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IRCT20160808029264N14 IRCT 2022-01-16 Semnan University of Medical Sciences The Effect of Magnet on Tendon thickness in Tennis Elbow Ultrasonographic Assessment of Pulsed Electromagnetic Field Stimulation (PEMFS) Effect on Tendon thickness in Tennis Elbow 2022-04-04 anticipated 30 Complete https://irct.ir/trial/60958 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Tennis Elbow. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are no more information
public Sahel aliannejadi
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
Semnan Iran (Islamic Republic of) 3513135111 +98 23 3344 1022 sahel.aliannejad@gmail.com Semnan University of Medical Sciences scientific Dr. Rasool Bagheri
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
Semnan Iran (Islamic Republic of) 3513135111 +98 23 3344 1022 rasool.bagheri@ymail.com Semnan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Both 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 M77.10 Lateral epicondylitis, unspecified elbow Rehabilitation Rehabilitation 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 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 Tendon thickness. Timepoint: The first session, last session. Method of measurement: Ultrasound device. Pain. Timepoint: The first session, last session. Method of measurement: Visual Analogue Scale. Disability. Timepoint: The first session, last session. Method of measurement: Persian version of Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire. Range of Motion. Timepoint: The first session, last session. Method of measurement: Goniometry. Semnan University of Medical Sciences Approved 2021-12-29 Ethics Comitee of Semnan University of Medical Sciences Basij Blvd., Semnan., Semnan Province Semnan Semnan Iran (Islamic Republic of)