Osteo Arthritis KneePhase 4NCT05460871
Pregabalin for Central Sensitization in TKA
A Phase 4 study testing Pregabalin 75mg in people with Osteo Arthritis Knee and Central Nervous System Sensitization, run by University of Iowa at 1 site in United States.
Trial summary
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Participants will be identified who are indicated for TKA. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Central Nervous System Sensitization
- What is being tested?
- Pregabalin 75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 25 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing native joint unilateral TKA due to Grade 3-4 primary osteoarthritis
- Patients with score of at least 40 on Central Sensitization Inventory
- Patients who will complete PT within the U of Iowa Health Care system
- Patients who have been nonsmokers for > 2 years
- Patients between the ages of 50 and 85
Who cannot join
- Patients already taking pregabalin or had an adverse effect with pregabalin in the past
- Patients indicated for joint revision surgery
- Patients taking at least 30 morphine milligram equivalents per day for the past 1 month
- Patients with an estimate GFR < 30 ml/min
- Patients who do not have an understanding of English
- Patients who are pregnant or women of child-bearing years
Show all 9Show fewer
- Patients who are prisoners
- Patients who score < 40 on the CSI
- Patients who answer Yes to any questions on the Columbia Suicide Severity Rating Scale or express suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
Official title: Evaluating the Efficacy and Safety of Pregabalin in Total Knee Arthroplasty Patients With Central Sensitization
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS).
Participants will be identified who are indicated for TKA. Interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet inclusion criteria and agree to participate, they will complete the informed consent before being randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. They will also be scheduled to have a pre-operative physical therapy (PT) appointment which will include tests and measures standard to PT. Tests will include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures.
Read more
On the day of surgery participants will be asked about any adverse effects of study medication and determine need to withdraw from study. The post-operative plan will be reviewed, including dose of study medication. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA . All participants will complete standard of practice physical therapy.
After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. The study pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average).
At the 6 week post-operative visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine MME based on patient report of quantity of opioid medication used. A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.
Read the detailed description
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Central sensitization occurs when the brain (central nervous system) becomes hypersensitized and hypervigilant, over-reacting to any painful (and sometimes nonpainful) stimuli. Patients with greater central sensitization have been shown to have significantly more pain after surgery, including TKA. We are proposing to explore whether treatment with a nerve pain medication, pregabalin, can improve post-operative pain and function in these patients. This medication has been shown to improve central sensitization pain in the chronic pain setting but has not been studied for this purpose in the acute surgical pain setting.
Participants will be identified at the visit in which they are indicated for TKA. Patients indicated for a TKA will be approached about participating in the study. Either at that visit or later by phone or e-mail, interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), which is part of the standard orthopedic evaluation. They will also be asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet study inclusion criteria, and they agree to participate, they will complete the informed consent (in person or on-line) and then be randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. The participant will receive usual medication counseling for this medication. They will also be scheduled to have a pre-operative physical therapy (PT) appointment at the time of their pre-op visit, which will include tests and measures standard to PT, but must include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures.
On the day of surgery participants will be asked about any adverse effects of study medication, and determine need to withdraw from study (for any reason). The post-operative plan will also be reviewed, including dose of study medication, for the pregabalin group. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA (a nerve block and/or spinal unless contraindicated, anti-inflammatory drugs (NSAID) and acetaminophen (unless contraindicated) as well as oral opioid (usually oxycodone or hydromorphone) to use as needed for severe pain. All participants will complete standard of practice physical therapy on day of surgery or until discharged to home.
After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. At this time, the pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average).
Standard follow-up after TKA is 6 weeks. At this visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine, based on patient report, of quantity of opioid medication used (MME). A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.
- Being tested
- Pregabalin 75mg
- Keywords
- Arthroplasty, Pain, Central Nervous System Sensitization, Osteo Arthritis Knee, Pregabalin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
Also called Study
participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, then 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days, then stop.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive standard peri-operative pain management |
| Study (Pregabalin) | Experimental | Participants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop. Receives: Drug: Pregabalin 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the Change Using the Knee Osteoarthritis Outcome Survey- Activities of Daily Living Subscale
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Activities of Daily Living subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
Measured: Approximately 6 weeks
Secondary outcomes (9)
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Symptoms
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Symptoms subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5=always.
