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

Primary Purpose

Osteopenia or Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Pulsed Electromagnetic Field
Exercise Program
Pulsed High Laser Therapy
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia or Osteoporosis focused on measuring T-scores of ≤1.5

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Al Noor Specialized Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Electromagnetic and Exercise Group

Laser and Exercise Group

Exercise Group

Arm 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

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 Program Exercise program to facilitate bone health

Outcomes

Primary Outcome Measures

Change from baseline Bone Mineral Density at 3 months
Bone Mineral Density was assessed by the DEXA in the lumbar spine, proximal femur and forearm region in g/cm2.
Change from baseline Vitamin D levels at 3 months
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
Alkaline Phosphatase was estimated colorimetric end point and kinetic using fully automated analyzer Advia Centaur, according to enclosed pamphlet.

Secondary Outcome Measures

Change from baseline Osteocalcin at 3 months
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
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.

Full Information

First Posted
August 26, 2021
Last Updated
August 26, 2021
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05029440
Brief Title
Pulsed Electromagnetic Field Versus Pulsed High Intensity Laser in the of Osteoprosis
Official Title
Effect of Full-Body Pulsed Electromagnetic Field Versus Pulsed High Intensity Laser Therapy in the Treatment of Patients With Osteopenia or Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia or Osteoporosis
Keywords
T-scores of ≤1.5

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electromagnetic and Exercise Group
Arm Type
Experimental
Arm 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
Arm Title
Laser and Exercise Group
Arm Type
Active Comparator
Arm 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
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Exercise Program Exercise program to facilitate bone health
Intervention Type
Other
Intervention Name(s)
Pulsed Electromagnetic Field
Intervention Description
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
Intervention Name(s)
Exercise Program
Intervention Description
The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.
Intervention Type
Other
Intervention Name(s)
Pulsed High Laser Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline Bone Mineral Density at 3 months
Description
Bone Mineral Density was assessed by the DEXA in the lumbar spine, proximal femur and forearm region in g/cm2.
Time Frame
Baseline and 3 months post-intervention
Title
Change from baseline Vitamin D levels at 3 months
Description
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.
Time Frame
Baseline and 3 months post-intervention
Title
Change from baseline Alkaline Phosphatase at 3 months
Description
Alkaline Phosphatase was estimated colorimetric end point and kinetic using fully automated analyzer Advia Centaur, according to enclosed pamphlet.
Time Frame
Baseline and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline Osteocalcin at 3 months
Description
Ostocalcin is a predictive marker for osteoprosis and bone fracture. Serum Osteocalcin was measured in serum samples using an ELISA Kits.
Time Frame
Baseline and 3 months post-intervention
Title
Change from baseline Parathyroid Hormone at 3 months
Description
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.
Time Frame
Baseline and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamekh M Elshamy, Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Noor Specialized Hospital
City
Mecca
ZIP/Postal Code
715
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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