Sciatic nerve stimulation to help ACL reconstruction recovery
"Effectiveness of Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve in Patients Undergoing Surgical Reconstruction of the Anterior Cruciate Ligament. A Randomized Clinical Trial".
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universidad de Murcia Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07569796 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madrid, Madrid
- Clinica CEMTRO, Montecarmelo, Madrid — Madrid, Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.