Clinical full-scale study for the comparative effectiveness and cost-effectiveness of Chuna manual therapy for low back pain

Clinical research of Comparative Effectiveness and Cost-effectiveness of Chuna manual therapy for non-acute Low back pain : Multi-center Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002329

Enrollment

194

Registered

2017-05-16

Start date

2017-03-20

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery, Others : Usual care group Usual care will be limited to physical therapy and back pain education in this study. Usual care physical therapy will be provided with reference to a list

or higher will be assessed as the last visit of Week 4 and the last visit of Week 6 which marks the end of treatment) will be administered over a period of 6 weeks. The frequency of treatment sessions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Numeric Rating Scale (NRS) of low back pain	—

Secondary

Measure	Time frame
Numeric 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	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Cheul Shin

Pusan National University Korean Medicine Hospital

drshinbc@gmail.com+82-55-360-5945

Outcome results