Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
- Sponsor
- University Hospital Muenster
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Change in pain, using visual analogue scale (VAS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy.
60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. They are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. Additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The clinical outcome will be primarily measured by pain intensity using a visual analogue scale. Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale, Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the difference in change of scores between groups using one-way t-test.
Investigators
Niklas Deventer
Dr. med. Niklas Deventer
University Hospital Muenster
Eligibility Criteria
Inclusion Criteria
- •low back pain for less than 3 months
Exclusion Criteria
- •Patients with relevant leg pain
- •Patients with spine operations in the past
- •neurologic symptoms
- •scoliosis with Cobb angle \> 10°
- •Patients experienced in shock wave therapy
- •Patientes with ongoing therapy with blood diluting drugs such as phenprocumon
- •Patients with osteoporosis
- •Patients with back pain after trauma
- •Patients with infective diseases or tumor diseases
- •Patients with relevant psychological diseases
Outcomes
Primary Outcomes
Change in pain, using visual analogue scale (VAS)
Time Frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Change in pain, using visual analogue scale (VAS 1-10)
Secondary Outcomes
- Change in other clinical questionnaires (Beck's depression scale)(day 0; 7; 14; 21, after 6 and 8 weeks.)
- Change in other clinical questionnaires (Oswestry disability Index)(day 0; 7; 14; 21, after 6 and 8 weeks.)
- Change in other clinical questionnaires (EQ-5D)(day 0; 7; 14; 21, after 6 and 8 weeks.)
- Change in other clinical questionnaires (Roland-Morris-Score)(day 0; 7; 14; 21, after 6 and 8 weeks.)