Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
- Conditions
- SciaticaIntervertebral Disc Displacement
- Interventions
- Procedure: Shinbaro pharmacopunctureDrug: Conventional medicineDevice: AcupunctureProcedure: Physical therapyBehavioral: Educational program
- Registration Number
- NCT02384928
- Lead Sponsor
- Jaseng Medical Foundation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shinbaro pharmacopuncture group Shinbaro pharmacopuncture 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. Shinbaro pharmacopuncture group Acupuncture 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. Shinbaro pharmacopuncture group Educational program 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. Acupuncture group Acupuncture 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. Acupuncture group Educational program 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. Usual care group Conventional medicine 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. Usual care group Physical therapy 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. Usual care group Educational program 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.
- Primary Outcome Measures
Name Time Method Visual analogue scale (VAS) of sciatic pain Week 5 On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
- Secondary Outcome Measures
Name Time Method Visual analogue scale (VAS) of sciatic pain Week 1, 2, 3, 4, 7, 9, 12 On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
Visual analogue scale (VAS) of low back pain (LBP) Week 1, 2, 3, 4, 5, 7, 9, 12 On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
Numeric rating scale (NRS) of sciatic pain Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 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.
Numeric rating scale (NRS) of low back pain (LBP) Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 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.
Oswestry Disability Index (ODI) Week 1, 2, 3, 4, 5, 7, 9, 12 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.
Short Form Health Survey 36 (SF-36) Week 1, 5, 7, 12 SF-36 Questionnaire consists of several questions related to local pain, radiationg pain, analgesic intake and ability.
EuroQol-5 Dimension (EQ-5D) Week 1, 5, 7, 12 Estimates that shows the quality of life(QOL).
Patient Global Impression of Change (PGIC) Week 1, 5, 7, 12 This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.
Number and percentage of participants with adverse events Week 1, 2, 3, 4, 5, 7, 9, 12 The number and percentage of participants with adverse events, categorized by affected body region, will be reported.
Trial Locations
- Locations (1)
Jaseng Hospital of Korean Medicine
🇰🇷Seoul, Gangnam-Gu, Korea, Republic of