Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis

NCT04608162 | Completed DMC

• 1 other identifier: Umm Al-Qura Uni
• Study Type: interventional
• Target: 120
• 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 long term effect on several parameters.

Conditions

Osteopenia or Osteoprosis

Keywords

T-scores of ≤ ˗1.5

Outcome Measures

Primary Outcomes (3)

• Change from baseline Bone Mineral Density at 3 months

  Bone Mineral Density will assessed by the DEXA in the lumbar spine, proximal femur and forearm region in g/cm2.

  Baseline and 3 months, and 6 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 will measured as a standard procedure at the Department of Clinical Chemistry.

  Baseline and 3 months, and 6 months post-intervention

• Change from baseline Alkaline Phosphatase at 3 months

  Alkaline Phosphatase will be estimated colorimetric end point and kinetic using fully automated analyzer Advia Centaur, according to enclosed pamphlet.

  Baseline and 3 months, and 6 months post-intervention

Secondary Outcomes (2)

• Change from baseline Osteocalcin at 3 months

  Baseline and 3 months, and 6 months post-intervention

• Change from baseline Parathyroid Hormone at 3 months

  Baseline and 3 months, and 6 months post-intervention

Study Arms (3)

Group I

ACTIVE COMPARATOR

Group one received PEMF and exercise (PEMF+EX)

Other: Pulsed Electromagnetic Field (PEMF); Other: Exercise Program

Group II

PLACEBO COMPARATOR

Group two received placebo PEMF and exercise (PPEMF+EX)

Other: Exercise Program; Other: Placebo PEMF

Group III

ACTIVE COMPARATOR

Group three will be treated by PEMF alone (PEMF)

Other: Pulsed Electromagnetic Field (PEMF)

Interventions

Pulsed Electromagnetic Field (PEMF) OTHER

PEMF was administered to the whole body using a 1.8×0.6m mat

Group I; Group III

Exercise Program OTHER

Exercise program to facilitate bone health

Group I; Group II

Placebo PEMF OTHER

Patients received placebo PEMF

Group II

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, Saudi Arabia

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

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 El-Shamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: May 25, 2020
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)