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§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis

Complementary Treatment With Procaine Periarticular Injections for Pain Reduction and Functional Improvement in Elderly Individuals With Osteoarthritis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06717724
Enrollment
203
Registered
2024-12-05
Start date
2024-02-08
Completion date
2024-10-30
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIP AND KNEE OSTEOARTHRITIS, Geriatric Assessment, Geriatric Depression

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)

Brief 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. 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.

Interventions

DRUGPeriarticular 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

Kinesiotherapy

Sponsors

Sf Luca Chronic Disease Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Individuals with Alzheimer's, severe depression, cancer, or other severe health conditions, and those with allergies to procaine

Design outcomes

Primary

MeasureTime frameDescription
Pain LevelsBaseline to Day 10Change in Pain Level on Visual Analogue Scale (VAS)

Secondary

MeasureTime frameDescription
Functional ImprovementBaseline to Day 10Change in Lequesne Index Score
ADL and IADL ScoresBaseline to Day 10Changes in Activities of Daily Living and Instrumental ADL scores
Geriatric Depression ScaleBaseline to Day 10Change in Depression Symptoms

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026