Anterior Cruciate Ligament Reconstruction RehabilitationNCT06910150
Effectiveness of a Session of Analgesic Electrostimulation (Invasive and Non-invasive) Applied to the Quadriceps Muscle in Patients After Knee Surgery.
A study testing Non-invasive analgesic electrostimulation and Invasive analgesic electrostimulation in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The anterior cruciate ligament (ACL) injury is one of the most prevalent injuries in the musculoskeletal system. Consequently, its surgical reconstruction is among the most commonly performed procedures in current clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Non-invasive analgesic electrostimulation and Invasive analgesic electrostimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2025to 25 Feb 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged between 18 and 55 years, regardless of gender.
- Subjects who have undergone surgical ACL reconstruction within the past six weeks, with or without additional procedures on one or both menisci due to their high concomitance, and with or without Lemaire reinforcement in the form of extra-articular lateral tenodesis.
- Subjects experiencing pain in the operated knee.
- Voluntary signing of the informed consent form for the study.
Who cannot join
- Contraindications for invasive therapies:
- Subjects with chronic joint pathology.
- Subjects with prostheses or osteosynthesis in the affected lower limb.
- Subjects with heart disease.
- Subjects with neoplasms.
- Subjects with coagulopathies.
Show all 26Show fewer
- Subjects with epilepsy.
- Subjects with pacemakers.
- Pregnant patients.
- Subjects with belonephobia (severe fear of needles).
- Subjects with neuropathic pain.
- Subjects with central nervous system disorders.
- Subjects with a history of neurological disorders.
- Subjects with a history of lumbar hernia or protrusion due to a possible involvement of the lumbar plexus.
- Subjects with a history of spinal surgery.
- Subjects presenting any bilateral symptoms.
- Subjects with a BMI greater than 30 kg/m².
- Subjects taking analgesic medication.
- Subjects receiving any alternative treatment not proposed in this study, which could alter the results.
- Subjects scoring above 37.5 points on the "Personal Psychological Apprehension Scale in Physiotherapy".
- Contraindications for dynamometric measurement:
- Subjects with acute quadriceps muscle injury.
- Subjects with joint instability.
- Subjects with acute joint inflammation.
- Subjects who voluntarily withdraw from the study.
- Subjects absent for any measurement session.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immediate Effectiveness of a Single Session of Analgesic Electrostimulation on the Femoral Quadriceps in Patients After Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.
The anterior cruciate ligament (ACL) injury is one of the most prevalent injuries in the musculoskeletal system. Consequently, its surgical reconstruction is among the most commonly performed procedures in current clinical practice.
The aim of this clinical trial is to investigate if the application of a single session of electrical currents to the quadriceps muscle can reduce pain in individuals who have undergone ACL surgery. Additionally, the trial will assess whether this intervention increases the pressure pain threshold, mobility, strength and functionality of the operated knee, as well as improving the participant's quality of life. Effusion and edema of the operated knee will also be measured.
Read more
Participants in this clinical trial will be randomly assigned to three study groups: one control group and two experimental groups.
All participants will undergo a conventional physiotherapy program for knee rehabilitation. This program includes manual therapy with a physiotherapist and exercises aimed at strengthening the CORE, hip and knee muscles.
Participants in the first experimental group will receive an additional session of superficial (non-invasive) electrical currents applied to the quadriceps muscle of the operated knee.
Participants in the second experimental group will receive an additional session of invasive electrical currents applied to the quadriceps muscle of the operated knee.
Each patient will be assessed four times: before the intervention, immediately after the intervention, and 1 and 7 days post-intervention. Functionality of the operated knee and quality of life will only be assessed before the intervention and 7 days post-intervention using self-reported scales.
- Being tested
- Non-invasive analgesic electrostimulation, Invasive analgesic electrostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive analgesic electrostimulationProcedure or surgery
Also called TENS (Transcutaneous Electrical Nerve Stimulation)
A single session of non-invasive analgesic electrostimulation is applied to the motor points of the vastus medialis and vastus lateralis muscles of the quadriceps femoris in patients who had undergone anterior cruciate ligament reconstruction. A biphasic, symmetrical, square-wave current is used at a frequency of 100 Hz, a pulse width of 200 μs, and an intensity adjusted to the patient's pain threshold, applied for 30 minutes.
