Sciatica Clinical Trial
Official title:
Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
Verified date | March 2020 |
Source | Jaseng Medical Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
Status | Completed |
Enrollment | 1000 |
Est. completion date | November 8, 2019 |
Est. primary completion date | May 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years 2. Patients with radiculopathy (ipsilateral or bilateral radiculopathy) 3. Patients whose pain intensity of back pain or radiating leg pain is NRS=5 4. Patients aged 19 to 70 5. Patients who have agreed to participate in the clinical study and given written informed consent 6. Patients admitted to a Korean medicine hospital for treatment Exclusion Criteria: 1. Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation) 2. Patients admitted due to pain caused by traffic accidents 3. Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury 4. Patients with severe mental illness 5. Patients with difficulty or refusal to give sign written informed consent 6. Patients for whom the researchers judge participation in the clinical study to be difficult 7. Diagnosis of lumbar spondylolisthesis of Meyerding ? or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Bucheon Jaseng Hospital of Korean Medicine | Bucheon | Gyeonggi Province |
Korea, Republic of | Haeundae Jaseng Hospital of Korean Medicine | Busan | |
Korea, Republic of | Daejeon Jaseng Hospital of Korean Medicine | Daejeon | |
Korea, Republic of | Jaseng Hospital of Korean Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Jaseng Medical Foundation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NRS change from Baseline NRS at discharge | Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'. | Baseline (admission), discharge (up to 14 weeks after baseline) | |
Primary | ODI change from Baseline ODI at discharge | Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain. | Baseline (admission), discharge (up to 14 weeks after baseline) | |
Primary | PGIC | Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse). | 6 months after baseline | |
Secondary | EQ-5D change from Baseline EQ-5D at each time point | EuroQol-5 Dimension(EQ-5D) EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem). | Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline | |
Secondary | Lumbar ROM from Baseline Lumbar ROM at each time point | Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation) Pain upon movement in lumbar range of motion (ROM) will be assessed. | Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline) | |
Secondary | SLR from Baseline SLR at each time point | Straight Leg Raise test(SLR) The straight leg raise(SLR)is a test done during a physical examination to determine whether a patient with low back pain has an underlying herniated disc, often located at L5 (fifth lumbar spinal nerve). If the patient experiences sciatic pain when the straight leg is at an angle of between 30 and 70 degrees, then the test is positive and a herniated disk is a possible cause of the pain.[3] A negative test suggests a likely different cause for back pain. |
Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline) | |
Secondary | AE | Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs. | up to 14 weeks after baseline | |
Secondary | NRS change from Baseline NRS at each timepoint | Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'. | Baseline (admission), 2 weeks after baseline, 6 months after baseline | |
Secondary | ODI change from Baseline ODI at each timepoint | Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain. | Baseline (admission), 2 weeks after baseline, 6 months after baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02384928 -
Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
|
N/A | |
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 |