Status:
COMPLETED
Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Conditions:
Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) in combination with the non-steroidal anti-inflammatory drug Celecoxib and the antispasmodic drug Eperisone (herea...
Detailed Description
Non-specific low back pain is defined as low back pain not attributable to a recognizable, known specific pathology (e.g., infection, tumour, osteoporosis, fracture, structural deformity, inflammatory...
Eligibility Criteria
Inclusion
- Adults (both male and female) with non-specific low back pain for more than three months.
- Age range: between 18 and 80 years.
- Willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient.
- Chronic non-specific low back pain clinically diagnosed as repeated lumbar sourness and swelling pain or a chronic progressive process, accompanied by (i) X-ray examination to exclude lumbar vertebrate fractures, spondylolysis, spondylolisthesis and severe osteoporosis, and/or (ii) MRI with normal signal or low nucleus pulposus signal.
- No contraindications for rESWT.
Exclusion
- Children and teenagers below the age of 18.
- Elderly aged \>80 years old
- No willingness of the patient to participate in the study, and/or written informed consent not signed and not personally dated by the patient.
- Previous spinal fracture or spinal surgery.
- Protrusion of a lumbar intervertebral disk, ankylosing spondylitis, scoliosis, lumbar spondylolisthesis and lumbar spondylolysis.
- Systemic disorders and psychiatric disorders.
- Contraindications of C-E drug treatment (treatment of patients allergy to celecoxib, eperisone or sulfonamides, patients with gastrointestinal bleeding or bleeding history, patients with renal dysfunction, patients with severe heart failure, and lactating women).
- Contraindications of rESWT ( pregnant patients, patients with blood-clotting disorders \[including local thrombosis\], patients treated with oral anticoagulants, patients with local tumors, patients with local bacterial and/or viral infections \[including lumbar vertebral tuberculosis\], and patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session \[if applicable\]).
- Participation in any other clinical trial in the time period of 12 weeks before potential inclusion in the proposed study.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03337607
Start Date
November 13 2017
End Date
August 1 2019
Last Update
January 8 2025
Active Locations (1)
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1
Department of Pain Medicine, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003