HIP AND KNEE OSTEOARTHRITISPhase 3NCT06717724
§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis
A Phase 3 study testing Periarticular Procaine Injection (PAPI) and Kinesiotherapy in people with HIP AND KNEE OSTEOARTHRITIS and Geriatric Assessment, run by Sf Luca Chronic Disease Hospital at 1 site in Romania.
Trial summary
§ The goal of this clinical trial is to assess the effect of periarticular procaine injections combined with physical therapy on joint pain in individuals 65 and older suffering from osteoarthritis of the hip or the knee. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HIP AND KNEE OSTEOARTHRITIS, Geriatric Assessment, Geriatric Depression
- What is being tested?
- Periarticular Procaine Injection (PAPI) and Kinesiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteRomania
- Study dates
- 8 Feb 2024to 30 Oct 2024
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults aged 65 and older diagnosed with knee or hip osteoarthritis per the American College of Rheumatology criteria. Must exhibit radiographic evidence of OA and experience persistent joint pain
Who cannot join
- Individuals with Alzheimer's, severe depression, cancer, or other severe health conditions, and those with allergies to procaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complementary Treatment With Procaine Periarticular Injections for Pain Reduction and Functional Improvement in Elderly Individuals With Osteoarthritis
§ The goal of this clinical trial is to assess the effect of periarticular procaine injections combined with physical therapy on joint pain in individuals 65 and older suffering from osteoarthritis of the hip or the knee. The main question it aims to answer is: Is procaine effective in decreasing joint pain?
Researchers will compare procaine injections combined with physical therapy to physical therapy only to evaluate whether or not procaine helps decrease joint pain.
Participants will:
Undergo procaine periarticular injections and physical therapy Assess their symptoms and pain using scales and tests provided
Read the detailed description
This clinical trial aims to evaluate the safety and efficacy of procaine complex injections in managing pain and improving functional capacity in elderly patients with osteoarthritis in the knee and/or hip. The study enrolled 178 patients aged 65 and older, who were randomly assigned to receive either physical therapy combined with periarticular procaine injections or physical therapy alone. Pain levels were assessed using the Visual Analogue Scale (VAS), and functional capacity was evaluated using the Lequesne Index, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), and other geriatric assessment tools. Results indicated significant pain reduction and functional improvement in the procaine group, highlighting a safe alternative treatment to surgery for older adults with osteoarthritis.
- Being tested
- Periarticular Procaine Injection (PAPI), Kinesiotherapy
- Keywords
- procaine, infiltration, geriatric assessment, periarticular injections, gerovital h3, geriatric depression, hip osteoarthritis, knee osteoarthritis, ana aslan, physical therapy, activities of daily living (ADL), instrumental activities of daily living (IADL)
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular Procaine Injection (PAPI)Drug
Participants will receive periarticular 5 ml procaine injections targeting painful joints for 10 consecutive days alternating between knee- and/or hip joints
KinesiotherapyOther
Kinesiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants in the experimental arm received daily periarticular injections of procaine complex solution (5 ml containing 100 mg procaine hydrochloride) over a 10-day period. All injections were administered using sterile technique. Prior to treatment, sensitivity to procaine hydrochloride was assessed with a subcutaneous test dose (0.5 ml) Receives: Drug: Periarticular Procaine Injection (PAPI); Other: Kinesiotherapy |
| Control | Active comparator | Participants received only physical therapy without procaine injections. Receives: Other: Kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels
Change in Pain Level on Visual Analogue Scale (VAS)
Measured: Baseline to Day 10
Secondary outcomes (3)
Functional Improvement
Change in Lequesne Index Score
Measured: Baseline to Day 10
ADL and IADL Scores
Changes in Activities of Daily Living and Instrumental ADL scores
Measured: Baseline to Day 10
Geriatric Depression Scale
Change in Depression Symptoms
Measured: Baseline to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start8 Feb 2024
- Primary completion8 Jun 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIP AND KNEE OSTEOARTHRITISStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are divided into an experimental group that receives the basic treatment combined with the intervention and one control group that receives the basic treatment
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sf Luca Chronic Disease Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sorina Maria Aurelian, Principal investigator, "Carol Davila" University of Medicine and Pharmacy Geriatrics and Gerontology Clinic, "Sf. Luca" Chronic Disease Hospital Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717724
- Sponsor's protocol ID
- SfLucaCDHProcaine
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Treatment With Procaine Periarticular Injections for Pain Reduction and Functional Improvement in Elderly Individuals With Osteoarthritis
- ClinicalTrials.gov ID
- NCT06717724
- Acronym / sponsor ID
- SfLucaCDHProcaine
- Keywords
- procaine, infiltration, geriatric assessment, periarticular injections, gerovital h3, geriatric depression, hip osteoarthritis, knee osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Sf Luca Chronic Disease HospitalUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Dec 2024 (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 goal of this clinical trial is to assess the effect of periarticular procaine injections combined with physical therapy on joint pain in individuals 65 and older suffering from osteoarthritis of the hip or the knee. The main question it aims to answer is: Is procaine effective in decreasing joint pain?
