Electromagnetic Treatment For Bone Loss After Forearm Fracture
Feasibility and Dosing Study of Bone Density Changes With and Without PEMF Following Immobilization of the Forearm
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
A PHASE1/PHASE2 clinical study on Bone Disease, Metabolic and Osteopenia, this trial is completed. The trial is conducted by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and has accumulated 5 data snapshots since 2003. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)The long-range goal of this research is to develop a new and supplementary local treatment for osteoporosis to reduce the risk of fracture in susceptible individuals. PEMF is a noninvasive method to magnetically introduce a small amount of electrical current to a specific bone region to stimulate bone formation. PEMFs have been used for many years to treat nonunited fractures and enhance spine fusion healing and have been found to improve bone density in animal models of osteoporosis. Such a noninvasive intervention applied to the hip or spine, which are especially associated with high morbidity and mortality in aging individuals, could have a significant national health care impact. If effective for the treatment of bone loss, PEMF technology may be effective in treating osteoporosis. The primary objective of this pilot study is to determine the feasibility of using PEMFs to reverse or reduce bone loss that occurs with disuse of the forearm after fracture or surgery and to determine the effect of daily treatment duration on efficacy. Eighty patients who have recently undergone immobilization after hand surgery or after lower forearm fracture will be enrolled in this study. Participants will be randomized to either the PEMF group or a control...
The long-range goal of this research is to develop a new and supplementary local treatment for osteoporosis to reduce the risk of fracture in susceptible individuals. PEMF is a noninvasive method to magnetically introduce a small amount of electrical current to a specific bone region to stimulate bone formation. PEMFs have been used for many years to treat nonunited fractures and enhance spine fusion healing and have been found to improve bone density in animal models of osteoporosis. Such a noninvasive intervention applied to the hip or spine, which are especially associated with high morbidity and mortality in aging individuals, could have a significant national health care impact.
If effective for the treatment of bone loss, PEMF technology may be effective in treating osteoporosis. The primary objective of this pilot study is to determine the feasibility of using PEMFs to reverse or reduce bone loss that occurs with disuse of the forearm after fracture or surgery and to determine the effect of daily treatment duration on efficacy.
Eighty patients who have recently undergone immobilization after hand surgery or after lower forearm fracture will be enrolled in this study. Participants will be randomized to either the PEMF group or a control group. PEMFs will be administered by means of a magnetic coil transducer placed over the treatment site for 1, 2, or 4 hrs/day for 8 weeks, beginning 6 weeks after the initial injury or surgery. A self-contained, battery-powered PEMF coil transducer already FDA-approved for fracture healing in the forearm will be used. Participants in the control group will receive inactive but otherwise identical units and treatment times. Measurements of bone density will be made using DEXA (dual energy x-ray absorptiometry) and pQCT (peripheral quantitative computer tomography) and compared to baseline. DEXA and pQCT provide planar and cross-sectional x-ray densitometry to determine forearm bone changes. Bone densities (global, cortical, and trabecular), bone cross-sectional structural geometry, and calculated strength index will be measured and compared to baseline values.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
First recorded
Nov 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
For direct contact, visit the study record on ClinicalTrials.gov .