Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain - Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low-back Pain (cLBP)
- Sponsor
- Ruhr University of Bochum
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- change in Numeric Rating Scale (NRS)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
Analysis of the effectiveness of radial shock wave therapy as part of a multimodal pain therapy in the inpatient setting. Different therapy protocols are compared in previously non-operated and in previously operated patients.
Detailed Description
Radial shock wave therapy is an approved pain therapy procedure that has been used in various degenerative orthopedic diseases for years. There are a few studies on the subject of chronic back pain. Some studies suggest that this method can be used sensibly. A direct comparison of different therapy protocols has not been carried out so far. As part of inpatient multimodal pain therapy (including infiltration and physiotherapy) in patients with chronic lumbar back pain with or without degenerative surgery in the area of the lumbar spine radial shock wave therapy after a specific protocol is used. Only inpatients will be admitted to the study. All patients are informed verbally and give their written consent. Comprehensive patient information will be provided before the start of the study, handed out and explained as part of the information discussion. There will be 2 groups ((a) patients with previous degenerative surgery in the area of the lumbar spine, (b) patients without such a pre-operation) examined each with 4 sub-groups depending of the different therapy protocols.
Investigators
Dr. med. Tobias Lange, MBA
Principal Investigator
Ruhr University of Bochum
Eligibility Criteria
Inclusion Criteria
- •chronic lumbar back pain of min 3 months duration
Exclusion Criteria
- •radicular pain of higher intensity than chronic low back pain (cLBP)
- •new neurologic deficits
- •anticoagulant therapy
- •new trauma to the lumbar spine
- •spine bacterial infection
- •spine tumor
- •pregnancy
- •coagulation disorder
- •previous infiltration to the lumbar spine within 6 weeks prior to study inclusion
- •fibromyalgia
Outcomes
Primary Outcomes
change in Numeric Rating Scale (NRS)
Time Frame: pre-intervention, 2 weeks, 1 month, 3 months, 6 months
Pain intensity measured by Numeric Rating Scale (NRS) - 11-point scale / min. 0 (better outcome) / max. 10 (worse outcome)
Secondary Outcomes
- change in Oswestry Disability Index (ODI)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Patient Health Questionnaire-9 (PHQ-9)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Perseverative Thinking Questionnaire (PTQ)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Patient Specific Functional Scale (PSFS)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Questionnaire Subgroups for Targeted Treatment (STarT-G)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in European Quality of Life 5 Dimensions (EQ5D)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Pain Self-Efficacy Questionnaire (PSEQ)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in The World Health Organisation- Five Well-Being Index (WHO-5)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)
- change in Big Five Inventory-SocioOeconomicPanel (BFI-S)(pre-intervention, 2 weeks, 1 month, 3 months, 6 months)