MedDataX Logo

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

NCT ID: NCT04608162

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteopenia or Osteoprosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I

Group one received PEMF and exercise (PEMF+EX)

Group Type ACTIVE_COMPARATOR

Pulsed Electromagnetic Field (PEMF)

Intervention Type OTHER

PEMF was administered to the whole body using a 1.8×0.6m mat

Exercise Program

Intervention Type OTHER

Exercise program to facilitate bone health

Group II

Group two received placebo PEMF and exercise (PPEMF+EX)

Group Type PLACEBO_COMPARATOR

Exercise Program

Intervention Type OTHER

Exercise program to facilitate bone health

Placebo PEMF

Intervention Type OTHER

Patients received placebo PEMF

Group III

Group three will be treated by PEMF alone (PEMF)

Group Type ACTIVE_COMPARATOR

Pulsed Electromagnetic Field (PEMF)

Intervention Type OTHER

PEMF was administered to the whole body using a 1.8×0.6m mat

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulsed Electromagnetic Field (PEMF)

PEMF was administered to the whole body using a 1.8×0.6m mat

Intervention Type OTHER

Exercise Program

Exercise program to facilitate bone health

Intervention Type OTHER

Placebo PEMF

Patients received placebo PEMF

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Umm Al-Qura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shamekh Mohamed El-Shamy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shamekh M El-Shamy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al Noor Specialized Hospital

Mecca, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Umm Al-Qura Uni

Identifier Type: -

Identifier Source: org_study_id