Clinical trial NCT06717724: § Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis
Official title: Complementary Treatment With Procaine Periarticular Injections for Pain Reduction and Functional Improvement in Elderly Individuals With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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)
Lead sponsor: Sf Luca Chronic Disease Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 203
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Levels
timeFrame: Baseline to Day 10
Secondary outcomes:
measure: Functional Improvement
timeFrame: Baseline to Day 10
measure: ADL and IADL Scores
timeFrame: Baseline to Day 10
measure: Geriatric Depression Scale
timeFrame: Baseline to Day 10
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Sf. Luca" Chronic Disease Hospital
Study officials:
affiliation: "Carol Davila" University of Medicine and Pharmacy Geriatrics and Gerontology Clinic, "Sf. Luca" Chronic Disease Hospital Bucharest
name: Sorina Maria Aurelian
role: PRINCIPAL_INVESTIGATOR
References: