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Completed

NCT Number: NCT06717724

§ Procaine Periarticular Injections for Pain Reduction in Elderly 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

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Key information

Conditions

HIP AND KNEE OSTEOARTHRITIS Arthritis Geriatric Assessment Geriatric Depression Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"Sf. Luca" Chronic Disease Hospital

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Kinesiotherapy

Other

Kinesiotherapy

Primary outcomes

  1. Pain Levels

    Time frame: Baseline to Day 10

    Change in Pain Level on Visual Analogue Scale (VAS)

Secondary outcomes

  1. Functional Improvement

    Time frame: Baseline to Day 10

    Change in Lequesne Index Score

  2. ADL and IADL Scores

    Time frame: Baseline to Day 10

    Changes in Activities of Daily Living and Instrumental ADL scores

  3. Geriatric Depression Scale

    Time frame: Baseline to Day 10

    Change in Depression Symptoms

Sponsors and collaborators

Lead sponsor

Sf Luca Chronic Disease Hospital

Other

Registry information

Official study title

Complementary Treatment With Procaine Periarticular Injections for Pain Reduction and Functional Improvement in Elderly Individuals With Osteoarthritis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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