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IRCT20191002044951N2 IRCT 2025-05-29 Iran University of Medical Sciences Evaluation and Comparison of the Effectiveness of Corticosteroid Injection and Electroacupuncture in Controlling Pain and Improving Performance in Patients with Lateral Epicondylitis (Tennis Elbow) Evaluation and Comparison of the Effectiveness of Corticosteroid Injection and Electroacupuncture in Controlling Pain and Improving Performance in Patients with Lateral Epicondylitis (Tennis Elbow) 2025-05-23 anticipated 44 Complete https://irct.ir/trial/83529 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. Randomization: In this study, participants will be allocated into two treatment groups using a restricted randomization method. To ensure balance in the number of individuals in each group, blocks of equal size will be used. Given a sample size of 44 participants, 11 blocks of 4 individuals each will be designed. Each block will include two participants assigned to the corticosteroid group and two to the electroacupuncture group. The allocation order within each block will be determined randomly using a random number generator software. These combinations will be written on identical pieces of paper, each placed inside an opaque envelope. The envelopes will be organized sequentially within each block. When a patient visits the clinic, they will be asked to randomly select one envelope. The number inside the envelope will determine the patient’s treatment group and will be recorded on designated forms. Preparation of the Randomization List: A randomization list containing various group combinations for each block (e.g., 1-2-2-1) will be generated using the random number generation feature of SPSS software. This list will be provided to the principal investigator and will be used to assign patients to the groups. Preparation of the Envelopes: Papers of equal size will be prepared, each labeled with the numbers “1” (corticosteroid) or “2” (electroacupuncture). Each block will contain a combination of numbers according to the randomization list. The papers will be individually placed in opaque, identical envelopes. These envelopes will be numbered sequentially and organized according to their corresponding blocks. Assignment of Patients to Groups: When a participant visits the clinic, they will randomly select an envelope from the relevant block. The number inside the envelope will indicate the treatment group (1 or 2) to which the patient is assigned. The researcher will record the allocation code, and the remaining envelopes in the block will be stored until the block is fully used, Blinding description: Blinding of Assessors and Data Analysts: Assessors: Outcome assessors (e.g., for VAS and PRTEE questionnaires) will be blinded to the treatment group allocation. To ensure this, participant files will be coded anonymously as either “A” or “B”. Data Analyst: The final data will be reviewed and analyzed by a data analyst who will also be blinded to the treatment groups and will only work with the anonymous codes (“A” and “B”). Bias Control: All interactions with participants will be handled by the treatment team, and assessments will be conducted in a separate room by independent, neutral personnel. Data will be encoded separately, and only the principal investigator will have access to the encryption key. N/A Lateral epicodylitis. Intervention 1: Intervention group: Corticosteroid Injection Group (Group 1):Participants in this group will receive a single corticosteroid injection. The corticosteroid used will be triamcinolone acetonide, a long-acting agent commonly used in the treatment of inflammatory conditions. A dose of 1 mL (40 mg/mL) will be prepared.The injection will be administered at the point of maximal tenderness over the lateral epicondyle, as determined by palpation. The patient will be positioned comfortably with the elbow slightly flexed and supported during the procedure. Intervention 2: Intervention group: Electroacupuncture Group (Group 2):Participants in this group will undergo six sessions of electroacupuncture over a three-week period, with treatments administered twice per week.Sterile, single-use acupuncture needles (0.25 mm in diameter and 40 mm in length) will be used to ensure patient safety and reduce the risk of infection.Needles will be inserted bilaterally at predetermined acupuncture points around the lateral epicondyle. Common points include Quchi (LI11), Shousanli (LI10), and Ashi points (tender points identified by palpation). Electroacupuncture Details:An electroacupuncture device will be connected to pairs of needles to deliver a low-frequency electrical current (2–4 Hz).The intensity of the electrical stimulation will be adjusted according to the patient’s tolerance, producing sensations ranging from mild tingling to slight muscle contractions.Each session will last for 30 minutes, during which the patient will remain in a resting position.Treatment will be administered twice per week for a total of three weeks, resulting in six sessions overall. Yes - There is a plan to make this available What will be shared: All data will be delivered to the research center in the form of an Excel file. When: The access period begins six months after the publication of the results. To whom: It will be available to researchers affiliated with academic and scientific institutions. Conditions: No decision has been made yet Where to obtain: Data Availability and Contact Information: For further information, access to the data, or details regarding the analyses, please contact the study coordinator: Name: Dr. Kourosh Mansoori Phone Number: +98 912 146 7966 Institutional Address: Shafa Yahyaian Hospital Email: Mansoori.k@iums.ac.ir How to obtain: The requester of the documents can correspond with the author of the articles and send her request through the contact number or email registered in the previous section and receive the information in less than one working week and also state the purpose of receiving the data.(feminine) The requester of the documents can correspond with the author of the articles and send his request through the contact number or email registered in the previous section and receive the information in less than one working week and also state the purpose of receiving the data Comments:
public Kourosh Mansory
Baharestan square
Tehran Iran (Islamic Republic of) 14597943644 +98 912 375 2812 Mansoori.k@iums.ac.ir Iran University of Medical Sciences scientific Romina karimi
Beh Afarin St , Valiasr Square., Firozgar Hospital
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1000 Rominakarimi1374@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Adults aged between 18 and 65 years Clinically diagnosed with lateral epicondylitis (tennis elbow) for at least 6 weeks. Experiencing pain that has not responded to conservative treatments (e.g., rest, physiotherapy). the Visual Analog Scale ≥ 4 (VAS; 0–10) at baseline. Ability to provide informed consent. 18 years 65 years Both Occurrence of serious adverse events resulting from therapeutic interventions (such as infection, severe reaction to injection, or electroacupuncture). Non-compliance with post-treatment instructions:a) In the injection group: engaging in intense physical activities during the restricted period after injection.b) In the electroacupuncture group: failure to follow recommendations regarding rest or proper use of the treated limb. Lack of patient cooperation in continuing treatment sessions or scheduled evaluations. Emergence of new medical conditions that may affect the study outcomes (e.g., surgery or acute illnesses). Patient’s decision to withdraw from the study at any time, even after signing the informed consent. Investigator’s judgment that continued participation may pose a risk to the patient’s health. M77.1 Lateral epicondylitis Treatment - Other Treatment - Other Intervention group: Corticosteroid Injection Group (Group 1):Participants in this group will receive a single corticosteroid injection. The corticosteroid used will be triamcinolone acetonide, a long-acting agent commonly used in the treatment of inflammatory conditions. A dose of 1 mL (40 mg/mL) will be prepared.The injection will be administered at the point of maximal tenderness over the lateral epicondyle, as determined by palpation. The patient will be positioned comfortably with the elbow slightly flexed and supported during the procedure. Intervention group: Electroacupuncture Group (Group 2):Participants in this group will undergo six sessions of electroacupuncture over a three-week period, with treatments administered twice per week.Sterile, single-use acupuncture needles (0.25 mm in diameter and 40 mm in length) will be used to ensure patient safety and reduce the risk of infection.Needles will be inserted bilaterally at predetermined acupuncture points around the lateral epicondyle. Common points include Quchi (LI11), Shousanli (LI10), and Ashi points (tender points identified by palpation). Electroacupuncture Details:An electroacupuncture device will be connected to pairs of needles to deliver a low-frequency electrical current (2–4 Hz).The intensity of the electrical stimulation will be adjusted according to the patient’s tolerance, producing sensations ranging from mild tingling to slight muscle contractions.Each session will last for 30 minutes, during which the patient will remain in a resting position.Treatment will be administered twice per week for a total of three weeks, resulting in six sessions overall. Pain according to VAS score and PRTEE. Timepoint: The outcomes are assessed at three time points: at baseline, 3 months, and 6 months after the intervention. Method of measurement: VAS score and PRTEE. Iran University of Medical Sciences Approved 2025-04-01 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences Hemmat Highway, near Milad Tower, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)