Shock Wave Therapy for Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Rationale: Osteoporotic fractures are associated with high morbidity and mortality. This is
      why prevention of these fractures is important. The investigators have shown in animal
      studies that a single treatment with unfocused extracorporeal shock wave therapy leads to
      highly increased bone mass and improved biomechanical properties. Unfocused extracorporeal
      shock wave therapy could have important implications for the prevention of osteoporotic
      fractures.

      Objective: To assess the effect of unfocused extracorporeal shock wave therapy on bone mass.

      Study design: A clinical pilot study. Study population: Twelve female patients are eligible
      if they are undergoing elective surgery of the lower extremity or elective spinal surgery
      under general anesthesia in the investigators hospital.

      Intervention: When the patient is under general anaesthesia he/she will receive 3000
      unfocused extracorporeal shock waves (energy flux density 0.3mJ/mm2) to one distal forearm.
      The contra lateral forearm will not be treated and serves as a control.

      Main study parameters/endpoints:

      The investigators will examine the effect on bone mass with the use of repeated dual energy
      X-ray absorptiometry measurements. These results are necessary to calculate the number of
      patients that are needed for larger studies. Furthermore, the investigators will assess
      patient's discomfort.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: General anaesthesia is performed during treatment and pain after the procedure
      will be evaluated using pain scales and, if necessary pain medication will be prescribed by
      the orthopaedic surgeon. The dual energy X-ray absorptiometry-scans and X-rays will cause
      very low radiation exposure to the patient.
    


Intervention name(s): Unfocused extracoporeal shock wave therapy
Intervention type(s): Device
Intervention description(s): Shock waves are acoustical pulses that are characterized by high amplitude (~500 bar) and short rise time (~20 ns), which are followed by a longer low-magnitude negative wave (~-100 bar). Extracorporeal shock waves are widely used to disintegrate kidney stones, which is called lithotripsy. In orthopedics, shock wave therapy, called orthotripsy, is used safely in a variety of musculoskeletal disorders like non unions, osteonecrosis of the hip, Achilles and patellar tendinopathy, lateral epicondylitis of the elbow and fasciitis plantaris.
Until recently extracorporeal shock wave therapy for musculoskeletal disorders was applied with a focused character, in which the waves converge in a focal point similar to lithotripsy. For the prevention of fractures in osteoporosis a focused character is not preferable because large skeletal regions have to be treated, so unfocused shock waves have been developed.
Other intervention name(s): Extracorporeal shock waves; Extracorporeal shock wave therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: high-energy shock waves