§ Procaine Periarticular Injections for Pain Reduction in Elderly With Osteoarthritis

Sf Luca Chronic Disease Hospital

Status and phase: Completed; Phase 3

Conditions: Geriatric Assessment; Geriatric Depression; HIP AND KNEE OSTEOARTHRITIS

Treatments: Drug: Periarticular Procaine Injection (PAPI); Other: Kinesiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06717724

SfLucaCDHProcaine

Details and patient eligibility

About

§ 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

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

Experimental

Experimental group

Description:

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)

Treatment:

Other: Kinesiotherapy

Drug: Periarticular Procaine Injection (PAPI)

Control

Active Comparator group

Description:

Participants received only physical therapy without procaine injections.

Treatment:

Other: Kinesiotherapy