Arthralgia, Lumbago, Myalgias/Myopathy, Rheumatic Diseases
Conditions
Keywords
rheumatism, arthralgia, myalgia, lumbago, homoeopathy, injection, PASCOE-Agil HOM Injektopas, efficacy, tolerability, acceptance, safety
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).
Interventions
None listed
Sponsors
Pascoe Pharmazeutische Praeparate GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antalgic Position | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Visual Analog Scale (VAS) | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Tolerability of the Drug | after end of study | 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) |
| Pain at Rest | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Pain in Movement | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Pain on Weight-bearing | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Pain After Rest | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Morning Stiffness | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
| Tenderness | Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of the Drug | from enrollment until completion | 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. |
Participant flow
Recruitment details
The observational study was carried out by medically-trained doctors who generally treated patients with rheumatic disorders. By choosing a range of different medical specialties - predominantly orthopaedics, rheumatology, general medicine, sports medicine and family doctors - it was ensured that a broad spectrum of patients was recruited.
Pre-assignment details
The observational study was carried out between January 2008 and the end of May 2008 by 280 therapists. The non-interventional character of an observational study meant that no exact timeframe for the treatment of patients was specified.
Participants by arm
| Arm | Count |
|---|---|
| Observational Group Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses. | 1,374 |
| Total | 1,374 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | no medication use or questionable use | 13 |
| Overall Study | retrospective/extremely implausible data | 2 |
Baseline characteristics
| Characteristic | Observational Group |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 580 Participants |
| Age, Categorical Between 18 and 65 years | 791 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment Germany | 1374 participants |
| Sex/Gender, Customized female | 926 participants |
| Sex/Gender, Customized male | 437 participants |
| Sex/Gender, Customized unknown | 11 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 1,376 |
| serious Total, serious adverse events | 0 / 1,376 |
Outcome results
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Antalgic Position | 61.3 percentage of participants |
| Observational Group (Visit 2) | Antalgic Position | 79.4 percentage of participants |
| Observational Group (Visit 3) | Antalgic Position | 43.4 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Morning Stiffness | 54.4 percentage of participants |
| Observational Group (Visit 2) | Morning Stiffness | 74.5 percentage of participants |
| Observational Group (Visit 3) | Morning Stiffness | 42.9 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Pain After Rest | 60.2 percentage of participants |
| Observational Group (Visit 2) | Pain After Rest | 78.6 percentage of participants |
| Observational Group (Visit 3) | Pain After Rest | 49.8 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Pain at Rest | 57.5 percentage of participants |
| Observational Group (Visit 2) | Pain at Rest | 76.8 percentage of participants |
| Observational Group (Visit 3) | Pain at Rest | 44.1 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Pain in Movement | 67.5 percentage of participants |
| Observational Group (Visit 2) | Pain in Movement | 80.8 percentage of participants |
| Observational Group (Visit 3) | Pain in Movement | 50.1 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Pain on Weight-bearing | 64.1 percentage of participants |
| Observational Group (Visit 2) | Pain on Weight-bearing | 79.1 percentage of participants |
| Observational Group (Visit 3) | Pain on Weight-bearing | 50.4 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: descriptive, all patients who had an value
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Observational (Visit 1) | Tenderness | 64.5 percentage of participants |
| Observational Group (Visit 2) | Tenderness | 80.8 percentage of participants |
| Observational Group (Visit 3) | Tenderness | 50.3 percentage of participants |
Primary
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)
Time frame: after end of study
Population: 1374 were full analysed, data of 2 patient were additionally analysed for tolerability
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational (Visit 1) | Tolerability of the Drug | moderately/poorly tolerated | 2.8 percentage of participants |
| Observational (Visit 1) | Tolerability of the Drug | well tolerability | 97.2 percentage of participants |
Primary
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.
Time frame: Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)
Population: due to character of an observational study: all patient who had a value, descriptive
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Observational (Visit 1) | Visual Analog Scale (VAS) | 6.57 units on a scale | Standard Deviation 1.75 |
| Observational Group (Visit 2) | Visual Analog Scale (VAS) | 4.23 units on a scale | Standard Deviation 2.03 |
| Observational Group (Visit 3) | Visual Analog Scale (VAS) | 2.61 units on a scale | Standard Deviation 2.03 |
Secondary
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.
Time frame: from enrollment until completion
Population: due to the character of an observational study: descriptive
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational (Visit 1) | Acceptance of the Drug | poor acceptance | 8.7 percentage of participants |
| Observational (Visit 1) | Acceptance of the Drug | good acceptance | 90.5 percentage of participants |