Anterior Cruciate Ligament Reconstruction RehabilitationNCT07569796
Effectiveness of Stimulation on the Sciatic Nerve in ACLR
A study testing Experimental Group in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universidad de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Experimental Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Chronic or rheumatic joint disease
- Central nervous system disorder
- Heart disease (pacemaker)
- Neoplasms
- Epilepsy
- Coagulopathies (use of anticoagulants)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clinica CEMTRO, Montecarmelo, Madrid
Madrid, Madrid, 28049
Adrián Cases Sebastià, Physiotherapist, 609906468 ext. +34, adriancasese@gmail.com
Javier Reina Abellán, PhD, 656887703 ext. +34, jreina@ucam.edu
About this study
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".
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.
Read the 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.
- Being tested
- Experimental Group
- Keywords
- PENS, ACL surgery, ACL rehabilitation, Sciatic Nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupProcedure or surgery
Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Experimental Group | Experimental | Not described Receives: Procedure: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks after surgery
Secondary outcomes (5)
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.
Measured: 5 weeks after surgery
Postsurgery Pain
NRS scale: 0 = no pain and 10 = the worst pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Reina Abellan; PhD, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569796
- Sponsor's protocol ID
- CE102505
- Status last verified
- May 2026
- First submitted
- 2 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT07569796
- Acronym / sponsor ID
- CE102505
- Keywords
- PENS, ACL surgery, ACL rehabilitation, Sciatic Nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Experimental Group | Experimental | Procedure: Experimental Group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- Chronic or rheumatic joint disease
- Central nervous system disorder
- Heart disease (pacemaker)
- Neoplasms
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupPercutaneous Electrical Nerve Stimulation on the Sciatic Nerve | Procedure or surgery | Experimental Group |
Primary outcome
Maximal Isometric Strength of the Hamstring Musculature
Time frame: 5 weeks after surgery
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 secondary outcomes
Surface Electromyography of the Hamstring Musculature
Time frame: 5 weeks after surgery
Postsurgery Pain
Time frame: 5 weeks after surgery
Thigh Circumference Measurement
Time frame: 5 weeks after surgery
Intra-Articular Effusion
Time frame: 5 weeks after surgery
Knee Range of Motion
Time frame: 5 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Isometric Strength of the Hamstring Musculature (time frame: 5 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.