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

NCT05029440 | Completed DMC

• 1 other identifier: Umm AlQura U
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia or Osteoporosis

Keywords

T-scores of ≤1.5

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 3 months post-intervention

• 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.

  Baseline and 3 months post-intervention

• 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.

  Baseline and 3 months post-intervention

Secondary Outcomes (2)

• Change from baseline Osteocalcin at 3 months

  Baseline and 3 months post-intervention

• Change from baseline Parathyroid Hormone at 3 months

  Baseline and 3 months post-intervention

Study Arms (3)

Electromagnetic and Exercise Group

EXPERIMENTAL

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

Other: Pulsed Electromagnetic Field; Other: Exercise Program

Laser and Exercise Group

ACTIVE COMPARATOR

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

Other: Exercise Program; Other: Pulsed High Laser Therapy

Exercise Group

ACTIVE COMPARATOR

Exercise Program Exercise program to facilitate bone health

Other: Exercise Program

Interventions

Pulsed Electromagnetic Field 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.

Electromagnetic and Exercise Group

Exercise Program OTHER

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

Electromagnetic and Exercise Group; Exercise Group; Laser and Exercise Group

Pulsed High Laser Therapy 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).

Laser and Exercise Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Al Noor Specialized Hospital

Mecca, 715, Saudi Arabia

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shamekh M Elshamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 31, 2021
• Study Start: February 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 25, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)