§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis

Phase 3

Completed

• Conditions: HIP AND KNEE OSTEOARTHRITIS; Geriatric Assessment; Geriatric Depression
• Interventions: Drug: Periarticular Procaine Injection (PAPI); Other: Kinesiotherapy

• Registration Number: NCT06717724
• Lead Sponsor: Sf Luca Chronic Disease Hospital

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.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-08
• Primary Completion: 2024-06-08
• Study Completion: 2024-10-30
• Study First Submitted: 2024-11-30
• Study First Submitted QC: 2024-11-30
• Last Update Submitted: 2024-11-30
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Periarticular Procaine Injection (PAPI)	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)
Experimental	Kinesiotherapy	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)
Control	Kinesiotherapy	Participants received only physical therapy without procaine injections.

Primary Outcome Measures

Name	Time	Method
Pain Levels	Baseline to Day 10	Change in Pain Level on Visual Analogue Scale (VAS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

"Sf. Luca" Chronic Disease Hospital; 🇷🇴 Bucharest, Romania