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Completed

NCT Number: NCT02253771

Shockwave Therapy for Acute Low Back Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shockwave therapy

Device

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 shockwave therapy

Device

sham shockwave therapy by an identically looking device without any function

Primary outcomes

  1. Change in pain, using visual analogue scale (VAS)

    Time frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.

    Change in pain, using visual analogue scale (VAS 1-10)

Secondary outcomes

  1. Change in other clinical questionnaires (Oswestry disability Index)

    Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.

    Oswestry disability Index

  2. Change in other clinical questionnaires (Beck's depression scale)

    Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.

    Beck's depression scale

  3. Change in other clinical questionnaires (EQ-5D)

    Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.

    EQ-5D

  4. Change in other clinical questionnaires (Roland-Morris-Score)

    Time frame: day 0; 7; 14; 21, after 6 and 8 weeks.

    Roland-Morris-Score

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 1, 2014
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.