Shock Wave Therapy for Osteoporosis (BOEST)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Unfocused extracoporeal shock wave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring high-energy shock waves
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Shock wave arm
Contra-lateral arm
Arm Description
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.
The distal radius and/or wrist that did not receive UESWT will not be treated
Outcomes
Primary Outcome Measures
Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements
Bone mineral density will be assessed with the use of repeated dual energy X-ray
Secondary Outcome Measures
Pain on the VAS scale
Patient's side effects and complications on a questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02630381
Brief Title
Shock Wave Therapy for Osteoporosis
Acronym
BOEST
Official Title
Treatment of Osteoporosis With Unfocused Extracorporeal Shock Wave Therapy: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 18, 2015 (Actual)
Primary Completion Date
September 19, 2016 (Actual)
Study Completion Date
September 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
high-energy shock waves
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shock wave arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Contra-lateral arm
Arm Type
No Intervention
Arm Description
The distal radius and/or wrist that did not receive UESWT will not be treated
Intervention Type
Device
Intervention Name(s)
Unfocused extracoporeal shock wave therapy
Other Intervention Name(s)
Extracorporeal shock waves, Extracorporeal shock wave therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements
Time Frame
12 weeks
Title
Bone mineral density will be assessed with the use of repeated dual energy X-ray
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pain on the VAS scale
Time Frame
day before and first week after treatment
Title
Patient's side effects and complications on a questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
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Shock Wave Therapy for Osteoporosis
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