Arthrosis of the KneeTKANCT07032805
Study on Personalized Total Knee Arthroplasty (TKA) Rehabilitation Using Telemedicine and Psychoeducation
A study testing personalized outpatient rehabilitation treatment after TKA and standard outpatient rehabilitation treatment after TKA in people with Arthrosis of the Knee, run by Laura Belinda Rizzo at 1 site in Italy.
Trial summary
The aim of this clinical study is to evaluate the effectiveness of a telemedicine approach in improving treatment adherence and functional outcomes in patients recently underwent total knee replacement for primary osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Arthrosis of the Knee
- What is being tested?
- personalized outpatient rehabilitation treatment after TKA and standard outpatient rehabilitation treatment after TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 31 Oct 2025
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent unilateral total knee arthroplasty;
- Body Mass Index (BMI) < 35;
- Ability to stand on one leg;
- Absence of active known neurological or oncological diseases.
Who cannot join
- Post-traumatic or inflammatory knee osteoarthritis (OA);
- Valgus/varus deformity (hip-knee-ankle angle > or < 10°).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Presidio territoriale di recupero e riabilitazione funzionale "San Giovanni di Dio" Conssi welfare
Adelfia, Bari, 70071
About this study
Official title: Coping to Move Again: The Psychological Dimension of Tele-Supported Rehabilitation After Knee Arthroplasty - A Randomized Controlled Trial
The aim of this clinical study is to evaluate the effectiveness of a telemedicine approach in improving treatment adherence and functional outcomes in patients recently underwent total knee replacement for primary osteoarthritis. The study focuses on patients aged between 50 and 75 years, with a BMI below 35, and without known oncological or neurological conditions. Participants will receive a personalized rehabilitation program, including initial assessment, psychomotivational framing, and rehabilitation interventions based on telemedicine. The goal is to provide a framework for adopting more detailed and personalized rehabilitative strategies.The main research questions are:• Primary: pain reduction (VAS), physical function (WOMAC, KOOS).• Secondary: activities of daily living (Barthel index, mRS); psychobehavioral assessments (CEQ, PAM13, CG-PAM, COP-NIV); attitude towards technology (TAM); use of analgesics and walking aids.Sample size is estimated at 40 patients (20 per group), accounting for a 20% dropout rate, divided into:• Control group: standard outpatient rehabilitation with a personalized exercise program.• Study group: standard outpatient rehabilitation with a personalized exercise program plus telemonitoring via video calls. Procedures:• Recruitment and signing of informed consent; • Initial assessment (demographic data, baseline tests) and start of post-acute rehabilitation during hospitalization at T0;• Outpatient rehabilitation interventions with/without tele-rehabilitation support (twice weekly) at discharge, with follow-up assessments at T1 (1.5 months) and T2 (3 months);• Weekly recording of analgesic consumption through a dedicated diary;• Recording the date of discontinuation of walking aids.
Read the detailed description
To ensure quality and ethical standards in the design and implementation of our randomized clinical trial (RCT), we will apply the Helsinki criteria and the CONSORT checklist. All patients hospitalized for rehabilitation after total knee arthroplasty (TKA) at the San Giovanni di Dio Rehabilitation Center in Adelfia (BA) will be evaluated for eligibility to participate in a clinical study on primary symptomatic osteoarthritis (OA) of the knee between July and October 2025.Inclusion criteria (in addition to those already mentioned in the brief summary): •Ability to stand on one leg. Exclusion criteria: •Post-traumatic or inflammatory knee OA; •Valgus/varus deformity (hip-knee-ankle angle > or < 10°).The control group and the study group, after medical, physiotherapeutic, and psychological assessment, will receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be delivered in two physiotherapy sessions per day, each lasting 45 minutes, during the 22-25 days of hospitalization. Following discharge, participants will receive outpatient treatment consisting of two 45-minute sessions per week for three months at a physiotherapy clinic. The control group will follow this program as usual, while the study group will have the same program reinforced with home supervision via telemedicine. A physiotherapist, trained on the initial psychological assessments, will conduct teleconsultations using Zoom (with end-to-end encryption). Patient characteristics and outcome measures will be reported in aggregate form, as mean ± standard deviation for continuous variables and absolute frequencies (percentages) for categorical variables. Statistical analysis of outcomes will include testing the significance of differences. The two groups will be compared based on baseline characteristics and changes in outcomes. Data Profile: Since variables are non-normally distributed (Shapiro-Wilk test), the study uses non-parametric methods. Data is expressed as medians (IQR) or frequencies (%).
