Effectiveness of Stimulation on the Sciatic Nerve in ACLR

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversidad de Murcia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Chronic or rheumatic joint disease

Central nervous system disorder

Heart disease (pacemaker)

Neoplasms

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental Group

    Procedure/Surgery

    Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 weeks after surgery

Secondary outcomes

1

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.

Time frame
5 weeks after surgery
2

Postsurgery Pain

NRS scale: 0 = no pain and 10 = the worst pain

Time frame
5 weeks after surgery
3

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.

Time frame
5 weeks after surgery
4

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.

Time frame
5 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.