Evaluating the effect of magnetic field therapy on pain and function in individuals with grade II ankle sprain
Design
A randomized, double-blinded, sham controlled clinical trial on 50 patients. Randomization will be performed using an online block randomization tool (www.sealedenvelope.com).
Settings and conduct
The study population includes patients with grade 2 ankle sprains who refer to Shohadaye Tajrish Hospital, Tehran. Patients are then randomly divided into two groups, sham and intervention.
Both groups receive standard treatment including RICE (Rest, Ice, Compression and Elevation) for 10 days, followed by standard physiotherapy program. Standard physiotherapy program includes Diathermy with Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS), for 10 sessions, performed every other day. Diathermy was performed with a therapeutic US device for 10 min to the relevant ankle at a dose of 1 W/cm2. The TENS device with two electrodes surrounding tendon was performed for 30 min at a frequency of 100 Hz for current application.
Intervention group concurrently receives magnet therapy for 10 sessions, performed every other day. Magnetic field is applied to relevant ankle with the PEMF device for 25 min at 25 G intensity at a frequency of 50 Hz. The device is set to 0 when applying to patients in sham group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with lateral ankle sprain grade II
Exclusion criteria: No history of ankle surgery, ankle osteoarthritis, and ankle deformities
Intervention groups
Sham group receives standard treatment including RICE (Rest, Ice, Compression and Elevation) for 10 days, followed by standard physiotherapy protocol.
Intervention group receives standard treatment along with magnet therapy.
Main outcome variables
Ankle pain by visual analogue scale
Ankle function by American Orthopedic Foot and Ankle Society Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046714N2
Registration date:2023-12-30, 1402/10/09
Registration timing:prospective
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Hooshmand Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4409 8132
Email address
hooshmand.z1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-06, 1402/10/16
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnetic field therapy on pain and function in individuals with grade II lateral ankle sprain, a randomized clinical trial
Public title
Effect of magnet therapy in ankle sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years and under 65 years
Grade 2 (moderate) ligament injury based on clinical and imaging criteria
absence of ankle fracture
presented within the first 72 hours after the injury
Exclusion criteria:
Pregnancy
Breastfeeding
Those who intend to become pregnant
Radiologic evidence of fracture or damage to syndesmosis at presentation
history of previous sprain or fracture in each of ankles
History of surgery and active infection at the site of injury
History of peripheral vascular diseases
Foot deformities
Knee or ankle osteoarthritis
Rheumatoid Arthritis
Ankylosing spondylitis
Diabetes Mellitus
Neurological disorders
Psychiatric disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using an online block randomization tool (www.sealedenvelope.com), with a variable block size of 2 or 4, and stratified based on age (≥40 or < 40 years).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are informed about study, but will be blinded to randomization. All patients will receive standard therapy.
Evaluation of the outcomes will be performed by an orthopedic surgeon who is unaware of patients’ randomization.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2023-12-10, 1402/09/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.549
Health conditions studied
1
Description of health condition studied
lateral ankle sprain
ICD-10 code
S93.40
ICD-10 code description
Sprain of unspecified ligament of ankle
Primary outcomes
1
Description
Determination of ankle pain with VAS
Timepoint
At first visit, one month after injury, three months after injury
Method of measurement
Questionnaire (Visual Analogue Scale)
2
Description
Determination of ankle function with AOFAS
Timepoint
At first visit, one month after injury, three months after injury
Method of measurement
Questionnaire (American Orthopedic Foot and Ankle Score)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in this group receive standard treatment including RICE (Rest, Ice, Compression and Elevation) for 10 days, followed by standard physiotherapy program. Standard physiotherapy program includes Diathermy with Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS), for 10 sessions, performed every other day. Patients concurrently receives magnet therapy for 10 sessions, performed every other day. The device is set to 0 when applying to patients in control group.
Category
Treatment - Other
2
Description
Intervention group: Patients in this group receive standard treatment similar to control group. This group concurrently receives magnet therapy for 10 sessions, performed every other day. Magnetic field is applied to relevant ankle with the PEMF device for 25 min at 25 G intensity at a frequency of 50 Hz.