Trials / Completed
CompletedNCT03750591
Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (actual)
- Sponsor
- Jaseng Medical Foundation · Academic / Other
- Sex
- All
- Age
- 19 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
Detailed description
Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction with an observational study to the aim of evaluating the effectiveness and safety of Korean medicine treatment for inpatients
Conditions
- Sciatica Due to Intervertebral Disc Disorder
- Intervertebral Disc Displacement
- Sciatica
- Sciatic Radiculopathy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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). |
| PROCEDURE | Chuna manual therapy | Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, 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 | Bee venom pharmacopuncture | 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, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea). |
| PROCEDURE | Pharmacopuncture | Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea). |
| PROCEDURE | Acupuncture | Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. |
| PROCEDURE | Electroacupuncture | Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. |
| PROCEDURE | Cupping | Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. |
| OTHER | 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. |
Timeline
- Start date
- 2018-03-31
- Primary completion
- 2019-05-10
- Completion
- 2019-11-08
- First posted
- 2018-11-23
- Last updated
- 2020-03-13
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03750591. Inclusion in this directory is not an endorsement.