Shockwave Therapy for Acute Low Back Pain

Not Applicable

Completed

• Conditions: Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
• Interventions: Device: shockwave therapy; Device: placebo shockwave therapy

• Registration Number: NCT02253771
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-31
• Study First Submitted QC: 2014-09-28
• Study First Posted: 2014-10-01
• Study Start: 2017-11-08
• Primary Completion: 2018-09-13
• Study Completion: 2019-01-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shockwave therapy	shockwave therapy	shockwave therapy
Placebo treatment	placebo shockwave therapy	sham shockwave therapy by an identically looking device without any function

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (Oswestry disability Index)	day 0; 7; 14; 21, after 6 and 8 weeks.	Oswestry disability Index
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

Trial Locations

Locations (1)

Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie; 🇩🇪 Münster, NRW, Germany