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Recruiting NCT07548034

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

No phase Interventional Femoro Acetabular Impingement Hip Pain Iliopsoas Syndrome Groin Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided percutaneous needle electrolysis, Therapeutic exercise program.
Who it may be relevant to
Registry conditions: Femoro Acetabular Impingement, Hip Pain, Iliopsoas Syndrome, Groin Pain. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

  • Other 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.
  • Behavioral 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

Primary outcome measures

  • Mean Numeric Rating Scale (NRS) pain score during provocative hip tests [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
Secondary outcome measures (8)
  • Numeric Rating Scale (NRS) pain during SLR test [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Numeric Rating Scale (NRS) pain during FADIR test [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Numeric Rating Scale (NRS) pain during HEC test [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Hip flexion range of motion to first onset of pain (P1) [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Hip external rotation range of motion to first onset of pain (P1) [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Hip internal rotation range of motion to first onset of pain (P1) [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Hip function and quality of life (Hip Outcome Tool-12, iHOT-12Sv) [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]
  • Adverse events [Time frame: Baseline (T0), 7 days (T1), and 4 weeks after T1 (T2)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Previous hip surgery
  • Moderate or severe hip osteoarthritis (diagnosed radiographically)
  • Neurological pathology affecting the lower limb
  • Dominant lumbar spine pathology
  • Active rheumatic or systemic inflammatory diseases
  • Any contraindication to percutaneous electrolysis
  • Belonephobia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Fisioterapia La Moraleja — Alcobendas

Identifiers

NCT: NCT07548034 · CdEi95

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