§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis

NCT06717724 | Completed Phase 3

• 1 other identifier: SfLucaCDHProcaine
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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

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)

Outcome Measures

Primary Outcomes (1)

• Pain Levels

  Change in Pain Level on Visual Analogue Scale (VAS)

  Baseline to Day 10

Secondary Outcomes (3)

• Functional Improvement

  Baseline to Day 10

• ADL and IADL Scores

  Baseline to Day 10

• Geriatric Depression Scale

  Baseline to Day 10

Study Arms (2)

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); Other: Kinesiotherapy

Control

ACTIVE COMPARATOR

Participants received only physical therapy without procaine injections.

Other: Kinesiotherapy

Interventions

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

Experimental

Kinesiotherapy OTHER

Kinesiotherapy

Control; Experimental

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sf Luca Chronic Disease Hospital: lead

Study Sites (1)

"Sf. Luca" Chronic Disease Hospital

Bucharest, Romania

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sorina Maria Aurelian

  "Carol Davila" University of Medicine and Pharmacy Geriatrics and Gerontology Clinic, "Sf. Luca" Chronic Disease Hospital Bucharest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: February 8, 2024
• Primary Completion: June 8, 2024
• Study Completion: October 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-02

Locations

RO (1)