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Ultrasonographic Assessment of Pulsed Electromagnetic Field Stimulation (PEMFS) Effect on Tendon thickness in Tennis Elbow

Protocol summary

Study aim
Determining effect of adding Pulsed Electromagnetic field stimulation to routine physiotherapy on Common extensor tendon thickness, pain and disability in Tennis elbow patients
Design
clinical trial with a control group, with parallel groups, Single-blind, randomized, permuted block randomization was used for randomization
Settings and conduct
Tennis elbow patients enter the study voluntarily in Semnan University of Medical Sciences, will be randomly divided into two groups of control and intervention; Common Extensor Tendon (CET) thickness, pain and disability will be measured. intervention group receives 10 sessions including routine physiotherapy and Pulsed Electromagnetic Field Stimulation (PEMFS), control group receives 10 sessions including routine physiotherapy and sham PEMFS. After 10 session CET thickness, pain and disability of patients will be measured and compared
Participants/Inclusion and exclusion criteria
18-45 years tennis elbow patients with lateral elbow and forearm pain more than 6 weeks, tenderness in the origin of Extensor carpi radialis brevis, increased tenderness of dorsiflexion of wrist against resistance and of forearm supination will be included in the study. people with accompanying painful conditions, which may confuse the clinical picture such as upper extremity fracture, inflammatory arthritic conditions, carpal tunnel syndrome, thoracic outlet syndrome, cervical radiculopathy, and tendon ruptures or accompanying medial epicondylitis and people who has contraindications for Pulsed electromagnetic field stimulation such as tuberculosis, pregnancy, cardiac pacemaker, and malignancy will be excluded
Intervention groups
1)Active group: 10 sessions of routine physiotherapy and Electromagnetic Field Stimulation (PEMFS), 2) Control group: 10 sessions of routine physiotherapy and Sham PEMFS
Main outcome variables
Common Extensor Tendon thickness, pain, disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160808029264N14
Registration date: 2022-01-16, 1400/10/26
Registration timing: prospective

Last update: 2022-01-16, 1400/10/26
Update count: 0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasonographic Assessment of Pulsed Electromagnetic Field Stimulation (PEMFS) Effect on Tendon thickness in Tennis Elbow
Public title
The Effect of Magnet on Tendon thickness in Tennis Elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
lateral elbow and forearm pain that lasted for more than 6 weeks tenderness in the origin of the extensor carpi radialis brevis muscle increased tenderness of dorsiflexion of the wrist against resistance and of forearm supination Differential diagnosisfrom cervical problems and radial tunnel syndrome age between 18 - 45 years
Exclusion criteria:
accompanying painful conditions, which may confuse the clinical picture such as upper extremity fracture, inflammatory arthritic conditions, carpal tunnel syndrome, thoracic outlet syndrome, cervical radiculopathy, and tendon ruptures accompanying medial epicondylitis contraindications for Pulsed Electromagnetic Field Stimulation such as tuberculosis, pregnancy, cardiac pacemaker, and malignancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization: 4 blocks are used for randomization. The intervention groups are called A and the control group is called B. Different 4 blocks including A, B are defined in different permutations. We will have 15 blocks of 4. Each block is assigned a number from 1 to 6. Using a random number generator, the blocks are selected from 6 selected blocks, respectively. Eligible individuals are assigned to either A or B in each block (from left to right) in a predetermined order.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not be aware of their group in control group ,sham Pulsed Electromagnetic Field Stimulation will be used Their elbows going to be positioned the same way as with the Group 1 patients in the same applicator. However, the electric current producer will be connected to another solenoid applicator (small solenoid). The patient will sense the same visual and auditory stimuli like the patient taking the active therapy, but no exposure to the real magnetic field
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd., Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
99951-35198
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
IR.SEMUMS.REC.1400.240

Health conditions studied

1

Description of health condition studied
Tennis Elbow
ICD-10 code
M77.10
ICD-10 code description
Lateral epicondylitis, unspecified elbow