Baseline Comparisons: Groups are compared via the Mann-Whitney U test (continuous) and χ 2 or Fisher's exact tests (categorical). Longitudinal Analysis: Clinical outcomes over time (T0-T2) are evaluated using a non-parametric mixed-effects model to analyze time, group, and their interaction. Changes \& Correlations: Relative variation is calculated as Δ=(T 2-T0)/T0. Its relationship with baseline psychological scores is assessed via Spearman's correlation. Thresholds: Analyses are performed in R (v4.2), using a significance threshold of p<0.05.
- Conditions
- Arthrosis of the Knee
- Being tested
- personalized outpatient rehabilitation treatment after TKA, standard outpatient rehabilitation treatment after TKA
- Keywords
- telemedicine, primary osteoarthritis, rehabilitation, discontinuation of walking aids, Reduction of pain, physical function, psycho-behavioral assessments, attitude toward technology, use of analgesics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized outpatient rehabilitation treatment after TKAProcedure or surgery
personalized outpatients rehabilitation treatment after TKA, including psychomotivational framing, and telemedicine-based rehabilitation interventions
standard outpatient rehabilitation treatment after TKAProcedure or surgery
standard outpatient rehabilitation treatment after TKA
| Study group | Role | What they receive |
|---|---|---|
| outpatient rehabilitative treatment plus tele-rehabilitation | Experimental | The study group will undergo medical, physiotherapeutic, and psychological assessment. They will then receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and developing walking ability. This will be delivered in two daily physiotherapy sessions, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue outpatient treatment with two 45-minute sessions per week for three months at a physiotherapy clinic. Additionally, they will receive home supervision from a physiotherapist via telemedicine (video calls using Zoom with encryption), trained on the patient's initial issues identified through psychological evaluation. Receives: Procedure: personalized outpatient rehabilitation treatment after TKA |
| Standard outpatient rehabilitative treatment | Active comparator | The control group will undergo medical, physiotherapeutic, and psychological assessments. They will then receive treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be administered in two physiotherapy sessions per day, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue with outpatient physiotherapy consisting of two 45-minute sessions per week for three months at an outpatient physiotherapy clinic. Receives: Procedure: standard outpatient rehabilitation treatment after TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Pain assessment)
We will use the VAS (Visual Analogue Scale) to quickly and reliably determine the pain perceived by the patient. The VAS (Visual Analogue Scale) consists of a horizontal line 10 centimeters long, with two endpoints representing opposite levels of sensation. Zero is at the extreme left, indicating "No pain," and ten is at the extreme right, representing "The worst pain imaginable." The patient subjectively expresses their perception of pain by indicating a point on the line.
Measured: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Western Ontario and McMaster Universities Arthritis Index (Physical function)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a patient-reported outcome questionnaire that assesses symptoms and activity limitations in osteoarthritis or following joint replacement surgery. It evaluates the severity of pain, joint stiffness, and physical function with 24 questions, each using a Likert scale ranging from 0 (no symptoms) to 4 (high intensity or difficulty);
Measured: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Knee Injury and Osteoarthritis Outcome Score (Knee function)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire that assesses symptoms related to the knee joint in osteoarthritis and after total knee replacement surgery. The scale consists of 42 items that evaluate symptoms, pain, daily life functions and activities, sports and recreational activities, and quality of life related to the knee. Responses are on a 5-point Likert scale ranging from 0 (no problems or difficulties) to 4 (severe problems or difficulties).
Measured: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Secondary outcomes (4)
Barthel Index (Activities of daily living)
The Barthel Index (BI) for Activities of Daily Living is an ordinal scale that measures a person's ability to perform daily activities through 10 items. Each item is rated by the evaluator based on the individual's capacity to complete the task independently, with assistance, or not at all, with scores as follows:0=unable, 1=needs assistance, 2=independent. The total scores are on a scale from 0 to 100. Interpretation of dependency levels: 0 to 20: Total dependence/21 to 60:Severe dependence/61 to 90:Moderate dependence/91 to 99:Slight dependence.
Measured: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Modified Rankin Scale (Degree of disability in daily activities)
The Modified Rankin Scale (mRS) measures the degree of disability, scored from 0 to 6: 0:No symptoms/1:No significant disability despite symptoms/2:Slight disability; unable to perform all previous activities but able to manage own affairs without assistance/3:Moderate disability; requires some help but can walk without assistance/4:Moderately severe disability/5:bedridden, incontinent, and requiring constant care and assistance/6: Dead
Measured: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Credibility/Expectancy Questionnaire (psychological and behavioral assessment)
The Credibility/Expectancy Questionnaire(CEQ)measures treatment expectancy and the credibility.It assesses two aspects:cognitive aspects as the reliability of the treatment and emotional aspects, as the belief in improvement related to the treatment.
Measured: At baseline (T0)
COPing Orientation to Problems Experienced-Italian Version (Assessment of coping styles)
The COPing Orientation to Problems Experienced-Italian Version(COP-NIV)explores five main independent dimensions. It consists of 60 items assessing how individuals react to stressful events, rated on a 4point scale
Measured: At baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthrosis of the KneeStudies 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
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Belinda Rizzo
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Responsible party
- Sponsor-investigator, Laura Belinda Rizzo, University of Bari Aldo Moro
- Investigators
- Marisa Megna, Professor, Study director, University Bari "A. Moro"Teresa Paolucci, Research, Study director, University of Chieti-Pescara "G. D'Annunzio"Laura B Rizzo, MD, Principal investigator, University of Bari "A. Moro"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032805
- Sponsor's protocol ID
- Prot.2114/CEL
- Acronym
- TKA
- Status last verified
- May 2026
- First submitted
- 5 May 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paolucci T, Rizzo LB, Cichelli A, Bressi F, Bernetti A, Fari G, Megna M, Bonerba M, Marotta A, Di Nicola M. Coping to move again: the psychological dimension of tele-supported rehabilitation after knee arthroplasty-A randomized controlled trial. Front Digit Health. 2026 Jul 23;8:1885446. doi: 10.3389/fdgth.2026.1885446. eCollection 2026.
PubMed 42564154
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping to Move Again: The Psychological Dimension of Tele-Supported Rehabilitation After Knee Arthroplasty - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07032805
- Acronym / sponsor ID
- TKA / Prot.2114/CEL
- Conditions
- Arthrosis of the Knee
- Keywords
- telemedicine, primary osteoarthritis, rehabilitation, discontinuation of walking aids, Reduction of pain, physical function, psycho-behavioral assessments, attitude toward technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Laura Belinda RizzoUniversity, hospital or other
- Collaborators
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 24 Jun 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 aim of this clinical study is to evaluate the effectiveness of a telemedicine approach in improving treatment adherence and functional outcomes in patients recently underwent total knee replacement for primary osteoarthritis. The study focuses on patients aged between 50 and 75 years, with a BMI below 35, and without known oncological or neurological conditions. Participants will receive a personalized rehabilitation program, including initial assessment, psychomotivational framing, and rehabilitation interventions based on telemedicine. The goal is to provide a framework for adopting more detailed and personalized rehabilitative strategies.The main research questions are:• Primary: pain reduction (VAS), physical function (WOMAC, KOOS).• Secondary: activities of daily living (Barthel index, mRS); psychobehavioral assessments (CEQ, PAM13, CG-PAM, COP-NIV); attitude towards technology (TAM); use of analgesics and walking aids.Sample size is estimated at 40 patients (20 per group), accounting for a 20% dropout rate, divided into:• Control group: standard outpatient rehabilitation with a personalized exercise program.• Study group: standard outpatient rehabilitation with a personalized exercise program plus telemonitoring via video calls. Procedures:• Recruitment and signing of informed consent; • Initial assessment (demographic data, baseline tests) and start of post-acute rehabilitation during hospitalization at T0;• Outpatient rehabilitation interventions with/without tele-rehabilitation support (twice weekly) at discharge, with follow-up assessments at T1 (1.5 months) and T2 (3 months);• Weekly recording of analgesic consumption through a dedicated diary;• Recording the date of discontinuation of walking aids.
