Evaluation and Comparison of the Effectiveness of Corticosteroid Injection and Electroacupuncture in Controlling Pain and Improving Performance in Patients with Lateral Epicondylitis (Tennis Elbow)

Main Goal: Compare the effectiveness of corticosteroid injection vs. electroacupuncture in managing pain and function in tennis elbow patients. Secondary Goals: Measure pain and function changes before and after treatment (3 and 6 months) using VAS and PRTEE. Compare outcomes between the two treatment groups. Practical Goal: Identify the more effective method to improve patient care and update clinical guidelines.

Participants will be randomly assigned to one of two groups: the corticosteroid group or the electroacupuncture group. The required sample size is 22 participants per group, totaling 44 participants in the study.

This study will be a single-blind, parallel-group RCT with two treatment arms The trial will be conducted at Firouzgar Hospital, Shafa Yahyaian Hospital, and Rasoul Akram Hospital.

Inclusion Criteria: 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 such as rest or physiotherapy. A baseline pain score of ≥ 4 on the Visual Analogue Scale (VAS). Ability to provide informed consent. Exclusion Criteria: History of corticosteroid injection or electroacupuncture for lateral epicondylitis within the past 6 months. Presence of systemic inflammatory conditions (e.g., rheumatoid arthritis). History of elbow surgery. Pregnant or breastfeeding women. Patients receiving anticoagulant therapy or with known bleeding disorders.

Participants will be randomly assigned to one of two treatment groups: 1. Corticosteroid Injection Group 2. Electroacupuncture Group

Pain reduction and improvement of quality of life in patients with tennis elbow.

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 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.

All data will be delivered to the research center in the form of an Excel file.

The access period begins six months after the publication of the results.

It will be available to researchers affiliated with academic and scientific institutions.

No decision has been made yet

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

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