Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain (NCT03337607) | Clinical Trial Compass
CompletedNot Applicable
Radial Extracorporeal Shock Wave Therapy for Chronic Non-specific Low Back Pain
China150 participantsStarted 2017-11-13
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Change in Pain Self-Efficacy Questionnaire (PSEQ) score (Nicholas, 1989; paper presented at the annual conference of the British Psychological Society, St. Andrews, 1989)
Timeframe: Change from baseline PSEQ score at 12 weeks
Trial details
NCT IDNCT03337607
SponsorFirst Affiliated Hospital of Zhejiang University