Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis
Condition: Osteopenia or Osteoprosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      Osteoporosis is the most prevalent metabolic bone disease. Although osteoporosis is widely
      considered to be much more prevalent in women approximately 39% of new osteoporotic fractures
      estimated to have occurred worldwide in 2000 were in men. A number of studies investigate the
      effect of physical therapy modalities in treatment of osteoporosis. The use of pulsed
      electromagnetic field (PEMF) represents an attractive alternative for osteoporosis.

      Previous studies suggested that pulsed electromagnetic field could be beneficial for increase
      bone mineral density in osteoporotic patients, but there is a lack of knowledge about the
      long term effect on several parameters.
    

Detailed description: 
      Objectives: This randomized controlled study aims to investigate the long term effect of
      pulsed electromagnetic field (PEMF) on bone mineral density (BMD) and bone markers; also to
      be used as treatment intervention of osteopenia or osteoporosis through studying the effect
      of low intensity, low frequency, single pulsed electromagnetic fields. Methods: One hundred
      and twenty male patients with osteopenia or osteoporosis will participate in this study,
      their age ranges between 30-60 years. They have BMD T-scores ≤ - 1.5. All patients will be
      randomized into one of three groups. Group one received PEMF and exercise (PEMF+EX), group
      two received placebo PEMF and exercise (PPEMF+EX) and group three will be treated by PEMF
      alone (PEMF). The exercise training program will include treadmill and aerobic exercises for
      hip and upper limb will be performed for 50 minutes.PEMF was administered to the whole body
      for PEMF groups using a 1.8×0.6m mat 30 minutes/day, 3 times/week for 3 months. Dual-energy
      X-ray absorptiometry (DEXA) will assess Bone mineral density BMD (g/cm2), bone mineral
      content (BMC), T-Score and Z-Score at the lumbar spine, proximal femur and forearm region,
      bone markers (25-hydroxy Vit D , Total, undercarboxylated Ostocalcin, Parathyroid Hormone,
      Total and Ionized calcium and Alkaline Phosphatase (ALP), also will be measured. The
      assessment will be done at baseline, after treatment (12 weeks) and after 6 months as follow
      up. The data will be analyzed using repeated measures Analysis of variance (ANOVA) for
      comparison between pre-treatment and post treatment measurement intervals. One-way ANOVA is
      used to compare between each treatment interval in treatment groups at pre-test and post
      treatment measurement intervals. The level of significance is set at 0.05 for all tests.
    

Intervention name(s): Pulsed Electromagnetic Field (PEMF); Exercise Program; Placebo PEMF
Intervention type(s): Other; Other; Other
Intervention description(s): PEMF was administered to the whole body using a 1.8×0.6m mat; Exercise program to facilitate bone health; Patients received placebo PEMF
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T-scores of ≤ ˗1.5