Clinical full-scale study for the comparative effectiveness and cost-effectiveness of Chuna manual therapy for low back pai
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002329
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 194
1) Non-acute low back pain patients (with pain duration of 3 weeks or longer) with average Numeric Rating Scale (NRS) =5 during the past week
2) Patients aged 19 years or older and 70 years or younger
3) Patients who have agreed to trial participation and provided written informed consent
1) Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
2) Patients who are suspected of fracture according to the researcher's clinical judgment
3) Patients with spinal surgery history within 3 months
4) Patients with other chronic disease(s) which may interfere with treatment effect or interpretation of outcome (e.g. chronic renal failure)
5) Patients with progressive neurologic deficit or severe neurologic symptoms such as cauda equina syndrome
6) Patients with inner fixation or stabilization device applied through spinal surgery
7) Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
8) Patients who have received Chuna manual therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or invasive treatments such as acupuncture or injections within the past week
9) Pregnant patients, breastfeeding patients or patients with plans of pregnancy
10) Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
11) Patients who received surgery, procedures or medication treatment that may interfere with study results during the intervention period (7 weeks) without consulting with the attending physician
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umeric Rating Scale (NRS) of low back pain
- Secondary Outcome Measures
Name Time Method umeric Rating Scale (NRS) of radiating leg pain ;Oswestry disability index (ODI);Patient Global Impression of Change (PGIC);Lumbar range of motion (ROM);EuroQol-5 Dimension (EQ-5D) ;Health Utility Index ? (HUI-?);EuroQol-Visual Analogue Scale (EQ-VAS) ;Economic evaluation data;Adverse events;Vital signs