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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.
This study is a three-armed, randomized, patient, physician, and assessor-blinded, controlled pilot to the aim of evaluating 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, onset between 4 weeks and 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture+acupuncture), acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shinbaro pharmacopuncture group | Experimental | The Shinbaro pharmacopuncture group will receive 8 interventional sessions of Shinbaro pharmacopuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week. |
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| Acupuncture group | Active Comparator | The acupuncture group will receive 8 interventional sessions of acupuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and 5 other acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week. |
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| Usual care group | Active Comparator | The usual care group will receive conventional medicine 2 times/day and 2 sessions/week of physical therapy over 4 weeks. Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics, which include aceclofenac, tramadol hydrochloride, talniflumate, diclofenac sodium, and loxoprofen sodium. All groups will take 4 educational program sessions supervised by physicians once a week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shinbaro pharmacopuncture | Procedure | Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints. One Hyeopcheok (Huatuo Jiaji, EX B2) acupoint most relevant to patient symptoms with reference to MRI will be administered Shinbaro pharmacopuncture. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visual analogue scale (VAS) of low back pain (LBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinho Lee | Jaseng Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu | 135-896 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26459006 | Derived | Lee J, Shin JS, Lee YJ, Kim MR, Ahn YJ, Park KB, Kropf MA, Shin BC, Lee MS, Ha IH. Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:455. doi: 10.1186/s13063-015-0993-6. |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Acupuncture | Device | Five acupoints will be needled to about 1cm depth assisted by an acupuncture guide tube with no manual stimulation such as twirling or lifting and thrusting. |
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| Conventional medicine | Drug | Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. The most frequently prescribed conventional drugs for LDH include aceclofenac (Drug class: nonsteroidal antiinflammatoy drugs (NSAIDs)), tramadol hydrochloride (Drug class: Opioids), talniflumate (Drug class: NSAIDs), diclofenac sodium (Drug class: NSAIDs), and loxoprofen sodium (Drug class: NSAIDs). |
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| Physical therapy | Procedure | Physical therapy will be prescribed with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. |
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| Educational program | Behavioral | Educational program sessions supervised by physicians will be provided once a week for 4 weeks.The education program will inform the patient of the favorable prognosis of LDH, and instructions for everyday activities and self-management. The education program will consist of handbooks handed out to each participant, and weekly reminders and encouragement from the physician. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| EuroQol-5 Dimension (EQ-5D) | Estimates that shows the quality of life(QOL). | Week 1, 5, 7, 12 |
| 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 |
| 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 |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |