ACL InjuryNMPeLCANCT05606250
Ultrasound-guided Percutaneous Neuromodulation in Anterior Cruciate Reconstruction
A study testing Ultrasound-Guided Percutaneous Neuromodulation in people with ACL Injury, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Ultrasound-Guided Percutaneous Neuromodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 who have undergone surgery for an anterior cruciate ligament (ACL) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.).
- have pain or loss of sensitivity in the operated knee and that they have signed the informed consent.
Who cannot join
- Subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy.
- Subjects consuming analgesics.
- Subjects with belonephobia or insurmountable fear of needles
- History of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus.
- Subjects with a history of neurological or orthopedic disorders
- Subjects with bilateral symptoms.
- Subjects with epilepsy, pacemaker or pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Ultrasound-guided Percutaneous Neuromodulation Technique in Post-surgical Anterior Cruciate Ligament Patients
The objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament.
Read the detailed description
After being informed about the study and the potential risks, all subjects who accept the study and give their informed consent in writing, the subjects will participate in a randomized, longitudinal and prospective clinical trial divided into two groups (control group and experimental group) with the main objective of demonstrating that the ultrasound-guided percutaneous neuromodulation technique is effective for the treatment of pain in subjects undergoing surgery for the anterior cruciate ligament.
Subjects belonging to the control group will perform a physiotherapy protocol and those belonging to the experimental group will undergo two interventions of the ultrasound-guided percutaneous neuromodulation technique combined with the physiotherapy protocol. The same number of measurements will be performed on all subjects.
- Conditions
- ACL Injury
- Being tested
- Ultrasound-Guided Percutaneous Neuromodulation
- Keywords
- percutaneous neuromodulation, femoral nerve, ultrasound, acl reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Percutaneous NeuromodulationOther
Ultrasound guided percutaneous neuromodulation in femoral nerve. Patients were placed in supine lying with the anterior aspect of the hip uncovered. The intervention consisted of the application of a biphasic square wave electric current, with a frequency of 2 Hz, a phase duration of 250μs, and a maximum tolerable intensity to cause an exacerbated muscle contraction for 15minutes in total
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy protocol | No intervention | The physiotherapy protocol is based on manual therapy (passive joint mobilization), myofascial work, active exercise, high intensity neuromuscular electrical stimulation and cryotherapy. |
| Ultrasound-Guided Percutaneous Neuromodulation | Experimental | Ultrasound-guided percutaneous neuromodulation (e-NMP) is the electrical stimulation by means of a needle with ultrasound guidance of a peripheral nerve at some point in its course or of a muscle at a motor point, with a therapeutic purpose.
The application of the stimulation is carried out with a puncture needle accompanied by a low or medium frequency electrical current.
In e-MPN, a sensory and/or motor response is sought when the peripheral nerve is stimulated, and a motor response is achieved by stimulating the motor point (uncontrolled exaggerated response that normalizes after the application of the technique). Receives: Other: Ultrasound-Guided Percutaneous Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain through the visual analogue scale in 12 weeks
It allows pain intensity to be measured with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at whose ends are the extreme expressions of a symptom. Absence or less intensity is located on the left and greater intensity on the right. The patient is asked to mark the point on the line that indicates the intensity and it is measured with a millimeter ruler.
This variable will be measured with a numerical value from 1 to 10.
Measured: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Secondary outcomes (7)
Changes in DN4 scale en 12 weeks
The DN4 questionnaire consists of a total of 10 items grouped into 4 sections. The first seven elements are related to the quality of pain (burning, painful cold, electric shocks) and its association with abnormal sensations (pins and needles, tingling, numbness, itching). The other 3 items are related to the neurological examination in the painful area (tactile hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive element and a score of 0 to each negative element. The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
This variable will be measured with a numerical value from 1 to 10.
Measured: Before treatment / intervention and week 12.
Changes in LEFS scale in 12 weeks
measure the patient's baseline function, ongoing progress, and functional outcomes. This scale consists of 20 items, and the final score must be between 0 and 80. Items are rated on a 5-point scale, from 0 (extreme difficulty/ inability to perform the activity) to 4 (no difficulty).
This variable will be measured with a numerical value from 1 to 80.
Measured: Before treatment / intervention and week 12.
Changes in range of movement in 12 weeks.
With goniometry, the patient's flexion and extension will be measured. This variable will be reflected with a numerical value and angle degrees.
Measured: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Changes in pressure pain threshold in 12 weeks
Pressure pain threshold (PPT) was assessed with an analog algometer. One point on the epicondyle and five points on both knees (vastus lateralis, vastus medialis, patellar tendon, quadriceps tendon, and hamstring) were evaluated.