Invasive analgesic electrostimulationProcedure or surgery
Also called LTP protocol (long-term potentiation)
A single session of invasive analgesic electrostimulation is applied to a motor point of the vastus medialis of the quadriceps femoris in patients who had undergone anterior cruciate ligament reconstruction. A biphasic, symmetrical, square-wave current is used at a frequency of 100 Hz, a pulse width of 250 μs, and an intensity defined as perceptible to the patient but never painful (200 μA above the detection threshold for each subject).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants will only undergo a conventional physiotherapy rehabilitation program for anterior cruciate ligament rehabilitation. |
| Experimental Group 1 | Experimental | Participants will undergo a conventional anterior cruciate ligament rehabilitation physiotherapy program and receive a single session of analgesic transcutaneous electrical nerve stimulation (TENS). Receives: Procedure: Non-invasive analgesic electrostimulation |
| Experimental Group 2 | Experimental | Participants will undergo a conventional anterior cruciate ligament rehabilitation physiotherapy program and receive a single session of invasive analgesic electrostimulation (LTP, long-term potentiation). Receives: Procedure: Invasive analgesic electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with the Numeric Rating Scale (NRS). The patient reports their pain at the moment of measurement on a scale from 0 (no pain) to 10 (worst imaginable pain).
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in knee range of movement from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a manual universal goniometer.
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in knee pain threshold to pressure from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with an analog algometer (FPK 20).
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in maximum isometric quadriceps strength from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a portable handheld dynamometer Lafayette© (Lafayette Manual Muscle Tester, Lafayette Instruments, Lafayette, IN)
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in thigh muscle atrophy from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a flexible measuring tape.
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in knee intra-articular effusion from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed on the basis of bulge and dancing patella signs and reported as 3 (>60 cm3 - tight capsule), 2 (25-60 cm3 - visible), 1(<25 cm3 - palpable by smoothing out the joint capsule), or 0 (no effusion).
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in knee extra-articular edema from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a flexible measuring tape.
Measured: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Change in quality of life from baseline to seven days post-intervention.
Assessed with the self-reported scale "Anterior Cruciate Ligament - Quality of Life - Spanish".
Potential score: 0-3200. The higher the score, the better the patient's quality of life..
Measured: From baseline to seven days post-intervention.
Change in knee functionality from baseline to seven days post-intervention.
Assessed with the self-reported questionnaire "Lysholm Scale". Potential score: 0-100 points. The higher the score, the better the patient's functionality.
Measured: From baseline to seven days post-intervention.
Needle apprehension at baseline
Assessed with the self-reported questionnaire "Personal Psychological Apprehension Scale in Physiotherapy".
Potential score: 15-60 points. The higher the score, the worse the patient's situation.
If the participant scored higher than 37.5 points at baseline, they were excluded from the study (exclusion criteria).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start18 Feb 2025
- Primary completion18 Feb 2025
- Study completion25 Feb 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 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 Católica San Antonio de Murcia
- Investigators
- Luis Blanco-López, Physiotherapy, Principal investigator, Universidad Católica San Antonio de Murcia (UCAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910150
- Sponsor's protocol ID
- CE112417
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effectiveness of a Single Session of Analgesic Electrostimulation on the Femoral Quadriceps in Patients After Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06910150
- Acronym / sponsor ID
- CE112417
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 4 Apr 2025 (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.
The anterior cruciate ligament (ACL) injury is one of the most prevalent injuries in the musculoskeletal system. Consequently, its surgical reconstruction is among the most commonly performed procedures in current clinical practice.
The aim of this clinical trial is to investigate if the application of a single session of electrical currents to the quadriceps muscle can reduce pain in individuals who have undergone ACL surgery. Additionally, the trial will assess whether this intervention increases the pressure pain threshold, mobility, strength and functionality of the operated knee, as well as improving the participant's quality of life. Effusion and edema of the operated knee will also be measured.
Participants in this clinical trial will be randomly assigned to three study groups: one control group and two experimental groups.
All participants will undergo a conventional physiotherapy program for knee rehabilitation. This program includes manual therapy with a physiotherapist and exercises aimed at strengthening the CORE, hip and knee muscles.
Participants in the first experimental group will receive an additional session of superficial (non-invasive) electrical currents applied to the quadriceps muscle of the operated knee.
Participants in the second experimental group will receive an additional session of invasive electrical currents applied to the quadriceps muscle of the operated knee.
