Protocol summary

Study aim
The purpose of this research is to investigate and compare three types of therapeutic intervention, pulsed electromagnetic field, therapeutic exercise and combined exercise therapy and pulsed electromagnetic field on bone mineral density, bone metabolism and quality of life in patients with osteoporosis
Design
Single-blined Randomized control trial with parallel groups and 12-week follow-up. Randomization will be done by selecting the sealed envelope. The sample size will be 12 people in each group according to the similar studies and using G-power software.
Settings and conduct
After the initial evaluation, the patients who meet the inclusion criteria will be randomly assigned to one of the three groups of pulsed electromagnetic field, therapeutic exercise, combined treatment of pulsed electromagnetic field and therapeutic exercise. Twice a week for 12 weeks and the evaluation will be done after the end of 12 weeks and also after the 12-week follow-up.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: women aged 55 and 68 with a diagnosis of osteoporosis by a rheumatologist, 6 months have passed since menopause, have no history of ovariectomy or fracture due to osteoporosis.Exclusion criteria: - a history of using drugs affecting bone metabolism, or sedatives, or doing physical therapy and hormone therapy in the last 6 months - unwillingness to Continuation of the treatment or change in the sample conditions that cause the loss of one of the entry conditions
Intervention groups
Pulsed Electromagnetic field 24 intervention sessions (2 times a week) - Exercisetherapy group 24 intervention sessions (2 times a week) - combined treatment of Pulsed Electromagnetic field and Exercise therapy 24 sessions (2 times a week)
Main outcome variables
Bone Mineral Density-Bone Metabolism-Quality of Life

General information

Reason for update
Acronym
PEMF
IRCT registration information
IRCT registration number: IRCT20221202056687N1
Registration date: 2022-12-15, 1401/09/24
Registration timing: prospective

Last update: 2022-12-15, 1401/09/24
Update count: 0
Registration date
2022-12-15, 1401/09/24
Registrant information
Name
Fatemeh Sangtarah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
f-sangtarash@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Application of Pulsed Electromagnetic Field and Therapeutic Exercise on Bone Mineral Density and Metabolism, and Quality of Life in Postmenopausal Osteoporotic Women
Public title
"Effect of Pulsed Electromagnetic Field and Exercise Therapy in treatment of Osteoporosis"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women at the age of 55-68, having reached menopause at least 5 year before the study. A body mass index of 22-30 T-score for the hip or lumbar spine -2.5 SD or less. do not have a history of overioectomy syrgery Do not have a history of osteoporosis fracture
Exclusion criteria:
Participating in sports regularly for at least one year before starting the study (regular exercise means at least 30 minutes a day and 3 days a week) Taking drugs that affect bone metabolism, except for daily calcium and vitamin D and weekly alendronite tablets, which will be prescribed by the rheumatology consultant of the study with the same dose for all participants. The presence of any medical problem affecting the person's movement (diabetes - diseases of the vestibular system - uncorrected vision or hearing disorders - neurological diseases A history of surgery in the spine and pelvis and the use of tools to fix it or a history of surgery in the lower limbs • History of hormone therapy in the last 6 months A history of having cardiovascular diseases, such as uncontrolled blood pressure, which will be considered as an exclusion criterion for groups that will do exercise therapy Using physiotherapy modalities effective on bone metabolism, such as using WBV, LPL, PEMF modalities in the last 6 month Using tranquilizers (Tranquillizer) in both minor classifications (anti-anxiety, diazepam, oxazepam, alprazolam, etc.) and major (antipsychotic drugs such as haloperidol, phenotazines, fluphenazine, etc.) in three last month Unwillingness of the samples to continue the treatment and not participating regularly in the treatment program A change in sample conditions that would result in missing one of the inclusion criteria
Age
From 55 years old to 68 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign patients, sealed envelopes containing the words "pulsed electromagnetic field" or "therapeutic exercise" or "combination of pulsed electromagnetic field + therapeutic exercise" will be prepared. After flipping the cards, the clinic secretary clinic will randomly select one of the envelopes for each patient. The use of this method guarantees randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single-blinded study, which means that an experience physiotherapist do the intervention and another physiotherapist will do the evaluations. As a result, the evaluator will not know which group the patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Faculty of Rehabilitation Sciences, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.TUMS.FNM.REC.1401.126

Health conditions studied

1

Description of health condition studied
Osteoporosis
ICD-10 code
M81.0
ICD-10 code description
Age-related osteoporosis without current pathological fracture

Primary outcomes

1

Description
Bone mineral Density
Timepoint
At the beginning of the intervention and 12 weeks after the end of the intervention
Method of measurement
The use of X-Ray absorption method with dual energy DXA will be measured using the HOLOGENIC QDR1000 devic

2

Description
Bone Turnover markers-bone specific alkalin phosphatase(BSALP)
Timepoint
Before the start of the intervention - immediately after the end of the intervention - after a 12-week follow-up from the end of the intervention
Method of measurement
Blood test and examination of blood sample with the laboratory method of ELISA

3

Description
Bone Turnover markers-N- terminal telopeptide of type 1 collagen
Timepoint
Before the start of the intervention - immediately after the end of the intervention - after a 12-week follow-up from the end of the intervention
Method of measurement
Blood test and examination of blood sample with the laboratory method of ELISA

4

Description
Quality of life
Timepoint
Before the start of the intervention - immediately after the end of the intervention - after a 12-week follow-up from the end of the intervention
Method of measurement
Quality Of Life Questionnaire Of European Foundation for Osteoporosis

Secondary outcomes

1

Description
Thoracic kyphosis
Timepoint
before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention
Method of measurement
Photogrammetry method

2

Description
lumbar lordosis
Timepoint
before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention
Method of measurement
Photogrammetry method

3

Description
Functional Balance
Timepoint
before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention
Method of measurement
Functional balance study with Timed Up and Go (TUG), Unilateral Stance Test(USL)

4

Description
Muscle Strenght
Timepoint
before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention
Method of measurement
Using micro manual muscle tester

5

Description
fear of falling
Timepoint
before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention
Method of measurement
persian version of Falls Efficacy Scale-International Questionnaire

Intervention groups

1

Description
Intervention group: Pulse Electro Magnetic field
Category
Rehabilitation

2

Description
Intervention group: Exercise therapy
Category
Rehabilitation

3

Description
Intervention group: Pulsed Electromagnetic field+Exercise therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
رaliasr Hospital, Zanjan
Full name of responsible person
Alireza Sadeghi
Street address
Ansariye
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3373 9011
Email
valiasr@zums.ac.ir

2

Recruitment center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar fotohi
Street address
Keshavarz Blvd., corner of Qods St., Central Organization ofTehran University of Medical Sciences, 6th floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Enghelab St., Faculty of Rehabilitation Sciences, Department of Physiotherapy
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
shadmehr@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sangtarash
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Enghelbal St., Faculty of Rehabilitation Sciences, Department of Physiotherapy
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5
Email
f-sangtarash@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sangtarsh
Position
university student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Enghelab St., Faculty of Rehabilitation Sciences, Department of Physiotherapy
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5
Email
f-sangtarash@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If needed by the researchers and their request, the raw data of the research and Its analysis will be provided to researchers
When the data will become available and for how long
After the publication of the articles resulting from the research
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data is only available to other researchers to study and review treatment results Placed
From where data/document is obtainable
By sending an email to the corresponding author
What processes are involved for a request to access data/document
Send an email to the responsible author and request the document
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