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Pulsed Electromagnetic Field Versus Pulsed High Intensity Laser in the of Osteoprosis

NCT ID: NCT05029440

Last Updated: 2021-08-31

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-05-25

Brief Summary

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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 comparison with pulsed high laser therapy.

Detailed Description

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Objectives: This randomized controlled study aims to investigate theEffect of Full-Body Pulsed Electromagnetic Field versus Pulsed High Intensity Laser Therapy in the Treatment of Men with Osteopenia or Osteoporosis Methods: Ninty 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 HILT and exercise (HILT+EX) and group three will be treated by exercise alone (Ex). 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

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Osteopenia or Osteoporosis

Keywords

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T-scores of ≤1.5

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Electromagnetic and Exercise Group

Pulsed Electromagnetic Field (PEMF) PEMF was administered to the whole body using a 1.8×0.6m mat Exercise Program Exercise program to facilitate bone health

Group Type EXPERIMENTAL

Pulsed Electromagnetic Field

Intervention Type OTHER

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.

Exercise Program

Intervention Type OTHER

The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.

Laser and Exercise Group

Pulsed High Intensity Laser Therapy (HILT) HILT was administered to lumbar region and femoral head using Exercise Program Exercise program to facilitate bone health

Group Type ACTIVE_COMPARATOR

Exercise Program

Intervention Type OTHER

The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.

Pulsed High Laser Therapy

Intervention Type OTHER

High Laser was delivered with a total dose of energy of 3000 J was delivered in two treatment phases. The initial phase was performed with fast manual scanning at 510, 610, and 710 mJ/cm2 in three successive subphases and 500 J in each subphase for a total of 1500 J. The final phase was the same as the initial phase except that the scanning was slow. The average area for the upper thigh or lower back was 200 cm2 with an average fluency of 15 J/cm2 and the application time for each area was 18 min. HILT was applied using a HIRO 3 device (ASA, Arcugnano, Vicenza, Italy).

Exercise Group

Exercise Program Exercise program to facilitate bone health

Group Type ACTIVE_COMPARATOR

Exercise Program

Intervention Type OTHER

The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.

Interventions

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Pulsed Electromagnetic Field

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.

Intervention Type OTHER

Exercise Program

The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.

Intervention Type OTHER

Pulsed High Laser Therapy

High Laser was delivered with a total dose of energy of 3000 J was delivered in two treatment phases. The initial phase was performed with fast manual scanning at 510, 610, and 710 mJ/cm2 in three successive subphases and 500 J in each subphase for a total of 1500 J. The final phase was the same as the initial phase except that the scanning was slow. The average area for the upper thigh or lower back was 200 cm2 with an average fluency of 15 J/cm2 and the application time for each area was 18 min. HILT was applied using a HIRO 3 device (ASA, Arcugnano, Vicenza, Italy).

Intervention Type OTHER

Eligibility Criteria

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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

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Umm Al-Qura University

OTHER

Sponsor Role lead

Responsible Party

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Shamekh Mohamed El-Shamy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shamekh M Elshamy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Al Noor Specialized Hospital

Mecca, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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Umm AlQura U

Identifier Type: -

Identifier Source: org_study_id