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Effectiveness of Stimulation on the Sciatic Nerve in ACLR

4. Mai 2026 aktualisiert von: Javier Reina Abellan; PhD, Universidad de Murcia

"Effectiveness of Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve in Patients Undergoing Surgical Reconstruction of the Anterior Cruciate Ligament. A Randomized Clinical Trial".

After randomization, the control group will receive conventional physiotherapy, including manual therapy and therapeutic exercise for ACL rehabilitation. The first experimental group will undergo percutaneous electrical nerve stimulation of the sciatic nerve, while the second experimental group will receive a placebo stimulation. Both interventions aim to improve isometric strength, muscle activation, joint range of motion, and thigh circumference, as well as reduce pain and intra-articular effusion. The procedure involves needle insertion into the sciatic nerve epineurium, placement of a surface electrode on the hamstrings, and connection to an electrostimulator.

Studienübersicht

Detaillierte Beschreibung

After randomization, participants in the control group will undergo only the conventional physiotherapy program, which consists of manual therapy and therapeutic exercise for the rehabilitation of the anterior cruciate ligament. The first experimental group will receive a percutaneous electrical nerve stimulation protocol applied to the sciatic nerve, consisting of 10 cycles of 10 seconds of electrical current followed by 10 seconds of rest, with the intensity adjusted to the patient's tolerance threshold. The second experimental group will follow the same procedure but with a placebo stimulation. The interventions aim to improve isometric strength, muscle activation, joint range of motion, and thigh circumference, while also reducing pain and intra-articular effusion. The experimental procedure involves inserting a needle into the epineurium of the sciatic nerve after disinfecting the area and placing a surface electrode on the hamstring muscles, followed by connecting the needle to an electrostimulator.

Studientyp

Interventionell

Einschreibung (Geschätzt)

62

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Madrid
      • Madrid, Madrid, Spanien, 28049
        • Rekrutierung
        • Clinica CEMTRO, Montecarmelo, Madrid
        • Kontakt:
        • Kontakt:
          • Javier Reina Abellán, PhD
          • Telefonnummer: +34 656887703
          • E-Mail: jreina@ucam.edu
        • Hauptermittler:
          • Adrián Cases Sebastià, Physiotherapist
        • Unterermittler:
          • Luis Blanco López, Physiotherapist
        • Unterermittler:
          • Javier Reina Abellán, PhD
        • Unterermittler:
          • Pedro Guillén García, PhD
        • Unterermittler:
          • Iván Nacher Moltó, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Use of the Semitendinous and Gracilis tendons for ACL Reconstruction
  • Joint Range of Motion greater than or equal to 90
  • Primary ACL injury in the leg to be treated

Exclusion Criteria:

  • Chronic or rheumatic joint disease
  • Central nervous system disorder
  • Heart disease (pacemaker)
  • Neoplasms
  • Epilepsy
  • Coagulopathies (use of anticoagulants)
  • History of spinal surgery or lumbar disease
  • History of neurological disorders
  • Prosthesis or osteosynthesis in the operated leg
  • Structural discrepancy in lower-limb length
  • Belonephobia (overwhelming fear of needles)
  • Neuropathic pain or bilateral symptoms
  • Use of analgesics
  • Quadriceps tendon graft harvest
  • Body mass index <20 or >30 kg/m²
  • Acute muscle injuries
  • Knee joint instability
  • Acute joint inflammation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimentelle Gruppe
Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve
Kein Eingriff: Kontrollgruppe

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximal Isometric Strength of the Hamstring Musculature
Zeitfenster: 5 weeks after surgery

Maximal Isometric Strength of the Hamstring Musculature

This was recorded with the patient in a prone position, with the knee flexed at 90 degrees and the ankle in plantar flexion.

The patient was instructed to perform an isometric knee flexion against a Lafayette hand-held dynamometer, positioned at the level of the Achilles tendon.

Three repetitions were recorded and measured in Newtons, with a 60-second rest interval between repetitions.

5 weeks after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Surface Electromyography of the Hamstring Musculature
Zeitfenster: 5 weeks after surgery

This variable was assessed in three different positions. The first position involved the patient lying prone with the knee flexed at 90 degrees and the ankle in plantar flexion.

In the second position, the patient was seated at the edge of the examination table with the trunk upright, the hip flexed at 90 degrees, and the knee flexed at 90 degrees, with the ankle in plantar flexion.

In the third position, the patient stood in front of the examination table with the injured leg supported on it. The leg was positioned with 90 degrees of hip flexion, 30 degrees of knee flexion, and the ankle in dorsiflexion.

The percentage of activation of the biceps femoris and semitendinosus muscles was recorded, as well as the mean activation ratio of these muscles and the peak activation of both. The latter two variables were measured in microvolts.

Three repetitions of 5 seconds of activation were performed, with a 60-second rest interval between each repetition.

5 weeks after surgery
Postsurgery Pain
Zeitfenster: 5 weeks after surgery
NRS scale: 0 = no pain and 10 = the worst pain
5 weeks after surgery
Thigh Circumference Measurement
Zeitfenster: 5 weeks after surgery

Thigh circumference was measured using a measuring tape, a validated tool with high inter- and intra-rater reliability in patients with anterior cruciate ligament (ACL) reconstruction.

The patient was positioned in a seated posture with the legs hanging off the examination table. The evaluator stood on the ipsilateral side of the operated limb to ensure unobstructed access.

The operated knee was maintained in maximal extension, and the patient was instructed to remain relaxed and avoid any contraction of the thigh musculature that could bias the measurement.

The evaluator then used the measuring tape to encircle the thigh at a point 10 cm above the superior pole of the patella and recorded the circumference.

5 weeks after surgery
Intra-Articular Effusion
Zeitfenster: 5 weeks after surgery

Intra-articular effusion was assessed with the patient in a supine position and the knee in extension. The patient was required to remain relaxed to allow accurate assessment of post-surgical joint effusion using the "Stroke test." During this test, the evaluator performed sweeping strokes with the hands from medial to lateral and vice versa, observing the behavior of the effusion and whether it returned to the medial side.

This test is graded on a 0-3 scale: 0 indicates no detectable effusion; 1 indicates a measurable fluid wave with a single maneuver; 2 indicates visible fluid with slight pressure; and 3 indicates a large effusion without the need for pressure.

This method is validated by the IKDC 2000 (International Knee Documentation Committee) and is widely used in research studies.

5 weeks after surgery
Knee Range of Motion
Zeitfenster: 5 weeks after surgery

Active and passive knee range of motion was measured using a universal manual goniometer, a highly validated tool commonly used in clinical physiotherapy practice.

The patient was positioned supine for accurate measurement. The greater trochanter was identified, and the patient was asked to actively flex the knee by sliding the heel along the table without using the hands.

The evaluator stabilized the operated limb with the caudal hand and placed the axis of the goniometer over the lateral femoral condyle. The proximal arm was aligned with the midline of the thigh toward the greater trochanter, and the distal arm with the midline of the leg toward the lateral malleolus.

For knee extension, the patient remained in a supine position with the heel, gastrocnemius, and hamstring musculature supported on the table. The patient was then asked to perform active extension, and the goniometer was positioned using the same anatomical landmarks to determine both passive and active extension.

5 weeks after surgery

Mitarbeiter und Ermittler

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

2. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • CE102505

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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