Each patient will be assessed four times: before the intervention, immediately after the intervention, and 1 and 7 days post-intervention. Functionality of the operated knee and quality of life will only be assessed before the intervention and 7 days post-intervention using self-reported scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants will only undergo a conventional physiotherapy rehabilitation program for anterior cruciate ligament rehabilitation. |
| Experimental Group 1 | Experimental | Procedure: Non-invasive analgesic electrostimulationParticipants will undergo a conventional anterior cruciate ligament rehabilitation physiotherapy program and receive a single session of analgesic transcutaneous electrical nerve stimulation (TENS). |
| Experimental Group 2 | Experimental | Procedure: Invasive analgesic electrostimulationParticipants will undergo a conventional anterior cruciate ligament rehabilitation physiotherapy program and receive a single session of invasive analgesic electrostimulation (LTP, long-term potentiation). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged between 18 and 55 years, regardless of gender.
- Subjects who have undergone surgical ACL reconstruction within the past six weeks, with or without additional procedures on one or both menisci due to their high concomitance, and with or without Lemaire reinforcement in the form of extra-articular lateral tenodesis.
- Subjects experiencing pain in the operated knee.
- Voluntary signing of the informed consent form for the study.
Key exclusion criteria (26 listed)
- Contraindications for invasive therapies:
- Subjects with chronic joint pathology.
- Subjects with prostheses or osteosynthesis in the affected lower limb.
- Subjects with heart disease.
- Subjects with neoplasms.
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 |
|---|---|---|
| Non-invasive analgesic electrostimulationAlso: TENS (Transcutaneous Electrical Nerve Stimulation)A single session of non-invasive analgesic electrostimulation is applied to the motor points of the vastus medialis and vastus lateralis muscles of the quadriceps femoris in patients who had undergone anterior cruciate ligament reconstruction. A biphasic, symmetrical, square-wave current is used at a frequency of 100 Hz, a pulse width of 200 μs, and an intensity adjusted to the patient's pain threshold, applied for 30 minutes. | Procedure or surgery | Experimental Group 1 |
| Invasive analgesic electrostimulationAlso: LTP protocol (long-term potentiation)A single session of invasive analgesic electrostimulation is applied to a motor point of the vastus medialis of the quadriceps femoris in patients who had undergone anterior cruciate ligament reconstruction. A biphasic, symmetrical, square-wave current is used at a frequency of 100 Hz, a pulse width of 250 μs, and an intensity defined as perceptible to the patient but never painful (200 μA above the detection threshold for each subject). | Procedure or surgery | Experimental Group 2 |
Primary outcome
Change in knee pain from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with the Numeric Rating Scale (NRS). The patient reports their pain at the moment of measurement on a scale from 0 (no pain) to 10 (worst imaginable pain).
Change in knee range of movement from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a manual universal goniometer.
Change in knee pain threshold to pressure from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with an analog algometer (FPK 20).
Change in maximum isometric quadriceps strength from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a portable handheld dynamometer Lafayette© (Lafayette Manual Muscle Tester, Lafayette Instruments, Lafayette, IN)
Change in thigh muscle atrophy from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a flexible measuring tape.
Change in knee intra-articular effusion from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed on the basis of bulge and dancing patella signs and reported as 3 (>60 cm3 - tight capsule), 2 (25-60 cm3 - visible), 1(<25 cm3 - palpable by smoothing out the joint capsule), or 0 (no effusion).
Change in knee extra-articular edema from baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.
Assessed with a flexible measuring tape.
Change in quality of life from baseline to seven days post-intervention.
Time frame: From baseline to seven days post-intervention.
Assessed with the self-reported scale "Anterior Cruciate Ligament - Quality of Life - Spanish". Potential score: 0-3200. The higher the score, the better the patient's quality of life..
Change in knee functionality from baseline to seven days post-intervention.
Time frame: From baseline to seven days post-intervention.
Assessed with the self-reported questionnaire "Lysholm Scale". Potential score: 0-100 points. The higher the score, the better the patient's functionality.
Needle apprehension at baseline
Time frame: At baseline
Assessed with the self-reported questionnaire "Personal Psychological Apprehension Scale in Physiotherapy". Potential score: 15-60 points. The higher the score, the worse the patient's situation. If the participant scored higher than 37.5 points at baseline, they were excluded from the study (exclusion criteria).
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 10 Dec 2025.
Related trials for Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
Recruiting
The Effect of Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
The Effect of Isokinetic Vs Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction
Knee Injuries
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.
Luis Blanco-López, Physiotherapy principal investigator
Universidad Católica San Antonio de Murcia (UCAM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive analgesic electrostimulation and Invasive analgesic electrostimulation 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 4 inclusion and 26 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: enrolling by invitation, as of the sponsor's last update on 10 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain from baseline to immediately after the intervention, as well as at one and seven days post-intervention. (time frame: From baseline to immediately after the intervention, as well as at one and seven days post-intervention.). The study lists 10 primary outcomes in all. 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 10 Dec 2025.