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Clinical research of Comparative Effectiveness and Cost-effectiveness of Chuna manual therapy for Low back pai

Not Applicable
Completed
Conditions
Diseases of the musculo-skeletal system and connective tissue
Registration Number
KCT0001850
Lead Sponsor
Pusan National University Korean Medicine Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria

1) Non-acute low back pain patients (with pain duration of 3 weeks or longer) requiring medical management
2) Patients with average Numeric Rating Scale (NRS) =5 during the past week
3) Patients aged 19 years or older and 70 years or younger
4) Patients who have agreed to trial participation and provided written informed consent

Exclusion Criteria

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 with spinal surgery history within 3 months
3) Patients with other chronic disease(s) which may interfere with treatment effect or interpretation of outcome (e.g. chronic renal failure)
4) Patients with progressive neurologic deficit or severe neurologic symptoms
5) Patients with inner fixation or stabilization device applied through spinal surgery
6) Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
7) Patients who have received Chuna manual therapy or medicine which may influence pain levels such as nonsteroidal anti-inflammatory drugs (NSAIDs) within the past week
8) Pregnant patients or patients with plans of pregnancy
9) Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umeric Rating Scale (NRS) of low back pain
Secondary Outcome Measures
NameTimeMethod
umeric Rating Scale (NRS) of radiating leg pain;Oswestry disability index (ODI);Patient Global Impression of Change (PGIC);Credibility and Expectancy Questionnaire;Lumbar range of motion (ROM);EuroQol-5 Dimension (EQ-5D);Health Utility Index ? (HUI-?);Economic evaluation data;Adverse events
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