NCT05029440

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

Effect of Full-Body Pulsed Electromagnetic Field Versus Pulsed High Intensity Laser Therapy in the Treatment of Patients With Osteopenia or Osteoporosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Umm Al-Qura University · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteopenia or Osteoporosis

Interventions

Type	Name	Description
OTHER	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.
OTHER	Exercise Program	The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.
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).

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-15
• Completion: 2021-05-25
• First posted: 2021-08-31
• Last updated: 2021-08-31

Locations

1 site across 1 country: Saudi Arabia