Acute upper or low back pain as described in the note for guidance on clinical investigation of medical products for treatment of Nociceptive Pain (CPMP/EWP/612/00. Nov. 21, 2002) MedDRA version: 9.1 Level: LLT Classification code 10000683 Term: Acute back pain
Conditions
Interventions
Trade Name: Kytta-Balsam f
Pharmaceutical Form: Cream
Other descriptive name: comfrey root extract
Concentration unit: g gram(s)
Concentration number: 35-
CAS Number: 93-60-7
Other descriptive name: M
Sponsors
Merck Selbstmedikation GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range 18-45 years. 2. Good general condition. 3. Written informed consent. 4. Acute back pain (either upper or low back pain), not in combination. 5. Sensitivity to algometric pressure on the site contralateral to the painful trigger point at least 2.5 N/cm². 6. Back pain on active standardised movement of at least 50 mm on a 100 mm Visual Analogue Scale, (VAS). 7. Basic value of the pressure algometry on the trigger point shall not exceed 50% of the respective value of the site contralateral to the painful trigger point. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Upper or low back pain that is attributable to any identifiable cause (e. g. disc prolapse, spondylolisthesis, osteomalacia, or inflammatory arthritis). 2. Any recent trauma. 3. Any recent strains of the back muscles documented by the clinical evaluation and anamnesis. 4. Chronic back pain. 5. Likelihood of prolapsed spinal disc documented by clinical symptoms (pain irradiation to peripheral areas, paraesthesia, clinically detectable impairment of muscle strength of related areas). 6. Back pain caused by metabolic or neurological diseases documented by anamnesis (i.e. toxic neuropathy). 7. Diabetes Mellitus. 8. Risk factors for spinal infection. 9. Recent onset of bladder dysfunction or severe or progressive neurological deficit in the low extremity (as a possible indication of prolapsed disk). 10. Concomitant use of any anti-inflammatory drugs, heparinoids or analgesics including herbal preparations (glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis). 11. Analgesics or NSAIDs applied by any route of administration within 10 days of study entry or corticoid drugs applied by any route of administration within 60 days of study entry. 12. Any other concomitant treatment or medication that interferes with the conduct of the trial. 13. Known intolerance or hypersensitivity (allergy) to comfrey extract, peanut, soya, methyl nicotinate, parabenes or one of the other ingredients of the trial treatments, including known toxic reactions. 14. Local skin affections that do not allow the application of the test cream. 15. Participation in a clinical trial within the previous 30 days before enrolment in the trial, participation in this study before or simultaneous participation in another clinical trial. 16. Pregnancy or lactation period. 17. Women with childbearing potential without an effective contraceptive method. 18. Abuse of alcohol, medicaments or illicit drugs. 19. Any patient in the investigator’s opinion not considered suitable for enrolment. 20. Legal incapacity or limited legal capacity to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to show that Kytta-Balsam® f (a combination of comfrey root extract plus methyl nicotinate) is superior to the single preparation of methyl nicotinate or placebo cream as assessed by time-specific pain intensity difference in the indication of acute upper or low back pain. The primary efficacy variable is the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at Visits 1 to 4 (at actual measurement times).;Secondary Objective: The secondary objectives of this trial are: · Back pain at rest, assessment by patient on Visual Analogue Scale (VAS). Rationale: besides pain of active motion VAS at rest is another alternative to measure Nociceptive Pain in back pain. · Pressure algometry (pain-time curve; AUC over 5 days). Rationale: algometric pain measurement is a relevant and highly sensitive surrogate parameter for the assessment of pain, which has been used in the identification of trigger points and evaluation of pain sensitivity . Because of its reliability and reproducibility algometry is used in objective medico-legal documentation of pain intensity. · Global assessment of efficacy by patient. · Global assessment of efficacy by the investigator. · Consumption of rescue medication. Rationale: consumption of analgesics is an indirect parameter for the efficacy of the treatment. · Functional impairment measured with the Oswestry Disability Index.;Primary end point(s): The primary efficacy variable is the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at Visits 1 to 4 (at actual measurement times). | — |
Countries
Germany
Outcome results
None listed