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".

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
• Intervention / Treatment: Procedure: Experimental Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28049
      • Recruiting
      • Clinica CEMTRO, Montecarmelo, Madrid
      • Contact: Adrián Cases Sebastià, Physiotherapist; Phone Number: +34 609906468; Email: adriancasese@gmail.com
      • Contact: Javier Reina Abellán, PhD; Phone Number: +34 656887703; Email: jreina@ucam.edu
      • Principal Investigator: Adrián Cases Sebastià, Physiotherapist
      • Sub-Investigator: Luis Blanco López, Physiotherapist
      • Sub-Investigator: Javier Reina Abellán, PhD
      • Sub-Investigator: Pedro Guillén García, PhD
      • Sub-Investigator: Iván Nacher Moltó, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Procedure: Experimental Group; Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Isometric Strength of the Hamstring Musculature	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface Electromyography of the Hamstring Musculature	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	NRS scale: 0 = no pain and 10 = the worst pain	5 weeks after surgery
Thigh Circumference Measurement	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	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	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

Collaborators and Investigators

• Sponsor: Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Sciatic Nerve; ACL rehabilitation; ACL surgery; PENS
• Other Study ID Numbers: CE102505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No