Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02384928
Study type	Interventional
Source	Jaseng Medical Foundation
Contact
Status	Completed
Phase	N/A
Start date	September 9, 2015
Completion date	March 16, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05626140` - COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA	Phase 3
Withdrawn	`NCT02313350` - Intradiscal Discogel® in Resistant Sciatica	N/A
Unknown status	`NCT02512081` - "The Lived Experience of Investigations for Sciatica"	N/A
Recruiting	`NCT06179901` - The Effect of Early MSAT Treatment on Sciatica Caused by Traffic Accidents	N/A
Terminated	`NCT02951377` - Mechanical Diagnosis and Treatment and/or Steroid Injections for Lumbar Radiculopathy	Phase 1
Completed	`NCT03347929` - NSAIDs in Sciatica NSAIDS IN SCIATICA	Phase 4
Completed	`NCT04145310` - BOL-DP-o-04 in Patients With Low Back Pain and Sciatica	Phase 1/Phase 2
Enrolling by invitation	`NCT04660656` - Predictive Value of the Five-repetition Sit-to-stand Test After Lumbar Spine surgerySTS-3 Study.
Completed	`NCT02644421` - Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)	Phase 1
Completed	`NCT00991172` - A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain	Phase 2
Completed	`NCT00668434` - Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica	Phase 2
Completed	`NCT00749996` - Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease	Phase 4
Completed	`NCT00246948` - The Efficacy of Active Conservative Treatment for Patients With Severe Sciatica. A Randomized Clinical Controlled Trial	N/A
Completed	`NCT04155450` - Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome	N/A
Completed	`NCT02284542` - NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
Recruiting	`NCT02770963` - Efficacy of Acupuncture for Discogenic Sciatica	N/A
Completed	`NCT00364572` - Efficacy of Epidural Etanercept in the Treatment of Sciatica	Phase 1/Phase 2
Completed	`NCT00470509` - Adalimumab in Severe and Acute Sciatica	Phase 2
Active, not recruiting	`NCT03887962` - Virtual Environment Rehabilitation for Patients With Motor Neglect Trial	N/A
Completed	`NCT05959317` - Effects of Pilates Exercises and Neural Dynamic Mobilization in Sciatica Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms