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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

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.


Condition or disease Intervention/treatment Phase
Osteoporosis Device: Unfocused extracoporeal shock wave therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Osteoporosis With Unfocused Extracorporeal Shock Wave Therapy: Pilot Study
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : September 19, 2016
Actual Study Completion Date : September 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis Shock

Arm Intervention/treatment
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.
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

No Intervention: Contra-lateral arm
The distal radius and/or wrist that did not receive UESWT will not be treated



Primary Outcome Measures :
  1. Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements [ Time Frame: 12 weeks ]
  2. Bone mineral density will be assessed with the use of repeated dual energy X-ray [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Pain on the VAS scale [ Time Frame: day before and first week after treatment ]
  2. Patient's side effects and complications on a questionnaire [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Marianne Koolen, Drs, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02630381    
Other Study ID Numbers: NL40580.078.12
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by Marianne Koolen, UMC Utrecht:
high-energy shock waves
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases