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IRCT20180804040685N6 IRCT 2026-01-19 Tehran University of Medical Sciences Effect of PRP injection on low back pain The Effect of Ultrasound-Guided PRP Injection Versus Corticosteroid Injection on Pain Relief and Functional Improvement in Patients with Low Back Pain due to Lumbar Facet Joint Involvement: A Double-Blind, Non-Inferiority Clinical Trial 2026-01-05 anticipated 30 Recruiting https://irct.ir/trial/88446 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use restricted randomization, specifically block randomization, in this study. Blocking is commonly used to achieve balance in the number of participants allocated to each study group. This feature helps researchers ensure equal group sizes, particularly when interim analyses are required during the sampling process. All blocks will be of equal size, and in this two-arm trial we will have three blocks of size 10, each consisting of 5 participants in the intervention group and 5 participants in the control group. Random selection of the generated blocks will be performed using random number–generation software such as R, and three random numbers from 1 to 3 will be generated to select the blocks. For allocation concealment, we will use allocation concealment, which refers to the method used to implement the random sequence among study participants in such a way that the assigned group is not known prior to allocation. This will be achieved using sequentially numbered, sealed, opaque envelopes (SNOSE). In this method, each generated random sequence is recorded on a card, and the cards are placed sequentially inside envelopes. To preserve the random sequence, the envelopes are numbered in the same order on their outer surface. The envelopes are then sealed and placed sequentially in a box. At the start of participant enrollment, based on the order of entry of eligible participants into the study, the envelopes are opened sequentially, and the allocated group for each participant is then revealed, Blinding description: This study is a double-blind randomized clinical trial with two parallel groups, in which both the patients and the data analyst are blinded to group allocation. To ensure patient blinding, blood samples will be taken from all patients (with a smaller volume drawn from the corticosteroid group), and all patients will receive the injection in the prone position. Patients will remain unaware of the substance being injected. To maintain blinding of the analyst—who is an individual other than the physician/investigator and the data collection personnel—the data will be provided for analysis coded only as Group A and Group B, without revealing the actual group assignments. 3 Low Back Pain due to Lumbar Facet Joint Involvement. Intervention 1: Intervention group: Initially, approximately 15 mL of peripheral venous blood will be collected from each patient using a blood collection set and sterile syringes containing an anticoagulant. The sample will be immediately centrifuged for 5 minutes at 3200 rpm. An Alpha kit will be used in this process, yielding platelet-rich plasma (PRP) with a concentration of approximately five times the baseline platelet level. Each patient will receive an injection of 2.5 mL of autologous PRP, prepared from their own peripheral blood, combined with 0.5 mL of lidocaine (to reduce procedural pain and improve patient comfort), for a total volume of 3 mL. The injection technique, volume, site, and procedural conditions will be identical to those of the control group to ensure comparable patient experience and to control for the placebo effect. The injection will be administered periarticularly into the lumbar facet joint using a spinal needle under ultrasound guidance, performed by an experienced specialist in Physical Medicine and Rehabilitation. Only one injection session will be performed. Intervention 2: Control group: Initially, approximately 5 mL of peripheral venous blood will be collected from each patient using a blood collection set and sterile syringes containing an anticoagulant and sent to the laboratory for complete blood count (CBC) testing for ethical reasons and to maintain blinding. In this group, a periarticular corticosteroid injection consisting of triamcinolone 40 mg (1 mL) combined with 2 mL of 2% lidocaine (to reduce procedural pain and improve patient comfort), for a total volume of 3 mL, will be administered. The injection technique, volume, site, and procedural conditions will be identical to those of the intervention group to ensure a comparable subjective experience and to control for the placebo effect. The injection will be performed periarticularly into the lumbar facet joint using a spinal needle under ultrasound guidance, by an experienced specialist in Physical Medicine and Rehabilitation. Only one injection session will be performed. 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 more data at present.
