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

Not Applicable

Completed

• Conditions: Osteopenia or Osteoporosis
• Interventions: Other: Pulsed Electromagnetic Field; Other: Exercise Program; Other: Pulsed High Laser Therapy

• Registration Number: NCT05029440
• Lead Sponsor: Umm Al-Qura University

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 comparison with pulsed high laser therapy.

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-25
• Status Verified: 2021-08
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Last Update Submitted: 2021-08-26
• Study First Posted: 2021-08-31
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline Osteocalcin at 3 months	Baseline and 3 months post-intervention	Ostocalcin is a predictive marker for osteoprosis and bone fracture. Serum Osteocalcin was measured in serum samples using an ELISA Kits.
Change from baseline Parathyroid Hormone at 3 months	Baseline and 3 months post-intervention	Parathyroid hormones (PTH) was measurement chemiluminescence immunoassays \[QuiCkIntraOperativeTM intact PTH. The assay was 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 was assayed on an Elecsys-1010 immunoassay analyzer (Roche Diagnostics) with its "Stat-function.

Trial Locations

Locations (1)

Al Noor Specialized Hospital; 🇸🇦 Mecca, Saudi Arabia