Shockwave Therapy for Acute Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
• Intervention / Treatment: Device: shockwave therapy; Device: placebo shockwave therapy

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48149
      • Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: shockwave therapy	Device: shockwave therapy; Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week; Other Names: EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.); CE Certificate: 0124
Placebo Comparator: Placebo treatment; sham shockwave therapy by an identically looking device without any function	Device: placebo shockwave therapy; sham shockwave therapy by an identically looking device without any function

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Niklas Deventer, Dr. med., Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie; Study Director: Tobias Schulte, Prof. Dr. med., Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum; Principal Investigator: Tobias Lange, Dr. med., MBA, Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum

Publications and helpful links

General Publications

• Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97.
• Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): September 13, 2018
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: August 31, 2014
• First Submitted That Met QC Criteria: September 28, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Orth-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No