Sciatica Clinical Trial
Official title:
Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study
Verified date | July 2022 |
Source | Jaseng Medical Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture, acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 16, 2017 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | Inclusion Criteria: - Sciatica patients with an average sciatic pain NRS of 5 or higher during the preceding 3 days - Onset of at least 4 weeks previous for current sciatic pain episode - Patients whose sciatic symptoms correlate with the LDH confirmed on MRI - Patients who have agreed to follow the trial protocol Exclusion Criteria: - Patients who have received invasive treatments such as nerve blocks, pharmacopuncture, or acupuncture within the past week - Non-spinal or soft tissue pathologies which may cause LBP or sciatic pain (e.g. spinal tumors, rheumatic arthritis) - Pregnancy - History of spinal surgery, or spinal pathologies other than LDH (e.g. spinal dislocation, fracture) - Severe progressive neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness) - Patients for whom acupuncture may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine, severe diabetes with risk of infection, severe cardiovascular diseases or other conditions deemed unsuitable) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu |
Lead Sponsor | Collaborator |
---|---|
Jaseng Medical Foundation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analogue scale (VAS) of sciatic pain | On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels. | Week 5 | |
Secondary | Visual analogue scale (VAS) of sciatic pain | On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels. | Week 1, 2, 3, 4, 7, 9, 12 | |
Secondary | Visual analogue scale (VAS) of low back pain (LBP) | On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels. | Week 1, 2, 3, 4, 5, 7, 9, 12 | |
Secondary | Numeric rating scale (NRS) of low back pain (LBP) | The patient choose number between 0 to 10, which represent the serverity of the pain that he felt. 0 means there's no pain, and 10 means there's severe pain that he ever felt. | Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 | |
Secondary | Numeric rating scale (NRS) of sciatic pain | The patient choose number between 0 to 10, which represent the serverity of the pain that he felt. 0 means there's no pain, and 10 means there's severe pain that he ever felt. | Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 | |
Secondary | Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is an index is derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The ODI is a 10-item score from 0 to 100 that encompasses limitations in activity, sleeping, social life, work, and personal care resulting from low back pain. | Week 1, 2, 3, 4, 5, 7, 9, 12 | |
Secondary | Short Form Health Survey 36 (SF-36) | SF-36 Questionnaire consists of several questions related to local pain, radiationg pain, analgesic intake and ability. | Week 1, 5, 7, 12 | |
Secondary | EuroQol-5 Dimension (EQ-5D) | Estimates that shows the quality of life(QOL). | Week 1, 5, 7, 12 | |
Secondary | Patient Global Impression of Change (PGIC) | This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. | Week 1, 5, 7, 12 | |
Secondary | Number and percentage of participants with adverse events | The number and percentage of participants with adverse events, categorized by affected body region, will be reported. | Week 1, 2, 3, 4, 5, 7, 9, 12 |
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