Primary outcomes

1

Description
Tendon thickness
Timepoint
The first session, last session
Method of measurement
Ultrasound device

Secondary outcomes

1

Description
Pain
Timepoint
The first session, last session
Method of measurement
Visual Analogue Scale

2

Description
Disability
Timepoint
The first session, last session
Method of measurement
Persian version of Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire

3

Description
Range of Motion
Timepoint
The first session, last session
Method of measurement
Goniometry

Intervention groups

1

Description
Intervention group: 10 session of physiotherapy, three sessions per week, each session consist of below: 1)Pulsed electromagnetic field stimulation (PEMFS) : The injured elbow of each patient will be put in the middle portion of a big circle solenoid applicator in prone position. The dose and application time will be selected according to the recommendations of the manufacturer. The total dose application is 6 mT/session. This dose is going to be completed by applying the PEMF in a frequency of 25 Hz and a frequency of 4.6 Hz, consecutively. A therapy session lasting for 30 min. 2)routine physiotherapy: Transcutaneous electrical nerve stimulation (TENS) , Low frequency TENS: 5 KHz modulated by 2 Hz frequency mode on acupuncture points , Infrared (IR) for 12 minutes on lateral aspect of elbow. Stretching , The Proprioceptive neuromuscular facilitation (PNF) stretching model was used with contraction for 10 seconds, short relaxation and then stretching for 15- 20 seconds of the forearm extensors (and the antagonist flexors subsequently), to be performed feeling the tightness, but below the pain threshold. Eccentric exercise: patient sitting on a chair, support the forearm on the armrest or on an adjacent table in prone position. The eccentric exercise is to lower the weight by flexing the wrist of the affected arm downwards and to lift it back again with the unaffected arm in three sets of 15 repetitions, in total 45 weight lowering manoeuvres. Ultrasound therapy: continuous ultrasonic waves of 1.5 MHz frequency and 1 W/cm2 power. The patients in the sitting position, and an acoustic gel containing no pharmacological active substance will be applied. Ultrasound will be applied to the lateral epicondyle in circular movements
Category
Rehabilitation

2

Description
Control group: Intervention group: 10 session of physiotherapy, three sessions per week, each session consist of below: 1)Sham PEMFS: Their elbows will be positioned the same way as with the Group 1 patients in the same applicator. However, the electric current producer will be connected to another solenoid applicator (small solenoid). The patient will sense the same visual and auditory stimuli like the patient taking the active therapy, but not exposed to the real magnetic field. 2)routine physiotherapy: Transcutaneous electrical nerve stimulation (TENS) , Low frequency TENS: 5 KHz modulated by 2 Hz frequency mode on acupuncture points , Infrared (IR) for 12 minutes on lateral aspect of elbow. Stretching , The Proprioceptive neuromuscular facilitation (PNF) stretching model was used with contraction for 10 seconds, short relaxation and then stretching for 15- 20 seconds of the forearm extensors (and the antagonist flexors subsequently), to be performed feeling the tightness, but below the pain threshold. Eccentric exercise: patient sitting on a chair, support the forearm on the armrest or on an adjacent table in prone position. The eccentric exercise is to lower the weight by flexing the wrist of the affected arm downwards and to lift it back again with the unaffected arm in three sets of 15 repetitions, in total 45 weight lowering manoeuvres. Ultrasound therapy: continuous ultrasonic waves of 1.5 MHz frequency and 1 W/cm2 power. The patients in the sitting position, and an acoustic gel containing no pharmacological active substance will be applied. Ultrasound will be applied to the lateral epicondyle in circular movements
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center,. Semnan University of Medical Scinces., Semnan., Iran.
Full name of responsible person
Dr Rasool Bagheri
Street address
Basij Blvd.,Semnan., Semnan Province
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid MirMohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Sahel aliannejadi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Email
sahel.aliannejad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Email
rasool.bagheri@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rasool bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
Semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Email
rasool.bagheri@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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