Shockwave Therapy for Acute Low Back Pain

NCT02253771 | Completed

• 1 other identifier: Orth-001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in other clinical questionnaires (Oswestry disability Index)

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

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

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

• Change in other clinical questionnaires (EQ-5D)

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

• Change in other clinical questionnaires (Roland-Morris-Score)

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

Study Arms (2)

shockwave therapy

EXPERIMENTAL

shockwave therapy

Device: shockwave therapy

Placebo treatment

PLACEBO COMPARATOR

sham shockwave therapy by an identically looking device without any function

Device: placebo shockwave therapy

Interventions

shockwave therapy DEVICE

Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week

Also known as: EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.), CE Certificate: 0124

shockwave therapy

placebo shockwave therapy DEVICE

sham shockwave therapy by an identically looking device without any function

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain for less than 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (2)

• 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.

  PMID: 18588702 BACKGROUND

• 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.

  PMID: 21482199 BACKGROUND

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Niklas Deventer, Dr. med.

  Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie

  PRINCIPAL INVESTIGATOR

• Tobias Schulte, Prof. Dr. med.

  Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum

  STUDY DIRECTOR

• Tobias Lange, Dr. med., MBA

  Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Niklas Deventer

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: October 1, 2014
• Study Start: November 8, 2017
• Primary Completion: September 13, 2018
• Study Completion: January 15, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

DE (1)