Идёт набор NCT07548034

Ultrasound-guided Needle Percutaneous Electrolysis With Therapeutic Exercise in Femoroacetabular Impingement Syndrome

Без фазы С лечением Femoro Acetabular Impingement Hip Pain Iliopsoas Syndrome Groin Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ultrasound-guided percutaneous needle electrolysis, Therapeutic exercise program.
Кому может быть актуально: Состояния в реестре: Femoro Acetabular Impingement, Hip Pain, Iliopsoas Syndrome, Groin Pain. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Ultrasound-guided Percutaneous Needle Electrolysis Combined With Therapeutic Exercise in Femoroacetabular Impingement Syndrome: a Randomized Pilot Clinical Trial.

Обзор

Hip pain in the front of the hip is common and can make daily activities and sports difficult. One frequent cause is femoroacetabular impingement, also known as hip impingement. This clinical trial is studying whether adding ultrasound-guided percutaneous electrolysis - a minimally invasive physiotherapy technique that uses a fine needle and a small electrical current - to a program of specific exercises works better than doing the exercises alone. Participants will be randomly assigned to one of two groups: * One group will receive two sessions of percutaneous electrolysis plus a home exercise program. * The other group will follow the same home exercise program without percutaneous electrolysis. The study will last five weeks. Researchers will measure pain, hip movement, and hip function at the beginning, after one week, and after four weeks. They will also record any side effects. The main goal is to find out if adding percutaneous electrolysis helps reduce hip pain and improve function more than exercise alone. This pilot study will help determine if this technique could be a safe and effective non-surgical treatment option for people with pain in the front of the hip.

Подробное описание

Femoroacetabular impingement is a common cause of anterior hip pain in young and middle-aged adults. This condition involves abnormal mechanical contact between the proximal femur and the acetabular rim, which can lead to labral damage, cartilage injury, and pain. Soft tissue structures, particularly the iliopsoas tendon and its relationship with the anterior capsulolabral complex, frequently contribute to the symptoms.

Ultrasound-guided percutaneous electrolysis is a minimally invasive technique used in physiotherapy. It involves the application of a controlled galvanic current through a fine needle inserted under ultrasound guidance into targeted soft tissues, with the aim of reducing pain and promoting tissue repair.

This randomized pilot clinical trial will compare the effectiveness and safety of ultrasound-guided percutaneous electrolysis combined with a therapeutic exercise program versus the same therapeutic exercise program alone in participants with anterior hip pain compatible with femoroacetabular impingement.

Eligible participants will be randomly allocated to one of two parallel groups.

Both groups will follow a standardized home-based exercise program focused on hip mobility, gluteal strengthening, core stability, and controlled hip flexor activation. The experimental group will additionally receive two sessions of ultrasound-guided percutaneous electrolysis, performed one week apart.

Primary and secondary outcomes will include pain intensity during provocative tests, hip range of motion to the first onset of pain, and self-reported hip function. All outcome assessments will be conducted by a blinded evaluator at baseline, one week, and four weeks after the first intervention session. Adverse events will be systematically recorded.

The results of this pilot study will provide preliminary evidence regarding the potential additive benefit of percutaneous electrolysis to exercise therapy and will inform the design and sample size calculation of future larger-scale randomized controlled trials

Вмешательства

Другое Ultrasound-guided percutaneous needle electrolysis
Ultrasound-guided percutaneous needle electrolysis will be applied to the iliopsoas region targeting hyperechoic fibrotic tissue near the anterior hip joint. The procedure will be performed using a sterile needle under real-time ultrasound guidance with a long-axis in-plane approach from lateral to medial. Electrical current will be delivered with parameters of 2.5 mA for 3 seconds, with a total of 3 applications per session. Two sessions will be performed, one at baseline and one after 7 days.
Поведенческое Therapeutic exercise program
Participants will perform a home-based therapeutic exercise program focused on lumbopelvic stability, hip strength, and controlled mobility. Exercises include glute bridge, bird dog, isometric hip flexion, and controlled hip flexion mobility. The program consists of 3 sets of 10 repetitions per exercise, performed 3 to 4 times per week over a 4-week period. Exercises will be performed within pain-free ranges and adjusted according to individual tolerance. Initial instruction will be provided by

Первичные конечные точки

Mean Numeric Rating Scale (NRS) pain score during provocative hip tests [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]

Вторичные конечные точки (8)

Numeric Rating Scale (NRS) pain during SLR test [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Numeric Rating Scale (NRS) pain during FADIR test [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Numeric Rating Scale (NRS) pain during HEC test [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Hip flexion range of motion to first onset of pain (P1) [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Hip external rotation range of motion to first onset of pain (P1) [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Hip internal rotation range of motion to first onset of pain (P1) [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Hip function and quality of life (Hip Outcome Tool-12, iHOT-12Sv) [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Adverse events [Срок оценки: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]

Критерии участия

Критерии включения

Anterior hip pain (inguinal region) lasting more than 3 months
Numeric Rating Scale (NRS) pain score ≥ 4/10 during at least one provocative test
Positive result in at least one of the following clinical tests: Straight Leg Raise (SLR), Flexion-Adduction-Internal Rotation (FADIR), or Hip-External Rotation-Flexion-Ceiling (HEC)
Ultrasound findings compatible with pseudofibrotic tissue near the iliopsoas tendon at the anterosuperior acetabular recess
Age between 18 and 55 years
Able to provide written informed consent