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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Control | Active Comparator | Participants received only physical therapy without procaine injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels | Change in Pain Level on Visual Analogue Scale (VAS) | Baseline to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Improvement | Change in Lequesne Index Score | Baseline to Day 10 |
| ADL and IADL Scores | Changes in Activities of Daily Living and Instrumental ADL scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sorina Maria Aurelian | "Carol Davila" University of Medicine and Pharmacy Geriatrics and Gerontology Clinic, "Sf. Luca" Chronic Disease Hospital Bucharest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Sf. Luca" Chronic Disease Hospital | Bucharest | Romania |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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
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| Kinesiotherapy | Other | Kinesiotherapy |
|
| Baseline to Day 10 |
| Geriatric Depression Scale | Change in Depression Symptoms | Baseline to Day 10 |
| D012216 |
| Rheumatic Diseases |