PPT points: (1) 10 cm lateral to the midpoint of the superior border of the patella; (2) 3 cm medial to the midpoint of the superior border of the patella; (3) midway between the inferior border of the patella and the tibial tuberosity; (4) 3 cm proximal to the superior border of the patella; and (5) 3 cm medial to the tibial tuberosity, at the insertion of pes anserinus.
When the individual reported a change in the sensation of pressure, the value indicated on the algometer was recorded. The subject did not receive information about the values obtained.
This variable will be reflected with numerical values. The PPT is expressed in kg/m^2 and was measured with an analog algometer.
Measured: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Changes in heart rate variability in 12 weeks
The intervals between successive heartbeats (RR intervals) 2 (HRV) domains to detect changes in HRV Time domain (non-spectral): average RR intervals (ms); RMSSD (ms): the square root of the mean value of the sum of the squared differences of all successive R-R intervals; LRMSSD (ms): logarithm of the square root of the mean value of the sum of the squared differences of all successive R-R intervals: SDNN (ms): the standard deviation of the interval between beats from which artifacts were removed (NN); and PNN50: the percentage of differences between adjacent normal R-R intervals of more than 50 ms.
Frequency domain / spectral measurements (spectral) (HF) and (LF) (ms). minimum, maximum and average heart rate. The subject will be seated for a period of two minutes and thirty seconds. The data will be collected with the BERRY KING HEARTBEAT 2 heart rate meter, and the data will be record.This variable will be reflected with numerical values.
Measured: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Changes in dynamometry in 12 weeks.
Dynamometry will be used to assess strength. This variable will be measured with a digital hand dynamometer called the Activ force 2 Digital Dynamometer. The patient will be seated on the stretcher and will actively do three isometric extensions with a 90º angle of knee flexion. This test will be carried out and the maximum extension force data will also be collected between the three knee extensions.
This variable will be reflected with numerical values.
Measured: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Body Mass Index
weight and height will be combined to report BMI in kg/m^2
Measured: Before treatment / intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start20 Jan 2022
- Primary completion20 Apr 2022
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies 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
- Model description
- Control group: The subjects will receive physiotherapy treatment and the experimental group will receive combined treatment of physiotherapy and ultrasound-guided percutaneous neuromodulation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Romero Morales, PT, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606250
- Sponsor's protocol ID
- h8yucsdh
- Acronym
- NMPeLCA
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPDs collected all IPDs underlying the results of a post
Publications
De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.
PubMed 34063673De-la-Cruz-Torres B, Carrasco-Iglesias C, Minaya-Munoz F, Romero-Morales C. Crossover effects of ultrasound-guided percutaneous neuromodulation on contralateral hamstring flexibility. Acupunct Med. 2021 Oct;39(5):512-521. doi: 10.1177/0964528420920283. Epub 2020 May 13.
PubMed 32403999Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.
PubMed 30160335San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.
PubMed 33876885Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7.
PubMed 28086940Caballero-Lopez J, Navarro-Santana M, Almazan-Polo J, Garcia-Sanz F, Diaz-Arribas MJ, Minaya-Munoz F, Romero-Morales C. Short-term effects of percutaneous electrical nerve stimulation on pain and muscle function in patients undergoing anterior cruciate ligament surgery: a randomized clinical trial. Front Rehabil Sci. 2025 Apr 29;6:1501703. doi: 10.3389/fresc.2025.1501703. eCollection 2025.
PubMed 40365171
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Ultrasound-guided Percutaneous Neuromodulation Technique in Post-surgical Anterior Cruciate Ligament Patients
- ClinicalTrials.gov ID
- NCT05606250
- Acronym / sponsor ID
- NMPeLCA / h8yucsdh
- Conditions
- ACL Injury
- Keywords
- percutaneous neuromodulation, femoral nerve, ultrasound, acl reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 4 Nov 2022 (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 objective of the study is to demonstrate the efficacy of the ultrasound-guided percutaneous neuromodulation technique in the femoral nerve in patients who underwent surgery for the anterior cruciate ligament.
Detailed description
After being informed about the study and the potential risks, all subjects who accept the study and give their informed consent in writing, the subjects will participate in a randomized, longitudinal and prospective clinical trial divided into two groups (control group and experimental group) with the main objective of demonstrating that the ultrasound-guided percutaneous neuromodulation technique is effective for the treatment of pain in subjects undergoing surgery for the anterior cruciate ligament.
