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§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis

NCT ID: NCT06717724

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-10-30

Brief Summary

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§ 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

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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.

Conditions

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HIP AND KNEE OSTEOARTHRITIS Geriatric Assessment Geriatric Depression

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Periarticular Procaine Injection (PAPI)

Intervention Type DRUG

Participants will receive periarticular 5 ml procaine injections targeting painful joints for 10 consecutive days alternating between knee- and/or hip joints

Kinesiotherapy

Intervention Type OTHER

Kinesiotherapy

Control

Participants received only physical therapy without procaine injections.

Group Type ACTIVE_COMPARATOR

Kinesiotherapy

Intervention Type OTHER

Kinesiotherapy

Interventions

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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

Intervention Type DRUG

Kinesiotherapy

Kinesiotherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sf Luca Chronic Disease Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sorina Maria Aurelian

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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"Sf. Luca" Chronic Disease Hospital

Bucharest, , Romania

Site Status

Countries

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Romania

Other Identifiers

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SfLucaCDHProcaine

Identifier Type: -

Identifier Source: org_study_id