with the needles in situ to the aim of effective treatment of pain and functional disability by increasing the hip joint range of motion (flexion and extension) with physician guidance and isometric resistance exercise (flexion and extension) as needed. Doin (conduction exercise) sessions will be performed 1 session/day for the duration of hospitalized treatment while the patient presents radiating leg pain (NRS≥1). | Procedure or surgery | Doin with integrative Korean medicine |
| Herbal medicineAlso: Traditional herbal medicineHerbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: 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 | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| Chuna manual therapyAlso: Chuna manipulation, Chuna spinal manipulationChuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint 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 will be administered at the physician's discretion. | Procedure or surgery | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| Bee venom pharmacopunctureAlso: Bee venom acupunctureBee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be 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 | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| PharmacopuncturePharmacopuncture consisting of select herbal ingredients will be administered at 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 | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| AcupunctureAcupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| ElectroacupunctureElectroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| CuppingCupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
| Other intervention(s)Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study. | Other | Doin with integrative Korean medicine, Integrative Korean medicine treatment |
Primary outcome
Change in Numeric Rating Scale (NRS) of low back pain
Time frame: Baseline, 2 weeks post-baseline
Change in low back pain intensity at 2 weeks as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Change in Numeric Rating Scale (NRS) of radiating leg pain
Time frame: Baseline, 2 weeks post-baseline
Change in radiating leg pain intensity at 2 weeks as measured using NRS. In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Change in Oswestry Disability Index (ODI)
Time frame: Baseline, 2 weeks post-baseline
Functional disability questionnaire at 2 weeks as measured using ODI. The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.
18 secondary outcomes
Numeric Rating Scale (NRS) of low back pain
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Numeric Rating Scale (NRS) of radiating leg pain
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Oswestry Disability Index (ODI)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Visual Analogue Scale (VAS) of radiating leg pain
Time frame: Baseline, 3, 7, 10, 14 days post-baseline
Visual Analogue Scale (VAS) of low back pain
Time frame: Baseline, 3, 7, 10, 14 days post-baseline
EuroQol 5-Dimension (EQ-5D)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Patient Global Impression of Change (PGIC)
Time frame: Baseline, 14, 30, 90 days post-baseline
Drug Consumption (drug type)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Drug Consumption (drug intake frequency)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Drug Consumption (drug intake period)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Use of additional medical treatment (treatment type)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Use of additional medical treatment (treatment frequency)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Use of additional medical treatment (treatment period)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Details of Doin conduction exercise sessions (type (region))
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Details of Doin conduction exercise sessions (period)
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Lumbar range of movement (ROM)
Time frame: Baseline, 3, 7, 10, 14 days post-baseline
Straight leg raise (SLR) test
Time frame: Baseline, 3, 7, 10, 14 days post-baseline
Adverse events
Time frame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
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 4 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Min-young Kim, KMD principal investigator
Daejeon Jaseng Hospital of Korean Medicine
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 Intervertebral Disc Displacement and Sciatica, 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 5 inclusion and 9 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 4 Nov 2019. 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?
Change in Numeric Rating Scale (NRS) of low back pain (time frame: Baseline, 2 weeks post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2019.