Clinical trial Recruiting at 1 site Interventional Ages 18 to 60

Sciatic nerve stimulation to help ACL reconstruction recovery

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

Run by Universidad de Murcia · NCT07569796 · Data updated 2026-11-12

This will test whether adding needle electrical stimulation of the sciatic nerve to standard physiotherapy helps people recovering from ACL reconstruction with hamstring grafts.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment62 (estimated)
SponsorUniversidad de Murcia
Academic / other
Locations1 site (Madrid, Madrid)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedMay 6, 2026
Trial IDNCT07569796 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults who had a primary ACL reconstruction using semitendinosus and gracilis (hamstring) grafts, have at least 90° knee range of motion, and meet the study's BMI and health inclusion criteria.

Probably not a fit

Patients with pacemakers, active anticoagulation, neurological disorders, needle phobia, or other listed exclusions (for example BMI outside 20–30 kg/m²) are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are randomized to receive conventional physiotherapy alone, physiotherapy plus percutaneous electrical nerve stimulation (PENS) of the sciatic nerve, or physiotherapy plus placebo stimulation. The active PENS procedure places a needle into the sciatic nerve epineurium, applies a surface electrode on the hamstrings, and delivers 10 cycles of 10 seconds on and 10 seconds off at the patient's tolerance. Outcome measures include isometric strength, muscle activation, knee range of motion, thigh circumference, pain, and intra-articular effusion during rehabilitation. The placebo arm follows the same procedure without active current to maintain blinding.

Why it matters

Potential benefit: If successful, the technique could speed functional recovery by improving muscle strength and activation while reducing pain and joint swelling after ACL reconstruction.

How similar studies have gone: Some small studies of peripheral nerve stimulation after knee surgery report improved muscle activation and pain relief, but percutaneous sciatic epineurium stimulation specifically for ACL rehabilitation is relatively novel and not yet widely confirmed.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Clinica CEMTRO, Montecarmelo, Madrid
    Madrid, Madrid, Spain
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.