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IRCT20251027067789N1 IRCT 2025-12-13 Tehran University of Medical Sciences Evaluation of the difference in the effect of platelet-rich plasma (PRP) injection using the Peppering ands single injection techniques on pain and function in patients with elbow extensor tendinopathy: A randomized, double-blind clinical trial Evaluation of the difference in the effect of platelet-rich plasma (PRP) injection using the Peppering ands single injection techniques on pain and function in patients with elbow extensor tendinopathy: A randomized, double-blind clinical trial 2025-12-22 anticipated 34 Recruiting https://irct.ir/trial/87548 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The distribution of volunteers will be done by random block design with variable blocks of two, four or six (one group with the symbol A and the other group with the symbol B) and using the random number table of the Random allocation software. The sample allocation ratio will be 1:1 and volunteers will be randomly assigned to one of the two injection groups, Single and Peppering, Blinding description: This study was conducted as a randomized, double-blind clinical trial. Both participants and outcome assessors were blinded to the type of intervention. To maintain blinding, all injections were performed behind a sterile drape and out of the patient’s visual field, using identical syringes, equipment, and a uniform local anesthesia protocol in both groups. The duration of the procedure was also standardized to avoid any perceptible differences between the two injection techniques. All injections were performed by a single physician who, due to the inherent differences between the Peppering and Single techniques, was aware of the allocation but had no role in patient assessment or data collection. Outcome measures, including the Numerical Rating Scale (NRS), the Patient-Rated Tennis Elbow Evaluation (PRTEE), grip strength, and Pain Pressure Threshold (PTT), were recorded by an independent assessor blinded to group assignment. Participants were randomized into two groups in a 1:1 ratio using sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The success of blinding was evaluated during follow-up by directly asking both participants and assessors to guess the assigned group. Unblinding was allowed only in cases of medical necessity and was fully documented. 3 Lateral elbow extensor tendinopathy. Intervention 1: First intervention group: Injection of platelet-rich plasma (PRP) produced by a kit manufactured by Celltech Biogen using the peppering method along with conventional treatments including Counterforce brace and wrist extensor stretching exercises. Intervention 2: Second Intervention group: Injection of platelet-rich plasma (PRP) produced by a kit manufactured by Celltech Biogen Company using a single injection method along with conventional treatments including Counterforce brace and wrist extensor stretching exercises. 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 Bahareh Golestani
Sina Hospital, Hasanabad Square, Imam Khomeini street
Tehran Iran (Islamic Republic of) 5395514176 +98 21 6491 0700 golestani_b@razi.tums.ac.ir Tehran University of Medical Sciences scientific Maryam Abolhasani
Sina Hospital, Hasanabad Square, Imam Khomeini street
Tehran Iran (Islamic Republic of) 5395514176 +98 21 6491 0700 maryam.abolhasani@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Pain or tenderness to touch over the lateral epicondylitis and the insertion site of the extensor tendons Pain with gripping a hand dynamometer The pain may be aggravated by stretching or contracting the wrist extensors. At least a score of 2 on the NRS scale from 0 to 10. 18 years 65 years Both Have a history of surgery on the upper limb. Have had surgery related to the cervical spine. Have a history of elbow dislocation or elbow fracture or tendon rupture Have a history of whiplash injury within the past 6 weeks. Have a history of fibromyalgia Have a history of cervical canal stenosis History of chronic inflammatory disease such as: lupus - rheumatoid arthritis - psoriasis Failure to participate in physical therapy, acupuncture, or chiropractic in the past 3 months Having symptoms of nerve compression, such as weakness of upper limb muscles, decreased deep reflexes in the upper limb, and decreased sensation Central nervous system involvement, such as MS Neurological _ Psychiatric or cognitive disorders and pregnancy The presence of any contraindications for physical therapy, such as skin wounds, infections, and malignancies Absence of a bleeding disorder No use of NSAIDs, steroids, or aspirin within the previous week M77.1 Lateral epicondylitis Treatment - Other Treatment - Other First intervention group: Injection of platelet-rich plasma (PRP) produced by a kit manufactured by Celltech Biogen using the peppering method along with conventional treatments including Counterforce brace and wrist extensor stretching exercises Second Intervention group: Injection of platelet-rich plasma (PRP) produced by a kit manufactured by Celltech Biogen Company using a single injection method along with conventional treatments including Counterforce brace and wrist extensor stretching exercises. Pain intensity. Timepoint: It is being evaluated 4 and 8 weeks after injection. Method of measurement: Pain intensity will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain.". Grip strength. Timepoint: It is being evaluated 4 and 8 weeks after injection. Method of measurement: Grip strength will be measured using a hand-held dynamometer, which quantifies the maximum force exerted by the participant's grip. The Pressure Pain Threshold. Timepoint: It is being evaluated 4 and 8 weeks after injection. Method of measurement: The Pressure Pain Threshold (PPT) will be measured using an algometer, a device that applies gradual pressure to a specific point on the body. The participant will report when the pressure becomes painful. The Patient-Rated Tennis Elbow (PRTE) questionnaire. Timepoint: It is being evaluated 4 and 8 weeks after injection. Method of measurement: The Patient-Rated Tennis Elbow (PRTE) questionnaire evaluates the severity of symptoms and functional limitations caused by tennis elbow. It uses a Likert scale (0-10) for scoring, where 0 means "no pain" or "no difficulty," and 10 represents "worst possible pain" or "unable to perform the activity. Its subscales include 1. Pain Subscale : Measures pain intensity during rest and specific activities. 2. Function Subscale: Assesses limitations in daily activities and work tasks. 3. Impact on Quality of Life. Tehran University of Medical Sciences Approved 2025-05-25 Sina Hospital - Tehran University of Medical Sciences (Research Ethics Committee) Sina Hospital, Hasanabad Square, Imam Khomeini street Tehran Tehran Iran (Islamic Republic of)