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IRCT20260404069021N1 IRCT 2026-05-07 Birjand University of Medical Sciences Comparison of acupuncture and high intensity laser in lateral epicondylitis Clinical trial of comparison between acupuncture and high intensity laser on improving pain and upper limb function in lateral epicondylitis 2025-10-17 anticipated 34 Complete https://irct.ir/trial/89379 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient allocation into two groups, intervention (high-power laser) and control (acupuncture), was performed using the Balanced Block Randomization method. For generating the random sequence, fixed block sizes of 4 with an allocation ratio of 1:1 were used (in each block, 2 individuals were assigned to the laser group and 2 to the acupuncture group). The random sequence was generated by an individual not involved in the treatment and patient assessment process, utilizing the R software and the ‘blockrand’ package. For Allocation Concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) were employed. Each envelope was labeled with the patient’s number, and the type of intervention was placed inside, with the respective envelope being opened only after the patient entered the study and provided informed consent. N/A Lateral epicondylitis. Intervention 1: Intervention Group 1: Medical acupuncture based on Western approach will be performed by a specialist in physical medicine. This group will consist of 5 treatment sessions, with patients receiving therapy three times a week. The treatment will be applied to the origin of extensor muscles of the elbow. Additional details regarding the intervention: Number of sessions: 5 sessions. Duration of each session: 45 minutes. Frequency per week: three times per week. Method of administration: Needles are inserted directly into specific points according to the treatment protocol. Equipment and consumables: Acupuncture needles from the brand SMC, with specifications of 0.25 mm diameter and 25 mm length, produced according to safety and hygiene standards. Intervention 2: Intervention Group 2: High-intensity laser therapy will be administered by a specialist in physical medicine. This group will consist of 5 treatment sessions, with patients receiving therapy three times a week. Additional details regarding the intervention: Therapeutic Modality: High-intensity laser therapy using the LASER-NET device. Wavelength: 940 nm. Power: 10 Watts. Energy Delivered: 1800 Joules Duration of each session: 5 minutes. Frequency per week: three times per week. Method of administration: The laser will be applied according to the treatment protocol. Equipment and consumables: LASER-NET high-intensity laser device. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Amirhossein Ahmadi
No. 85, Alley 40, Emamat Street, Azadshahr Boulevard, Mashhad, Razavi Khorasan Province, Iran
Mashhad Iran (Islamic Republic of) 9188779677 +98 51 3607 3317 amirhossein.a@bums.ac.ir Birjand University of Medical Sciences scientific Amirhossein Ahmadi
No. 85, Alley 40, Emamat Street, Azadshahr Boulevard, Mashhad, Razavi Khorasan Province, Iran
Mashhad Iran (Islamic Republic of) 988779677 +98 51 3607 3317 amirhossein.a@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Persistent pain and tenderness over the lateral epicondyle for at least three months, unresponsive to conservative management Exacerbation of pain over the lateral epicondyle during resisted wrist extension no limit no limit Both Diagnosis of rheumatoid arthritis Presence of a major psychiatric disorder lack of consent to participate Presence of active malignancy. Pregnancy. Presence of rheumatologic diseases or current use of rheumatologic medications. History of corticosteroid injection within the past 6 months. Prior elbow surgery. Diagnosis of systemic lupus erythematosus (SLE). opioid compounds users M77.1 Lateral epicondylitis Treatment - Devices Treatment - Devices Intervention Group 1: Medical acupuncture based on Western approach will be performed by a specialist in physical medicine. This group will consist of 5 treatment sessions, with patients receiving therapy three times a week. The treatment will be applied to the origin of extensor muscles of the elbow. Additional details regarding the intervention: Number of sessions: 5 sessions. Duration of each session: 45 minutes. Frequency per week: three times per week. Method of administration: Needles are inserted directly into specific points according to the treatment protocol. Equipment and consumables: Acupuncture needles from the brand SMC, with specifications of 0.25 mm diameter and 25 mm length, produced according to safety and hygiene standards. Intervention Group 2: High-intensity laser therapy will be administered by a specialist in physical medicine. This group will consist of 5 treatment sessions, with patients receiving therapy three times a week. Additional details regarding the intervention: Therapeutic Modality: High-intensity laser therapy using the LASER-NET device. Wavelength: 940 nm. Power: 10 Watts. Energy Delivered: 1800 Joules Duration of each session: 5 minutes. Frequency per week: three times per week. Method of administration: The laser will be applied according to the treatment protocol. Equipment and consumables: LASER-NET high-intensity laser device. The pain score based on the Visual analogue scale. Timepoint: Baseline (before intervention), post-intervention (after 2 weeks of treatment), and follow-up (1 month after the end of the intervention/week 6). Method of measurement: Visual analogue scale. Upper limb function score based on Quickdash questionnaire. Timepoint: Baseline (before intervention), post-intervention (after 2 weeks of treatment), and follow-up (1 month after the end of the intervention/week 6). Method of measurement: Quickdash questionnaire. Birjand University of Medical Sciences Approved 2025-10-08 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical Sciences, Ghaffari St., Birjand, South Khorasan, Iran Birjand South Khorasan Iran (Islamic Republic of)