Clinical trial NCT04608162: Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis
Official title: Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis. A Randomized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia or Osteoprosis
Keywords: T-scores of ≤ ˗1.5
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a T-scores of ≤ ˗1.5, all patients received the same medical treatment for osteoporosis and the same average blood glucose level, sufficient ability to understand the nature and potential risks of the study.

Exclusion Criteria:

* Diabetes mellitus, ischemic heart disease, arrhythmia, uncontrolled thyroid disease, cardiac pacemaker, tuberculosis, neuropsychiatric disorders (dementia, cerebrovascular disease, alcohol abuse, severe depression, panic disorder, bipolar disorder, or psychosis), and malignancy.

Primary outcomes:
measure: Change from baseline Bone Mineral Density at 3 months
timeFrame: Baseline and 3 months, and 6 months post-intervention
measure: Change from baseline Vitamin D levels at 3 months
timeFrame: Baseline and 3 months, and 6 months post-intervention
measure: Change from baseline Alkaline Phosphatase at 3 months
timeFrame: Baseline and 3 months, and 6 months post-intervention
Secondary outcomes:
measure: Change from baseline Osteocalcin at 3 months
timeFrame: Baseline and 3 months, and 6 months post-intervention
measure: Change from baseline Parathyroid Hormone at 3 months
timeFrame: Baseline and 3 months, and 6 months post-intervention
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Al Noor Specialized Hospital
Study officials:
affiliation: Professor
name: Shamekh M El-Shamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: