Clinical trial NCT02253771: Shockwave Therapy for Acute Low Back Pain
Official title: Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in pain, using visual analogue scale (VAS)
timeFrame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
Secondary outcomes:
measure: Change in other clinical questionnaires (Oswestry disability Index)
timeFrame: day 0; 7; 14; 21, after 6 and 8 weeks.
measure: Change in other clinical questionnaires (Beck's depression scale)
timeFrame: day 0; 7; 14; 21, after 6 and 8 weeks.
measure: Change in other clinical questionnaires (EQ-5D)
timeFrame: day 0; 7; 14; 21, after 6 and 8 weeks.
measure: Change in other clinical questionnaires (Roland-Morris-Score)
timeFrame: day 0; 7; 14; 21, after 6 and 8 weeks.
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
state: NRW
Study officials:
affiliation: Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
name: Niklas Deventer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
name: Tobias Schulte, Prof. Dr. med.
role: STUDY_DIRECTOR
affiliation: Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
name: Tobias Lange, Dr. med., MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.