Detailed description
To ensure quality and ethical standards in the design and implementation of our randomized clinical trial (RCT), we will apply the Helsinki criteria and the CONSORT checklist. All patients hospitalized for rehabilitation after total knee arthroplasty (TKA) at the San Giovanni di Dio Rehabilitation Center in Adelfia (BA) will be evaluated for eligibility to participate in a clinical study on primary symptomatic osteoarthritis (OA) of the knee between July and October 2025.Inclusion criteria (in addition to those already mentioned in the brief summary): •Ability to stand on one leg. Exclusion criteria: •Post-traumatic or inflammatory knee OA; •Valgus/varus deformity (hip-knee-ankle angle > or < 10°).The control group and the study group, after medical, physiotherapeutic, and psychological assessment, will receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be delivered in two physiotherapy sessions per day, each lasting 45 minutes, during the 22-25 days of hospitalization. Following discharge, participants will receive outpatient treatment consisting of two 45-minute sessions per week for three months at a physiotherapy clinic. The control group will follow this program as usual, while the study group will have the same program reinforced with home supervision via telemedicine. A physiotherapist, trained on the initial psychological assessments, will conduct teleconsultations using Zoom (with end-to-end encryption). Patient characteristics and outcome measures will be reported in aggregate form, as mean ± standard deviation for continuous variables and absolute frequencies (percentages) for categorical variables. Statistical analysis of outcomes will include testing the significance of differences. The two groups will be compared based on baseline characteristics and changes in outcomes. Data Profile: Since variables are non-normally distributed (Shapiro-Wilk test), the study uses non-parametric methods. Data is expressed as medians (IQR) or frequencies (%).
Baseline Comparisons: Groups are compared via the Mann-Whitney U test (continuous) and χ 2 or Fisher's exact tests (categorical). Longitudinal Analysis: Clinical outcomes over time (T0-T2) are evaluated using a non-parametric mixed-effects model to analyze time, group, and their interaction. Changes \& Correlations: Relative variation is calculated as Δ=(T 2-T0)/T0. Its relationship with baseline psychological scores is assessed via Spearman's correlation. Thresholds: Analyses are performed in R (v4.2), using a significance threshold of p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outpatient rehabilitative treatment plus tele-rehabilitation | Experimental | Procedure: personalized outpatient rehabilitation treatment after TKAThe study group will undergo medical, physiotherapeutic, and psychological assessment. They will then receive a treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and developing walking ability. This will be delivered in two daily physiotherapy sessions, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue outpatient treatment with two 45-minute sessions per week for three months at a physiotherapy clinic. Additionally, they will receive home supervision from a physiotherapist via telemedicine (video calls using Zoom with encryption), trained on the patient's initial issues identified through psychological evaluation. |
| Standard outpatient rehabilitative treatment | Active comparator | Procedure: standard outpatient rehabilitation treatment after TKAThe control group will undergo medical, physiotherapeutic, and psychological assessments. They will then receive treatment focused on strengthening lower limb muscles, improving joint range of motion, enhancing balance, and gait training. This will be administered in two physiotherapy sessions per day, each lasting 45 minutes, over the 22-25 days of hospitalization. After discharge, they will continue with outpatient physiotherapy consisting of two 45-minute sessions per week for three months at an outpatient physiotherapy clinic. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent unilateral total knee arthroplasty;
- Body Mass Index (BMI) < 35;
- Ability to stand on one leg;
- Absence of active known neurological or oncological diseases.