Measured: Approximately 6 weeks
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Stiffness
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Stiffness subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
Measured: Approximately 6 weeks
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Sports and Recreational Activities
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Sports and Recreational Activities subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
Measured: Approximately 6 weeks
Calculate the Change in Central Sensitization Inventory Score
The difference in change on the Central Sensitization Inventory assessment will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks follow-up. The survey is scored on a continuous scale as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Measured: Approximately 6 weeks
Calculate the Change of Physical Function Using the Timed Up & Go Assessment
The change of physical function using the Timed Up \& Go Assessment (TUG) will be evaluated at four intervals during the study; baseline, during the immediate post-operative time period (day of surgery or post-operative day 1), 7-day follow-up, and at 6-week follow-up. Patients will stand up from a chair, walk approximately 10 feet, turn, walk back and sit back down. This activity will be timed in seconds. The change from baseline until 6-week follow-up will be reported.
Measured: Approximately 6 weeks
Calculate the Change of Physical Function Using the Stand to Sit Assessment
The change of physical function using the Stand to Sit Assessment (STS) will be evaluated at four intervals during the study; baseline, during the immediate post-operative time period (day of surgery or post-operative day 1), 7-day follow-up, and at 6-week follow-up. Patients will stand up and sit down from a chair 5 times in a row, as quickly as they can. This activity will be timed in seconds. The change from baseline until 6-week follow-up will be reported.
Measured: Approximately 6 weeks
Calculate the Change of Physical Function Using the Patient-Specific Functional Scale Assessment
The change of physical function using the Patient-Specific Functional Scale Assessment (PSFS) will be evaluated at four intervals during the study; baseline, during the immediate post-operative time period (day of surgery or post-operative day 1), 7-day follow-up, and at 6-week follow-up. At baseline, patients will asked to identify activities they are having difficulty/unable to do and would like to gain the mobility back after procedure. The activities will be scored on a continuous rating with The change from baseline until 6-week follow-up will be reported.
Measured: Approximately 6 weeks
Measure the Amount of Pain Reported After Procedure
Using a numerical rating scale (0-10), patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. The pain scores will be collected on 7-day post procedure follow-up and at the 6-week follow up. The change between the timepoints will be reported.
Measured: Approximately 6 weeks
Measure Post-operative Opioid Usage
Review with subjects the type and amount of additional pain (opioid) medication required to control their pain. This will be examined approximately 7-day post procedure and at the 6-week post procedure follow-up. The amount of opioid medication taken by the subject will be converted to morphine equivalents for reporting purposes.
Measured: Approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start21 Feb 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Why it stopped: Enrollment lower than anticipated; none of the subjects completing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteo Arthritis 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label interventional trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee A. Kral, University of Iowa
- Investigators
- Lee Kral, Pharm. D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460871
- Sponsor's protocol ID
- 202105361
- Status last verified
- Feb 2025
- First submitted
- 13 Jul 2022
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Pregabalin in Total Knee Arthroplasty Patients With Central Sensitization
- ClinicalTrials.gov ID
- NCT05460871
- Acronym / sponsor ID
- 202105361
- Keywords
- Arthroplasty, Pain, Central Nervous System Sensitization, Osteo Arthritis Knee, Pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment lower than anticipated; none of the subjects completing the study.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS).
Participants will be identified who are indicated for TKA. Interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet inclusion criteria and agree to participate, they will complete the informed consent before being randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. They will also be scheduled to have a pre-operative physical therapy (PT) appointment which will include tests and measures standard to PT. Tests will include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures.
On the day of surgery participants will be asked about any adverse effects of study medication and determine need to withdraw from study. The post-operative plan will be reviewed, including dose of study medication. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA . All participants will complete standard of practice physical therapy.
After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. The study pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average).
At the 6 week post-operative visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine MME based on patient report of quantity of opioid medication used. A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.
Detailed description
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Central sensitization occurs when the brain (central nervous system) becomes hypersensitized and hypervigilant, over-reacting to any painful (and sometimes nonpainful) stimuli. Patients with greater central sensitization have been shown to have significantly more pain after surgery, including TKA. We are proposing to explore whether treatment with a nerve pain medication, pregabalin, can improve post-operative pain and function in these patients. This medication has been shown to improve central sensitization pain in the chronic pain setting but has not been studied for this purpose in the acute surgical pain setting.
