- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07569796
Effectiveness of Stimulation on the Sciatic Nerve in ACLR
"Effectiveness of Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve in Patients Undergoing Surgical Reconstruction of the Anterior Cruciate Ligament. A Randomized Clinical Trial".
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Madrid
-
Madrid, Madrid, Spanien, 28049
- Rekrutierung
- Clinica CEMTRO, Montecarmelo, Madrid
-
Kontakt:
- Adrián Cases Sebastià, Physiotherapist
- Telefonnummer: +34 609906468
- E-Mail: adriancasese@gmail.com
-
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
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
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
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
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CE102505
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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