§ 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

§ 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

Study Overview

• Status: Completed
• Conditions: Geriatric Assessment; Geriatric Depression; HIP AND KNEE OSTEOARTHRITIS
• Intervention / Treatment: Drug: Periarticular Procaine Injection (PAPI); Other: Kinesiotherapy

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 Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • "Sf. Luca" Chronic Disease Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: 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; Other: Kinesiotherapy; Kinesiotherapy
Active Comparator: Control; Participants received only physical therapy without procaine injections.	Other: Kinesiotherapy; Kinesiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Levels	Change in Pain Level on Visual Analogue Scale (VAS)	Baseline to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Improvement	Change in Lequesne Index Score	Baseline to Day 10
ADL and IADL Scores	Changes in Activities of Daily Living and Instrumental ADL scores	Baseline to Day 10
Geriatric Depression Scale	Change in Depression Symptoms	Baseline to Day 10

Collaborators and Investigators

• Sponsor: Sf Luca Chronic Disease Hospital
• Investigators: Principal Investigator: Sorina Maria Aurelian, "Carol Davila" University of Medicine and Pharmacy Geriatrics and Gerontology Clinic, "Sf. Luca" Chronic Disease Hospital Bucharest

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): June 8, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: knee osteoarthritis; physical therapy; infiltration; geriatric depression; geriatric assessment; hip osteoarthritis; instrumental activities of daily living (IADL); periarticular injections; activities of daily living (ADL); procaine; gerovital h3; ana aslan
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Behavioral Symptoms; Osteoarthritis; Osteoarthritis, Knee; Depression; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Procaine
• Other Study ID Numbers: SfLucaCDHProcaine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No