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

Umm Al-Qura University

Status: Completed

Conditions: Osteopenia or Osteoporosis

Treatments: Other: Exercise Program; Other: Pulsed High Laser Therapy; Other: Pulsed Electromagnetic Field

Study type: Interventional

Funder types: Other

Identifiers

NCT05029440

Umm AlQura U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Electromagnetic and Exercise Group

Experimental group

Description:

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

Treatment:

Other: Pulsed Electromagnetic Field

Other: Exercise Program

Laser and Exercise Group

Active Comparator group

Description:

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

Treatment:

Other: Pulsed High Laser Therapy

Other: Exercise Program

Exercise Group

Active Comparator group

Description:

Exercise Program Exercise program to facilitate bone health

Treatment:

Other: Exercise Program