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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02630381
Other study ID # NL40580.078.12
Secondary ID
Status Completed
Phase Phase 2
First received December 7, 2015
Last updated October 11, 2017
Start date May 18, 2015
Est. completion date September 19, 2016

Study information

Verified date October 2017
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 19, 2016
Est. primary completion date September 19, 2016
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UMC Utrecht

Outcome

Type Measure Description Time frame Safety issue
Primary Bone mineral density will be assessed with the use of repeated dual energy X-ray absorptiometry measurements 12 weeks
Primary Bone mineral density will be assessed with the use of repeated dual energy X-ray 6 weeks
Secondary Pain on the VAS scale day before and first week after treatment
Secondary Patient's side effects and complications on a questionnaire 12 weeks
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