Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/spondylolisthesis
- Conditions
- Lumbar Spinal StenosisLumbar SpondylolisthesisLow Back PainNeurogenic ClaudicationSciatica
- Interventions
- Drug: Herbal medicineProcedure: Chuna manual medicineProcedure: Bee venom pharmacopunctureProcedure: PharmacopunctureProcedure: AcupunctureProcedure: ElectroacupunctureProcedure: CuppingProcedure: Other intervention(s)
- Registration Number
- NCT03879447
- Lead Sponsor
- Jaseng Medical Foundation
- Brief Summary
A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica at 3 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes
- Detailed Description
This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica diagnosed by lumbar X-ray and/or MRI and clinical symptoms including neurogenic claudication at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes with a 5-year follow-up period
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Patients with radiating leg pain or low back pain (LBP) intensity of NRS ≥5
- Patients diagnosed with lumbar stenosis based on dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI; or patients diagnosed with lumbar spondylolisthesis based on Meyerding Grade Ⅱ or higher as assessed on X-ray
- Clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position), if lumbar stenosis patient
- Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥4 months
- Patients who have agreed to study participation
- Patients with vascular claudication
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
- Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
- Patients with medical history of spinal surgery within the past 3 months
- Patients who were treated with invasive interventions such as Korean medicine treatment, injections, physical therapy, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
- Pregnant patients or patients planning pregnancy
- Patients with serious psychological disorders
- Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
- Patients unable to fill out study participation consent form
- Patients deemed unsuitable for study participation as assessed by the researchers
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lumbar stenosis group Chuna manual medicine Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Chuna manual medicine Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Other intervention(s) Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Herbal medicine Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Acupuncture Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Acupuncture Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Bee venom pharmacopuncture Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Pharmacopuncture Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Cupping Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Electroacupuncture Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar stenosis group Electroacupuncture Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Pharmacopuncture Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Herbal medicine Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Other intervention(s) Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Bee venom pharmacopuncture Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Lumbar spondylolisthesis group Cupping Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
- Primary Outcome Measures
Name Time Method Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain Change from baseline to 4 months Change from higher score at baseline out of low back pain or radiating leg pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome)
- Secondary Outcome Measures
Name Time Method Numeric rating scale (NRS) of radiating leg pain Baseline, observation at least once a week for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years Radiating leg pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)
Visual analogue scale (VAS) of radiating leg pain Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Radiating leg pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)
Maximum walking distance (average of the past 3 days) Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Walking ability. Average maximum walking distance during the past 3 days as recalled at each timepoint defined in Time Frame. Total score range: 0 (worse outcome) to no maximum limit (better outcome)
Oswestry Disability Index (ODI) Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)
EQ-VAS Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
SF-36 [Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years] The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Numeric rating scale (NRS) of low back pain Baseline, observation at least once a week for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years Low back pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)
Visual analogue scale (VAS) of low back pain Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Low back pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)
Pain-free walking distance (average of the past 3 days) Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Walking ability. Average pain-free walking distance during the past 3 days as recalled at each timepoint defined in Time Frame. Total score range: 0 (worse outcome) to no maximum limit (better outcome)
Zurich Claudication Questionnaire Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Claudication questionnaire. There are 12 questions for all patients, and a further 6 questions to measure treatment outcomes for those who have received treatment. The The Zurich Claudication Questionnaire consists of three subscales: (1) Symptom severity scale (items 1-7) which are subdivided into a pain domain (items 1-4) and a neuroischemic domain (items 5-7)\]: The possible range of each item score is 1 to 5. (2) Physical function scale (items 8-12): The possible range of each item score is 1 to 4. (3) Patient satisfaction with treatment scale (questions 13-18): The possible range of each item score is 1 to 4. The result is expressed as a percentage of the maximum possible score. Total score range: 0% (better outcome) to 100% (worse outcome)
EuroQol 5-dimensions 5-levels (EQ-5D-5L) Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Health-related quality of life questionnaire. Total score range: 11111 (better outcome) to 55555 (worse outcome)
Adverse reaction Baseline, every visit for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years Safety
Patient Global Impression of Change (PGIC) 8, 16, 20, 24 weeks, 1, 3, 5 years Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)
Physical examination Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Lumbar physical examination
Use of other intervention(s) Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years Use of any other additional intervention(s) other than the integrative Korean medicine treatment administered by the attending physician (start date of treatment, end date of treatment, name of treatment, number of treatment sessions received, and other comments)
Trial Locations
- Locations (1)
Jaseng Medical Foundation
🇰🇷Seoul, Korea, Republic of