Effectiveness of Stimulation on the Sciatic Nerve in ACLR

NCT07569796 | Recruiting

• 1 other identifier: CE102505
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

PENS; ACL surgery; ACL rehabilitation; Sciatic Nerve

Outcome Measures

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.

  5 weeks after surgery

Secondary Outcomes (5)

• Surface Electromyography of the Hamstring Musculature

  5 weeks after surgery

• Postsurgery Pain

  5 weeks after surgery

• Thigh Circumference Measurement

  5 weeks after surgery

• Intra-Articular Effusion

  5 weeks after surgery

• Knee Range of Motion

  5 weeks after surgery

Study Arms (2)

Control Group

NO INTERVENTION

Experimental Group

EXPERIMENTAL

Procedure: Experimental Group

Interventions

Experimental Group PROCEDURE

Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Clinica CEMTRO, Montecarmelo, Madrid

Madrid, Madrid, 28049, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: May 6, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)