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IRCT20250629066291N4 IRCT 2026-06-04 Shiraz University of Medical Sciences Added value of multifidus dry needling in improving pain and function in females with patellofemoral pain Added value of multifidus dry needling in improving pain and function in females with patellofemoral pain: A randomized clinical trial study 2026-06-20 anticipated 60 Pending https://irct.ir/trial/86881 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment method in this study will be the blocked permutation method (number of blocks 8 and block size 4) which will be generated using randomizer site. The samples will be assigned in a 1:1 ratio. Opaque, sealed envelopes will be used to conceal the assignment, Blinding description: The individual who performs the assessments is separate from the one who administers the treatments, and neither is aware of the other's work. The person responsible for randomization is also independent from both of the aforementioned individuals. 3 Unilateral Patellofemoral pain. Intervention 1: Intervention group:In the intervention group, dry needling of the lumbar multifidus and quadriceps femoris muscles will be performed three days per week (on alternate days) for one week. Dry needling will be administered by an experienced and trained physiotherapist. Throughout the treatment, a “clean technique” will be employed, which includes handwashing, the use of non‑latex examination gloves, and skin preparation with an alcohol swab prior to needle insertion.With the participant lying in a relaxed prone position, the multifidus muscle will be palpated in the region immediately lateral and adjacent to the interspinous spaces of the L4/L5 and L5/S1 vertebral levels, as determined by the examiner. To locate the L4/L5 and L5/S1 levels, the L4 vertebral level will first be identified by palpating the bilateral iliac crests, then tracing the intercristal line posterior‑medially to its intersection with the lumbar spine. This intersection point is considered the L3/L4 interspinous space. The examiner will then palpate caudally to identify the L4/L5 and L5/S1 interspinous spaces, thereby determining the L4/L5 and L5/S1 vertebral levels. (It should be noted that these anatomical landmarks can vary between individuals, which may present a significant challenge for precise vertebral level identification via palpation.)To detect the presence of myofascial trigger points—defined as palpable, painful nodules within muscle tissue (whether active or latent)—the identified sites will be treated with dry needling. While each participant remains in the prone position, a solid, sterile, single‑use needle will be inserted bilaterally into the lumbar multifidus muscles at the L3, L4, and L5 vertebral levels. Needle size (either 0.25 × 50 mm or 0.25 × 40 mm; Dongbang Medical, Korea) will be selected based on the participant’s body habitus. Intervention 2: Control group: In the control group, dry needling of the quadriceps femoris muscle alone will be administered as same as intervention group three days per week (on alternate days) for a total of one week. Yes - There is a plan to make this available What will be shared: Information collection form including primary outcomes, informed consent form and SPSS file When: After publication the results of the study To whom: Researchers working in academic and scientific institutions Conditions: Only for recording information in scientific databases Where to obtain: Correspondence with the project manager by email. Haghighat_fa@yahoo.com How to obtain: Maximum one month after sending the request by email Comments:
public Farzaneh Haghighat
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
shiraz Iran (Islamic Republic of) 7194815644 +98 71 3624 0101 haghighat_fa@yahoo.com Shiraz University of Medical Sciences scientific Farzaneh Haghighat
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
shiraz Iran (Islamic Republic of) 7194815644 +98 71 3624 0101 haghighat_fa@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age range: 18 to 40 years Complaint of anterior knee pain (pain around or behind the patella) that was not related to trauma and had persisted for at least 3 months. The intensity of knee pain in the past week, according to the Numeric Pain Rating Scale (NPRS), reported by the patient: between 3 and 6 Report of pain during at least two load-bearing activities on the patellofemoral joint, including: ascending or descending stairs, squatting, prolonged sitting with the knee flexed, jumping activities, and running Positive Clarke's sign test Score on the Kujala Anterior Knee Pain Scale (AKPS): less than 80 Completion of the informed consent form 18 years 40 years Female Osteoarthritis Ligament or meniscus injury Patellar instability, plica syndrome, Osgood-Schlatter disease, and Sinding-Larsen-Johansson syndrome Obvious structural deformities and known pathological conditions in the lower back, hip, and ankle Diagnosis of metabolic or neurological diseases such as diabetes or radicular pain Contraindications for dry needling, such as cardiovascular disease, coagulation disorders, use of anticoagulant medications, pregnancy, cancer, or needle phobia Receiving physiotherapy for knee pain within the past year History of knee surgery Receiving acupuncture, injection, or dry needling therapy for the knee or quadriceps muscles within the past 6 months Medical history of bleeding disorders Presence of central or peripheral neurological pathology M22.2X9 Patellofemoral disorders, unspecified knee Treatment - Other Treatment - Other Intervention group:In the intervention group, dry needling of the lumbar multifidus and quadriceps femoris muscles will be performed three days per week (on alternate days) for one week. Dry needling will be administered by an experienced and trained physiotherapist. Throughout the treatment, a “clean technique” will be employed, which includes handwashing, the use of non‑latex examination gloves, and skin preparation with an alcohol swab prior to needle insertion.With the participant lying in a relaxed prone position, the multifidus muscle will be palpated in the region immediately lateral and adjacent to the interspinous spaces of the L4/L5 and L5/S1 vertebral levels, as determined by the examiner. To locate the L4/L5 and L5/S1 levels, the L4 vertebral level will first be identified by palpating the bilateral iliac crests, then tracing the intercristal line posterior‑medially to its intersection with the lumbar spine. This intersection point is considered the L3/L4 interspinous space. The examiner will then palpate caudally to identify the L4/L5 and L5/S1 interspinous spaces, thereby determining the L4/L5 and L5/S1 vertebral levels. (It should be noted that these anatomical landmarks can vary between individuals, which may present a significant challenge for precise vertebral level identification via palpation.)To detect the presence of myofascial trigger points—defined as palpable, painful nodules within muscle tissue (whether active or latent)—the identified sites will be treated with dry needling. While each participant remains in the prone position, a solid, sterile, single‑use needle will be inserted bilaterally into the lumbar multifidus muscles at the L3, L4, and L5 vertebral levels. Needle size (either 0.25 × 50 mm or 0.25 × 40 mm; Dongbang Medical, Korea) will be selected based on the participant’s body habitus. Control group: In the control group, dry needling of the quadriceps femoris muscle alone will be administered as same as intervention group three days per week (on alternate days) for a total of one week. Pain intensity. Timepoint: Before intervention; One day after intervention period. Method of measurement: Numeric Pain Rating Scale (NPRS). Physical Function. Timepoint: Before intervention; One day after intervention period. Method of measurement: Kujala Questionnaire (Anterior Knee Pain Scale, AKPS)-step down - mSEBT. Pressure Pain Threshold. Timepoint: Before intervention; One day after intervention period. Method of measurement: Algometer. Shiraz University of Medical Sciences Approved 2026-03-11 Ethics committee of Shiraz University of Medical Sciences Ethics committee, Research and Technology Vice-Chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand Street shiraz Fars Iran (Islamic Republic of)