Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis

Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis. A Randomized Placebo-controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia or Osteoprosis
• Intervention / Treatment: Other: Pulsed Electromagnetic Field (PEMF); Other: Exercise Program; Other: Placebo PEMF

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca, Saudi Arabia
    • Al Noor Specialized Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I; Group one received PEMF and exercise (PEMF+EX)	Other: Pulsed Electromagnetic Field (PEMF); PEMF was administered to the whole body using a 1.8×0.6m mat; Other: Exercise Program; Exercise program to facilitate bone health
PLACEBO_COMPARATOR: Group II; Group two received placebo PEMF and exercise (PPEMF+EX)	Other: Exercise Program; Exercise program to facilitate bone health; Other: Placebo PEMF; Patients received placebo PEMF
ACTIVE_COMPARATOR: Group III; Group three will be treated by PEMF alone (PEMF)	Other: Pulsed Electromagnetic Field (PEMF); PEMF was administered to the whole body using a 1.8×0.6m mat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Bone Mineral Density at 3 months	Bone Mineral Density will assessed by the DEXA in the lumbar spine, proximal femur and forearm region in g/cm2.	Baseline and 3 months, and 6 months post-intervention
Change from baseline Vitamin D levels at 3 months	Vitamin D test is the most accurate way to measure how much vitamin D is in the body. Vitamin D in serum will measured as a standard procedure at the Department of Clinical Chemistry.	Baseline and 3 months, and 6 months post-intervention
Change from baseline Alkaline Phosphatase at 3 months	Alkaline Phosphatase will be estimated colorimetric end point and kinetic using fully automated analyzer Advia Centaur, according to enclosed pamphlet.	Baseline and 3 months, and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Osteocalcin at 3 months	Ostocalcin is a predictive marker for osteoprosis and bone fracture. Serum Osteocalcin will measured in serum samples using an ELISA Kits.	Baseline and 3 months, and 6 months post-intervention
Change from baseline Parathyroid Hormone at 3 months	Parathyroid hormones (PTH) will measurement chemiluminescence immunoassays [QuiCkIntraOperativeTM intact PTH. The assay will performed on the Immuno- automated analyzer (DPC) at the Department of Clinical Chemistry at Um ALQURA University, Faculty of Applied Medical Science. The Roche intact-PTH test will be assayed on an Elecsys-1010 immunoassay analyzer (Roche Diagnostics) with its "Stat-function.	Baseline and 3 months, and 6 months post-intervention

Collaborators and Investigators

• Sponsor: Umm Al-Qura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2020
• Primary Completion (ACTUAL): August 25, 2020
• Study Completion (ACTUAL): August 25, 2020

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (ACTUAL): October 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: T-scores of ≤ ˗1.5
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: Umm Al-Qura Uni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No