This study aims to investigate the therapeutic effects of electromagnetic fields (EMFs) on the healing period of fresh Tibia fracture. Inclusion criteria are male or female patients (15 to 65 years old) with fresh tibia fracture, with no concurrent application of physical exercise or physiotherapy. Exclusion criteria are presence of cardiovascular diseases, pace-maker, osteoporosis induced fracture, use of opioid drugs and addiction treatment medications, abnormal orthopedic and musculoskeletal conditions. Forty patients are randomly divided into three groups (each 15 cases): one control group and two intervention groups. The intervention group 1 receives daily low frequency pulsed EMFs (20 Hz, 4 mT, 20 min) for 5 consecutive days per week and 4 consecutive weeks. Group 2 receives Calcium ion cyclotron resonance exposure (76.6 Hz, 0.1 mT, 20 min) for 5 consecutive days per week and 4 consecutive weeks. The patients receive interventions within 4 days after fixation surgery. The primary outcome is fracture healing period, defined as forming 3 cortices in the radiographic image. The secondary outcome is bone mineral density in the tibial bone which is measured by dual energy X-ray technique.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042324635N3
Registration date:2016-11-22, 1395/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-22, 1395/09/02
Registrant information
Name
Ali Yadollahpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 1208
Email address
yadollahpour-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2016-05-01, 1395/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Therapeutic Effects of Pulsed Electromagnetic Fields on Bone healing period in patients with fresh tibia fracture
Public title
Therapeutic Effects of Pulsed Electromagnetic Fields on Healing Period of Bone Fracture:
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: fresh fracture of tibia; no use of medications; no use of physical exercise and physiotherapy. Exclusion criteria: cardiovascular diseases, patients with pace-maker, fracture because of osteoporosis, Opioids and addiction treatment medications, abnormal orthopedic; and musculoskeletal conditions.
Age
From 15 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Physics department, Scholl of Medicine, Ahvaz Jundishapur University of Medical Physics, Ahv
Street address
Golestan Blv., Research deputy , Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Postal code
6135715794
Approval date
2015-10-10, 1394/07/18
Ethics committee reference number
IR.AJUMS.REC.1394.718
Health conditions studied
1
Description of health condition studied
fresh tibia fracture
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia
Primary outcomes
1
Description
Fracture healing period
Timepoint
30 and 45 days after start of intervention
Method of measurement
Using X-ray radiography- formation of 3 cortices
Secondary outcomes
1
Description
bone mineral density
Timepoint
pre and post intervantion
Method of measurement
dual energy X-ray (Dexa)
Intervention groups
1
Description
In the control group, patients are matched by gender and age with the intervention groups and do not receive stimulation.
Category
Treatment - Devices
2
Description
Group 1 intervention: patients receive
low frequency pulsed electromagnetic fields (25 Hz, 4 mT, daily 20 min, 5 consecutive days per week, 4 consecutive weeks).
Category
Treatment - Devices
3
Description
Group 2 intervention: Patients receive Calcium ion cyclotron resonance exposure (76.6 Hz, 0.1 mT, 20 min daily, for 5 consecutive days per week and 4 consecutive weeks.