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IRCT20140408017177N2 IRCT 2023-01-01 Shiraz University of Medical Sciences The effects of addition of transcranial direct current stimulation to exercise in patients with lateral elbow pain The effects of addition of transcranial direct current stimulation to therapeutic exercise on pain, functional disability and grip strength in patients with tennis elbow 2023-01-25 anticipated 40 Complete https://irct.ir/trial/67009 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomly assigned to one of the two study groups by block randomization method using random allocation software in 10 blocks of 4. Allocation concealment will be done by using sequentially numbered, opaque sealed envelopes, Blinding description: In this study, treating therapist is not blind to the stimulation condition. Outcome assessor differs from the treating therapist and is blinded to group allocation. There will be two groups of participants in this study and both groups will receive the same exercises but different stimulation conditions. First group will receive active transcranial direct current stimulation and second group will receive sham transcranial direct current stimulation. They will be aware that they could receive either sham or active stimulation but they will be blinded to stimulation condition they receive during treatment sessions. The data analyst who is different from the treating therapist will be blinded to group allocation. N/A Tennis elbow. Intervention 1: active transcranial direct current stimulation group: 1) progressive eccentric exercises of the wrist extensors / 3 sets of 10 repetitions. 2) Extensor carpi radialis brevis muscle stretch/ 6 repetitions / 3 times before and 3 times after eccentric exercises with 30 seconds of rest between each repetition / 30 to 45 seconds each time. 3) Anodal transcranial direct current stimulation with an intensity of 2 mA for 20 minutes. Intervention 2: sham transcranial direct current stimulation group: 1) progressive eccentric exercises of the wrist extensors / 3 sets of 10 repetitions. 2) Extensor carpi radialis brevis muscle stretch/ 6 repetitions / 3 times before and 3 times after eccentric exercises with 30 seconds of rest between each repetition / 30 to 45 seconds each time. 3) sham transcranial direct current stimulation with an intensity of 2 mA for 30 seconds. 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 is no further information
public Iman Rezaei
School or Rehabilitation, Sheikh Abivardi 1 street, Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 irezaei@sums.ac.ir Shiraz University of Medical Sciences scientific Iman Rezaei
School of Rehabilitation, Abiverdi1, Chamran Blvd.
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 irezaei@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) unilateral lateral elbow pain for 6 weeks to 1 year average pain intensity of 3 or more on visual analog scale during the last week age between 30 to 55 years a score of 33 or more on the patient-rated tennis elbow evaluation questionnaire pain over the lateral humeral epicondyle provoked by at least two of the following four tests:1) palpation of the external epicondyle, 2) Resisted wrist extension (Thomsen/Cozen's test), 3) Resistance extension of fingers (Maudsley test), 4) Passive stretching of the extensor muscle group (Mills test) 30 years 55 years Both history of local trauma, surgery, physiotherapy treatment or corticosteroid injection in the lateral epicondyle within the last 3 month cervical radiculopathy systemic diseases such as diabetes and rheumatological disorders heart problems history of stroke intracranial surgery, migraine, brain cancer, mental or neurological disorder taking drugs that alter neuronal activity any metal implants, including intracranial electrodes, surgical clips, cochlear implants or pacemakers, or other implanted electronic devices pregnancy or breastfeeding balance disorder or dizziness active infection or scalp or skin condition (e.g., psoriasis or eczema) a head injury that resulted in a loss of consciousness that required further investigation (e.g., a brain scan) seizure epilepsy or a history of epilepsy adverse effects to previous transcranial direct current stimulation or other brain stimulation techniques Covid-19 infection during the study or during one month before the start of the study carpal tunnel syndrome fibromyalgia M77.1 Lateral epicondylitis Rehabilitation Rehabilitation active transcranial direct current stimulation group: 1) progressive eccentric exercises of the wrist extensors / 3 sets of 10 repetitions. 2) Extensor carpi radialis brevis muscle stretch/ 6 repetitions / 3 times before and 3 times after eccentric exercises with 30 seconds of rest between each repetition / 30 to 45 seconds each time. 3) Anodal transcranial direct current stimulation with an intensity of 2 mA for 20 minutes sham transcranial direct current stimulation group: 1) progressive eccentric exercises of the wrist extensors / 3 sets of 10 repetitions. 2) Extensor carpi radialis brevis muscle stretch/ 6 repetitions / 3 times before and 3 times after eccentric exercises with 30 seconds of rest between each repetition / 30 to 45 seconds each time. 3) sham transcranial direct current stimulation with an intensity of 2 mA for 30 seconds Pain. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: Visual analog scale. Functional disability. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: Patient-rated tennis elbow evaluation. Grip strength. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: manual dynamometer. Finger & hand dexterity. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: Perdue pegboard. Quality of life. Timepoint: pre-intervention, post-intervention, 4 weeks post-intervention. Method of measurement: 12-Item Short Form Survey. Shiraz University of Medical Sciences Approved 2022-10-19 Ethics committee of Shiraz University of Medical Science Shiraz University of Medical Sciences, Zand street, Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)