NCT02253771

Shockwave Therapy for Acute Low Back Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	shockwave therapy	Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
DEVICE	placebo shockwave therapy	sham shockwave therapy by an identically looking device without any function

Timeline

• Start date: 2017-11-08
• Primary completion: 2018-09-13
• Completion: 2019-01-15
• First posted: 2014-10-01
• Last updated: 2021-02-02

Locations

1 site across 1 country: Germany