Researchers will compare procaine injections combined with physical therapy to physical therapy only to evaluate whether or not procaine helps decrease joint pain.
Participants will:
Undergo procaine periarticular injections and physical therapy Assess their symptoms and pain using scales and tests provided
Detailed description
This clinical trial aims to evaluate the safety and efficacy of procaine complex injections in managing pain and improving functional capacity in elderly patients with osteoarthritis in the knee and/or hip. The study enrolled 178 patients aged 65 and older, who were randomly assigned to receive either physical therapy combined with periarticular procaine injections or physical therapy alone. Pain levels were assessed using the Visual Analogue Scale (VAS), and functional capacity was evaluated using the Lequesne Index, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), and other geriatric assessment tools. Results indicated significant pain reduction and functional improvement in the procaine group, highlighting a safe alternative treatment to surgery for older adults with osteoarthritis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are divided into an experimental group that receives the basic treatment combined with the intervention and one control group that receives the basic treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Periarticular Procaine Injection (PAPI), Other: KinesiotherapyParticipants in the experimental arm received daily periarticular injections of procaine complex solution (5 ml containing 100 mg procaine hydrochloride) over a 10-day period. All injections were administered using sterile technique. Prior to treatment, sensitivity to procaine hydrochloride was assessed with a subcutaneous test dose (0.5 ml) |
| Control | Active comparator | Other: KinesiotherapyParticipants received only physical therapy without procaine injections. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adults aged 65 and older diagnosed with knee or hip osteoarthritis per the American College of Rheumatology criteria. Must exhibit radiographic evidence of OA and experience persistent joint pain
Key exclusion criteria (1 listed)
- Individuals with Alzheimer's, severe depression, cancer, or other severe health conditions, and those with allergies to procaine
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 |
|---|---|---|
| Periarticular Procaine Injection (PAPI)Participants will receive periarticular 5 ml procaine injections targeting painful joints for 10 consecutive days alternating between knee- and/or hip joints | Drug | Experimental |
| KinesiotherapyKinesiotherapy | Other | Control, Experimental |
Primary outcome
Pain Levels
Time frame: Baseline to Day 10
Change in Pain Level on Visual Analogue Scale (VAS)
3 secondary outcomes
Functional Improvement
Time frame: Baseline to Day 10
ADL and IADL Scores
Time frame: Baseline to Day 10
Geriatric Depression Scale
Time frame: Baseline to Day 10
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 5 Dec 2024.
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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.
Sorina Maria Aurelian principal investigator
"Carol Davila" University of Medicine and Pharmacy Geriatrics and Gerontology Clinic, "Sf. Luca" Chronic Disease Hospital Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Periarticular Procaine Injection (PAPI) and Kinesiotherapy in people with HIP AND KNEE OSTEOARTHRITIS and Geriatric Assessment, run by Sf Luca Chronic Disease Hospital at 1 site in Romania.
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 1 inclusion and 1 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 5 Dec 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 Romania. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Levels (time frame: Baseline to Day 10). 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 5 Dec 2024.