Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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 (hereafter, "C-E drug therapy") is statistically significantly more effective than either rESWT or C-E drug therapy alone in the treatment of chronic non-specific low back pain.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborator: Ludwig-Maximilians - University of Munich
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Eperisone; Parasympatholytics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.