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IRCT20170516034003N10 IRCT 2025-02-26 Rasht University of Medical Sciences The effects of dry needling, shock wave therapy and corticosteroid injection in patients with tennis elbow Evaluation of short-term and long-term effects of dry needling, shock wave therapy and corticosteroid injection on pain and sonographic findings of patients with tennis elbow: Randomized controlled clinical trial 2024-01-20 anticipated 68 Complete https://irct.ir/trial/74447 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, all participants will have an equal chance of being assigned to each of the study groups. In this study, 64 patients with tennis elbow will be divided into four groups through block randomization with a block size of 8 in 8 blocks. Sequence generation was obtained through the sealed envelope site (www.sealedenvelope.com/simple-randomiser/v1/lists) as follows. Allocation concealment will be done through sealed envelopes. In this way, the obtained sequence is placed in envelopes in order. Then, for each patient who visits, the envelope that is in the selection queue is removed and if the letter A is observed, the first group intervention will be performed for the patient. If the letter B is observed, the second group intervention will be performed and similarly with the letters C and D, the third and fourth group interventions will be performed, Blinding description: The examiner and statistical analyzer won't know anything about the kind of treatment. N/A Lateral epicondylitis. Intervention 1: Control group: Drug therapy and the use of splints or elbow braces are considered as the usual treatment for tennis elbow. Drug treatment for all patients will be done in the form of naproxen 500 tablets, one daily for up to three weeks. The splint will allow movement of the wrist, fingers and elbow and will place the wrist in 5 degrees of extension. This splint will be used for 6 to 8 hours a day and for 4 weeks. It should be noted that due to ethical considerations, treatment will be performed in all studied groups. Intervention 2: Intervention group: Injection treatment: In this method, one milliliter of corticosteroid (Betamethasone) is injected into the common extensor tendon along with lidocaine. Intervention 3: Intervention group: dry needling: In this method, after cleaning the skin, three needles (0.25 x 50 mm) and (Tony, Stockholm, Sweden) will be inserted back and forth in the trigger points and painful tendon area. These needles are rotated 5 times and will remain in place for 10 minutes. This whole process will be repeated twice with a ten minute rest interval. After the needle is removed, the desired area is pressed with cotton to prevent bleeding. This procedure will continue for three times a week and up to ten sessions. Dry needling was performed by a skilled physiotherapist with more than ten years of experience. Intervention 4: Intervention group: shockwave therapy:shockwave therapy will be performed using a shockwave device (BTL, SWT TOPLINE UK). The parameters used will be: 10 Hz, 2000 pulses, 2-4 bar pressure. The patient will be placed in a supine position, the elbow slightly bent and the forearm pronated. The R15 shock wave therapy applicator will be placed on the most sensitive point and around it. No topical ointment will be used before the treatment. The treatment will be done two days a week for ten sessions. Yes - There is a plan to make this available What will be shared: Sharing is done after the end of the study. The total potential data can be shared after unidentifications of individuals. When: Start the access period 6 months after publicating the results To whom: Researchers working in universities Conditions: - Research that is in line with current study. - Data correlation analysis is allowed. -It is preferred to have a university degree and be a researcher in the desired field. Where to obtain: Adress: Physiotherapy section, Block 2, , Poursina hospital, Namjoo St, Rasht. Kamran Ezzati Ez_kamran@yahoo.com How to obtain: A written request for data from the relevant university with the name and academic degree of the researcher Comments:
public Elahe Rafie
Deputy of Research, Opposie to Azodi Stadium, Namjoo St, Rasht, Iran
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 2639 Research@gums.ac.ir Rasht University of Medical Sciences scientific Kamran Ezzati
Central Office of Guilan University of Medical Sciences, Parastar St., Rasht, I.R. Iran
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3369 0099 kamranezzati@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Visual analogue scale (VAS) score of 3 or more Pain in the lateral epicondyle region of the elbow, which increases when palpating the external tendons. 30 years 55 years Both People with neuropathy such as thyroid problems. People with neck and shoulder myopathy. People with a history of neck and shoulder, elbow and wrist surgery. People with cancer, infection, pain and lung disease, acquired immunodeficiency virus. People with psychosocial disorders who were evaluated using the Persian version of the DASS-21 stress-anxiety-depression questionnaire and obtained scores above the normal range. (Normal scores: maximum 9= depression, maximum 7 = anxiety, maximum 14 = stress) Patients with osteochondritis of lateral epicondyle, osteoarthritis of the lateral compartment of the elbow, varus instability and the presence of radial tunnel syndrome. M77.1 Lateral epicondylitis Treatment - Drugs Treatment - Drugs Rehabilitation Rehabilitation Control group: Drug therapy and the use of splints or elbow braces are considered as the usual treatment for tennis elbow. Drug treatment for all patients will be done in the form of naproxen 500 tablets, one daily for up to three weeks. The splint will allow movement of the wrist, fingers and elbow and will place the wrist in 5 degrees of extension. This splint will be used for 6 to 8 hours a day and for 4 weeks. It should be noted that due to ethical considerations, treatment will be performed in all studied groups. Intervention group: Injection treatment: In this method, one milliliter of corticosteroid (Betamethasone) is injected into the common extensor tendon along with lidocaine. Intervention group: dry needling: In this method, after cleaning the skin, three needles (0.25 x 50 mm) and (Tony, Stockholm, Sweden) will be inserted back and forth in the trigger points and painful tendon area. These needles are rotated 5 times and will remain in place for 10 minutes. This whole process will be repeated twice with a ten minute rest interval. After the needle is removed, the desired area is pressed with cotton to prevent bleeding. This procedure will continue for three times a week and up to ten sessions. Dry needling was performed by a skilled physiotherapist with more than ten years of experience Intervention group: shockwave therapy:shockwave therapy will be performed using a shockwave device (BTL, SWT TOPLINE UK). The parameters used will be: 10 Hz, 2000 pulses, 2-4 bar pressure. The patient will be placed in a supine position, the elbow slightly bent and the forearm pronated. The R15 shock wave therapy applicator will be placed on the most sensitive point and around it. No topical ointment will be used before the treatment. The treatment will be done two days a week for ten sessions Pain. Timepoint: Before intervention, After treatments, 3 month follow-up. Method of measurement: Visual Analogue Scale. Echogenicity intensity. Timepoint: Before intervention, After treatments, 3 month follow-up. Method of measurement: Using ultrasonography. Common extensor tendon thickness. Timepoint: Before intervention, After treatments, 3 month follow-up. Method of measurement: Using ultrasonography. Rasht University of Medical Sciences Approved 2023-06-14 Ethics committee of Guilan University of Medical Sciences 5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran Rasht Guilan Iran (Islamic Republic of)