Key exclusion criteria (2 listed)
- Post-traumatic or inflammatory knee osteoarthritis (OA);
- Valgus/varus deformity (hip-knee-ankle angle > or < 10°).
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 |
|---|---|---|
| personalized outpatient rehabilitation treatment after TKApersonalized outpatients rehabilitation treatment after TKA, including psychomotivational framing, and telemedicine-based rehabilitation interventions | Procedure or surgery | outpatient rehabilitative treatment plus tele-rehabilitation |
| standard outpatient rehabilitation treatment after TKAstandard outpatient rehabilitation treatment after TKA | Procedure or surgery | Standard outpatient rehabilitative treatment |
Primary outcome
VAS (Pain assessment)
Time frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
We will use the VAS (Visual Analogue Scale) to quickly and reliably determine the pain perceived by the patient. The VAS (Visual Analogue Scale) consists of a horizontal line 10 centimeters long, with two endpoints representing opposite levels of sensation. Zero is at the extreme left, indicating "No pain," and ten is at the extreme right, representing "The worst pain imaginable." The patient subjectively expresses their perception of pain by indicating a point on the line.
Western Ontario and McMaster Universities Arthritis Index (Physical function)
Time frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a patient-reported outcome questionnaire that assesses symptoms and activity limitations in osteoarthritis or following joint replacement surgery. It evaluates the severity of pain, joint stiffness, and physical function with 24 questions, each using a Likert scale ranging from 0 (no symptoms) to 4 (high intensity or difficulty);
Knee Injury and Osteoarthritis Outcome Score (Knee function)
Time frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire that assesses symptoms related to the knee joint in osteoarthritis and after total knee replacement surgery. The scale consists of 42 items that evaluate symptoms, pain, daily life functions and activities, sports and recreational activities, and quality of life related to the knee. Responses are on a 5-point Likert scale ranging from 0 (no problems or difficulties) to 4 (severe problems or difficulties).
4 secondary outcomes
Barthel Index (Activities of daily living)
Time frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Modified Rankin Scale (Degree of disability in daily activities)
Time frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)
Credibility/Expectancy Questionnaire (psychological and behavioral assessment)
Time frame: At baseline (T0)
COPing Orientation to Problems Experienced-Italian Version (Assessment of coping styles)
Time frame: At baseline (T0)
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 11 May 2026.
- Derived from this study: PubMed 42564154Paolucci T, Rizzo LB, Cichelli A, Bressi F, Bernetti A, Fari G, Megna M, Bonerba M, Marotta A, Di Nicola M. Coping to move again: the psychological dimension of tele-supported rehabilitation after knee arthroplasty-A randomized controlled trial. Front Digit Health. 2026 Jul 23;8:1885446. doi: 10.3389/fdgth.2026.1885446. eCollection 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. This study is not recruiting at the moment.
Marisa Megna, Professor study director
University Bari "A. Moro"
Teresa Paolucci, Research study director
University of Chieti-Pescara "G. D'Annunzio"
Laura B Rizzo, MD principal investigator
University of Bari "A. Moro"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized outpatient rehabilitation treatment after TKA and standard outpatient rehabilitation treatment after TKA in people with Arthrosis of the Knee, run by Laura Belinda Rizzo at 1 site in Italy.
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 2 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 11 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 Italy. 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?
VAS (Pain assessment) (time frame: At baseline (T0), at 1.5 months (T1), and at 3 months (T2)). The study lists 3 primary outcomes in all. 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 NCT07032805, which also lists 1 linked publication.
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 11 May 2026.