Shockwave Therapy for Acute Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial

Conditions
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Acute Low Back Pain (Low Back Pain for Less Than 3 Months)

Intervention / Treatment
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* Device: shockwave therapy
* Device: placebo shockwave therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shockwave therapy<br>shockwave therapy | Device: shockwave therapy<br>* Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week<br>* Other names: CE Certificate: 0124;|
| Placebo Comparator: Placebo treatment<br>sham shockwave therapy by an identically looking device without any function | Device: placebo shockwave therapy<br>* sham shockwave therapy by an identically looking device without any function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain, using visual analogue scale (VAS) | Change in pain, using visual analogue scale (VAS 1-10) | Day 0; 7; 14; 21; 28, after 6 and 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other clinical questionnaires (Oswestry disability Index) | Oswestry disability Index | day 0; 7; 14; 21, after 6 and 8 weeks. | 
| Change in other clinical questionnaires (Beck's depression scale) | Beck's depression scale | day 0; 7; 14; 21, after 6 and 8 weeks. | 
| Change in other clinical questionnaires (EQ-5D) | EQ-5D | day 0; 7; 14; 21, after 6 and 8 weeks. | 
| Change in other clinical questionnaires (Roland-Morris-Score) | Roland-Morris-Score | day 0; 7; 14; 21, after 6 and 8 weeks. |