Subjects belonging to the control group will perform a physiotherapy protocol and those belonging to the experimental group will undergo two interventions of the ultrasound-guided percutaneous neuromodulation technique combined with the physiotherapy protocol. The same number of measurements will be performed on all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Control group: The subjects will receive physiotherapy treatment and the experimental group will receive combined treatment of physiotherapy and ultrasound-guided percutaneous neuromodulation.
| Arm | Type | Receives |
|---|---|---|
| Physical therapy protocol | No intervention | –The physiotherapy protocol is based on manual therapy (passive joint mobilization), myofascial work, active exercise, high intensity neuromuscular electrical stimulation and cryotherapy. |
| Ultrasound-Guided Percutaneous Neuromodulation | Experimental | Other: Ultrasound-Guided Percutaneous NeuromodulationUltrasound-guided percutaneous neuromodulation (e-NMP) is the electrical stimulation by means of a needle with ultrasound guidance of a peripheral nerve at some point in its course or of a muscle at a motor point, with a therapeutic purpose. The application of the stimulation is carried out with a puncture needle accompanied by a low or medium frequency electrical current. In e-MPN, a sensory and/or motor response is sought when the peripheral nerve is stimulated, and a motor response is achieved by stimulating the motor point (uncontrolled exaggerated response that normalizes after the application of the technique). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects aged between 18 and 55 years who have undergone surgery for an anterior cruciate ligament (ACL) in a period of time between 2 and 6 weeks of evolution with or without meniscal injury (meniscal regularization / meniscal suture / meniscectomy, etc.).
- have pain or loss of sensitivity in the operated knee and that they have signed the informed consent.
Key exclusion criteria (7 listed)
- Subjects with chronic joint disease; prosthesis or osteosynthesis in the intervention area, as well as heart disease, neoplasia and coagulopathy.
- Subjects consuming analgesics.
- Subjects with belonephobia or insurmountable fear of needles
- History of lumbar pathology (lumbar hernia/protrusion) due to possible involvement of the lumbar plexus.
- Subjects with a history of neurological or orthopedic disorders
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 |
|---|---|---|
| Ultrasound-Guided Percutaneous NeuromodulationUltrasound guided percutaneous neuromodulation in femoral nerve. Patients were placed in supine lying with the anterior aspect of the hip uncovered. The intervention consisted of the application of a biphasic square wave electric current, with a frequency of 2 Hz, a phase duration of 250μs, and a maximum tolerable intensity to cause an exacerbated muscle contraction for 15minutes in total | Other | Ultrasound-Guided Percutaneous Neuromodulation |
Primary outcome
Changes in pain through the visual analogue scale in 12 weeks
Time frame: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
It allows pain intensity to be measured with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at whose ends are the extreme expressions of a symptom. Absence or less intensity is located on the left and greater intensity on the right. The patient is asked to mark the point on the line that indicates the intensity and it is measured with a millimeter ruler. This variable will be measured with a numerical value from 1 to 10.
7 secondary outcomes
Changes in DN4 scale en 12 weeks
Time frame: Before treatment / intervention and week 12.
Changes in LEFS scale in 12 weeks
Time frame: Before treatment / intervention and week 12.
Changes in range of movement in 12 weeks.
Time frame: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Changes in pressure pain threshold in 12 weeks
Time frame: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Changes in heart rate variability in 12 weeks
Time frame: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Changes in dynamometry in 12 weeks.
Time frame: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,
Body Mass Index
Time frame: Before treatment / intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 34063673De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.
- Background: PubMed 32403999De-la-Cruz-Torres B, Carrasco-Iglesias C, Minaya-Munoz F, Romero-Morales C. Crossover effects of ultrasound-guided percutaneous neuromodulation on contralateral hamstring flexibility. Acupunct Med. 2021 Oct;39(5):512-521. doi: 10.1177/0964528420920283. Epub 2020 May 13.
- Background: PubMed 30160335Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.
- Background: PubMed 33876885San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.
- Background: PubMed 28086940Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7.
- Derived from this study: PubMed 40365171Caballero-Lopez J, Navarro-Santana M, Almazan-Polo J, Garcia-Sanz F, Diaz-Arribas MJ, Minaya-Munoz F, Romero-Morales C. Short-term effects of percutaneous electrical nerve stimulation on pain and muscle function in patients undergoing anterior cruciate ligament surgery: a randomized clinical trial. Front Rehabil Sci. 2025 Apr 29;6:1501703. doi: 10.3389/fresc.2025.1501703. eCollection 2025.
- Individual participant dataSharing planned: Yes. all IPDs collected all IPDs underlying the results of a post
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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. This study is not recruiting at the moment.
Carlos Romero Morales, PT principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Percutaneous Neuromodulation in people with ACL Injury, run by Universidad Europea de Madrid 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 21 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in pain through the visual analogue scale in 12 weeks (time frame: Before treatment, immediately after treatment. Before treatment at week 1 after the first measurement, immediately after treatment at week 1 after the first measurement. Week 4 from the first measurement. Week 12 from the first measurement,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606250, which also lists 6 linked publications.
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 21 Mar 2024.