Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384928
• Other study ID #: JS-CT-2015-03
• Status: Completed
• Phase: N/A
• Start date: September 9, 2015
• Est. completion date: March 16, 2017

Study information

• Verified date: July 2022
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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)

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Sciatica

Intervention

Procedure:
• Shinbaro pharmacopuncture
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.

Device:
• Acupuncture
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.

Drug:
• Conventional medicine
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).

Procedure:
• Physical therapy
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.

Behavioral:
• Educational program
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.

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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