Shockwave Therapy for Acute Low Back Pain

University Hospital Muenster

Status: Completed

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

Treatments: Device: shockwave therapy; Device: placebo shockwave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02253771

Orth-001

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups, including a placebo group

shockwave therapy

Experimental group

Description:

shockwave therapy

Treatment:

Device: shockwave therapy

Placebo treatment

Placebo Comparator group

Description:

sham shockwave therapy by an identically looking device without any function

Treatment:

Device: placebo shockwave therapy