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Shock Wave Therapy for Osteoporosis (BOEST)

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ClinicalTrials.gov Identifier: NCT02630381
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Marianne Koolen, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE December 15, 2015
Last Update Posted Date October 12, 2017
Actual Study Start Date  ICMJE May 18, 2015
Actual Primary Completion Date September 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
  • Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements [ Time Frame: 12 weeks ]
  • Bone mineral density will be assessed with the use of repeated dual energy X-ray [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2015)
  • Pain on the VAS scale [ Time Frame: day before and first week after treatment ]
  • Patient's side effects and complications on a questionnaire [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shock Wave Therapy for Osteoporosis
Official Title  ICMJE Treatment of Osteoporosis With Unfocused Extracorporeal Shock Wave Therapy: Pilot Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE Device: Unfocused extracoporeal shock wave therapy

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 Names:
  • Extracorporeal shock waves
  • Extracorporeal shock wave therapy
Study Arms  ICMJE
  • Experimental: Shock wave arm
    Unfocused extracorporeal shock wave therapy will be applied on the distal radius on one site when the patient is receiving general anaesthesia for surgery on the lower extremity or spine.
    Intervention: Device: Unfocused extracoporeal shock wave therapy
  • No Intervention: Contra-lateral arm
    The distal radius and/or wrist that did not receive UESWT will not be treated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 19, 2016
Actual Primary Completion Date September 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female sex, age 50-80 years, normal dietary intake inclusive calcium and/or milk products and willing to participate

Exclusion Criteria:

  • skin disease, systemic corticosteroid use, known systemic disease that interacts with bone (eg. rheumatoid arthritis, multiple myeloma, hyper(para)thyroidism, Paget's disease or Cushing's disease) or a previous wrist fracture
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02630381
Other Study ID Numbers  ICMJE NL40580.078.12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marianne Koolen, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account UMC Utrecht
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP