Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
Conditions
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.
Interventions
DEVICEshockwave therapy
Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
DEVICEplacebo shockwave therapy
sham shockwave therapy by an identically looking device without any function
Sponsors
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain, using visual analogue scale (VAS) | Day 0; 7; 14; 21; 28, after 6 and 8 weeks. | Change in pain, using visual analogue scale (VAS 1-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in other clinical questionnaires (Oswestry disability Index) | day 0; 7; 14; 21, after 6 and 8 weeks. | Oswestry disability Index |
| Change in other clinical questionnaires (Beck's depression scale) | day 0; 7; 14; 21, after 6 and 8 weeks. | Beck's depression scale |
| Change in other clinical questionnaires (EQ-5D) | day 0; 7; 14; 21, after 6 and 8 weeks. | EQ-5D |
| Change in other clinical questionnaires (Roland-Morris-Score) | day 0; 7; 14; 21, after 6 and 8 weeks. | Roland-Morris-Score |
Countries
Germany
Outcome results
None listed