public Zahra Biglari Nejad Ghiri
Jalal-Al-Ahmad St, North Kregar St, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 3222 dr.lili7264@gmail.com Tehran University of Medical Sciences scientific Hamid Reza Fateh
Jalal-Al-Ahmad St, North Karegar St, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 3222 hr-fateh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Chronic low back pain lasting more than 3 months Pain score greater than 4 on the visual analog scale (VAS > 4) Inadequate response to noninvasive and conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) and physical therapy based on the patient's medical history Normal lower limb muscle strength on neurological examination Unilateral lumbar facet joint pain Local tenderness on physical examination over the facet joint and pain elicited during lumbar hyperextension maneuvers Single-level involvement of the facet joint 18 years 65 years Both Age younger than 18 years or older than 65 years Acute low back pain with a duration of less than 3 months Pain score of 4 or ≤4 on the Visual Analog Scale Abnormal lower extremity muscle strength on neurological examination Involvement of more than one facet joint (multi-level involvement) M54.5 Low back pain Treatment - Drugs Treatment - Drugs Intervention group: Initially, approximately 15 mL of peripheral venous blood will be collected from each patient using a blood collection set and sterile syringes containing an anticoagulant. The sample will be immediately centrifuged for 5 minutes at 3200 rpm. An Alpha kit will be used in this process, yielding platelet-rich plasma (PRP) with a concentration of approximately five times the baseline platelet level. Each patient will receive an injection of 2.5 mL of autologous PRP, prepared from their own peripheral blood, combined with 0.5 mL of lidocaine (to reduce procedural pain and improve patient comfort), for a total volume of 3 mL. The injection technique, volume, site, and procedural conditions will be identical to those of the control group to ensure comparable patient experience and to control for the placebo effect. The injection will be administered periarticularly into the lumbar facet joint using a spinal needle under ultrasound guidance, performed by an experienced specialist in Physical Medicine and Rehabilitation. Only one injection session will be performed. Control group: Initially, approximately 5 mL of peripheral venous blood will be collected from each patient using a blood collection set and sterile syringes containing an anticoagulant and sent to the laboratory for complete blood count (CBC) testing for ethical reasons and to maintain blinding. In this group, a periarticular corticosteroid injection consisting of triamcinolone 40 mg (1 mL) combined with 2 mL of 2% lidocaine (to reduce procedural pain and improve patient comfort), for a total volume of 3 mL, will be administered. The injection technique, volume, site, and procedural conditions will be identical to those of the intervention group to ensure a comparable subjective experience and to control for the placebo effect. The injection will be performed periarticularly into the lumbar facet joint using a spinal needle under ultrasound guidance, by an experienced specialist in Physical Medicine and Rehabilitation. Only one injection session will be performed. Pain intensity. Timepoint: Measurement of pain intensity at baseline (before the intervention) and at 30 and 90 days after initiation of the intervention. Method of measurement: Visual Analog Scale. Functional disability. Timepoint: Measurement of functional disability at baseline (before the intervention) and at 30 and 90 days after initiation of the intervention. Method of measurement: Oswestry Disability Index. Physical disability. Timepoint: Measurement of physical disability at baseline (before the intervention) and at 30 and 90 days after initiation of the intervention. Method of measurement: Roland-Morris Disability Questionnaire. Analgesic medication use. Timepoint: During the 3-month follow-up period. Method of measurement: Daily medication diary. Adverse events and safety. Timepoint: During the 3-month follow-up period. Method of measurement: Adverse Event Checklist. Need for additional treatments or surgical intervention. Timepoint: During the 3-month follow-up period. Method of measurement: Regular monitoring and follow-up visits by the physician/investigator. Tehran University of Medical Sciences Approved 2025-12-08 Research Ethics Committees of Shariati Hospital, Tehran University of Medical Sciences Jalal aleahmad Highway Tehran Tehran Iran (Islamic Republic of)