PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.

Detailed Description
-----------------
The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders of different aetiology and localisation, displaying a variety of symptoms. Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management in relation to the Summary of Product Characteristics (SmPC).

Official Title
-----------------
PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: A Non-interventional Observational Study.

Conditions
-----------------
Rheumatic Diseases, Arthralgia, Myalgias/Myopathy, Lumbago

Participation Criteria
=================
Eligibility Criteria
-----------------
Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under Cohort / Group. Observational Criteria (=inclusion criteria for documentation): Males and females At least 18 years old Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc. Exclusion criteria for documentation: younger than 18 years no Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc. no treatment with PASCOE-Agil HOM-Injektopas

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br>Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Tolerability of the Drug | Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3). It was measured by a score: very well tolerated (no side effects) moderately tolerated (mild side effects) poorly tolerated (marked side effects) | after end of study | 
| Pain at Rest | Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Pain in Movement | Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Pain After Rest | Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Pain on Weight-bearing | Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Morning Stiffness | Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Tenderness | Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 
| Antalgic Position | Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period. | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of the Drug | Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance. | from enrollment until completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatism, arthralgia, myalgia, lumbago, homoeopathy, injection, PASCOE-Agil HOM Injektopas, efficacy, tolerability, acceptance, safety