Participants will be identified at the visit in which they are indicated for TKA. Patients indicated for a TKA will be approached about participating in the study. Either at that visit or later by phone or e-mail, interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), which is part of the standard orthopedic evaluation. They will also be asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet study inclusion criteria, and they agree to participate, they will complete the informed consent (in person or on-line) and then be randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. The participant will receive usual medication counseling for this medication. They will also be scheduled to have a pre-operative physical therapy (PT) appointment at the time of their pre-op visit, which will include tests and measures standard to PT, but must include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures.
On the day of surgery participants will be asked about any adverse effects of study medication, and determine need to withdraw from study (for any reason). The post-operative plan will also be reviewed, including dose of study medication, for the pregabalin group. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA (a nerve block and/or spinal unless contraindicated, anti-inflammatory drugs (NSAID) and acetaminophen (unless contraindicated) as well as oral opioid (usually oxycodone or hydromorphone) to use as needed for severe pain. All participants will complete standard of practice physical therapy on day of surgery or until discharged to home.
After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. At this time, the pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average).
Standard follow-up after TKA is 6 weeks. At this visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine, based on patient report, of quantity of opioid medication used (MME). A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label interventional trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive standard peri-operative pain management |
| Study (Pregabalin) | Experimental | Drug: Pregabalin 75mgParticipants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days. Then Stop. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing native joint unilateral TKA due to Grade 3-4 primary osteoarthritis
- Patients with score of at least 40 on Central Sensitization Inventory
- Patients who will complete PT within the U of Iowa Health Care system
- Patients who have been nonsmokers for > 2 years
- Patients between the ages of 50 and 85
Key exclusion criteria (9 listed)
- Patients already taking pregabalin or had an adverse effect with pregabalin in the past
- Patients indicated for joint revision surgery
- Patients taking at least 30 morphine milligram equivalents per day for the past 1 month
- Patients with an estimate GFR < 30 ml/min
- Patients who do not have an understanding of English
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 |
|---|---|---|
| Pregabalin 75mgAlso: Studyparticipants will receive pregabalin orally 75mg twice daily x 7 days prior to surgery, then 150mg twice daily x 7 days after surgery, followed by 75mg twice daily x 7 days, then stop. | Drug | Study (Pregabalin) |
Primary outcome
Calculate the Change Using the Knee Osteoarthritis Outcome Survey- Activities of Daily Living Subscale
Time frame: Approximately 6 weeks
The difference in change on the Knee Osteoarthritis Outcome Survey (KOOS) - Activities of Daily Living subscale will be calculated between the treatment groups. The survey will be administered at baseline and at the subject's 6-weeks post procedure follow-up. The survey is scored on a continuous scale as follows: 1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme.
9 secondary outcomes
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Symptoms
Time frame: Approximately 6 weeks
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Stiffness
Time frame: Approximately 6 weeks
Calculate the Change Using the Knee Osteoarthritis Outcome Survey-Sports and Recreational Activities
Time frame: Approximately 6 weeks
Calculate the Change in Central Sensitization Inventory Score
Time frame: Approximately 6 weeks
Calculate the Change of Physical Function Using the Timed Up & Go Assessment
Time frame: Approximately 6 weeks
Calculate the Change of Physical Function Using the Stand to Sit Assessment
Time frame: Approximately 6 weeks
Calculate the Change of Physical Function Using the Patient-Specific Functional Scale Assessment
Time frame: Approximately 6 weeks
Measure the Amount of Pain Reported After Procedure
Time frame: Approximately 6 weeks
Measure Post-operative Opioid Usage
Time frame: Approximately 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lee Kral, Pharm. D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 75mg in people with Osteo Arthritis Knee and Central Nervous System Sensitization, run by University of Iowa at 1 site in United States.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 4 Mar 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calculate the Change Using the Knee Osteoarthritis Outcome Survey- Activities of Daily Living Subscale (time frame: Approximately 6 weeks). 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 4 Mar 2025.