chronic low back pain with neuropathic pain component or unclear neuropathic pain
Conditions
Interventions
Trade Name: Qutenza
Product Name: Qutenza
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: capsaicin
CAS Number: 404-86-4
Other descriptive name: CAPSAICIN
Concentration unit: mg milligram(s)
Sponsors
Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible for the study if all the following apply: 1. Men or women > 18 years. 2. Low back pain of all types with or without irradiation for 3 months or more. 3. Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10. 4. Pain Detect Score > 13. 5. No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day. 6. Intact skin surface at the potential patch application site. 7. Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination. 8. The participant has given written informed consent 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Subjects are eligible for the study if all the following apply: 1. Men or women > 18 years. 2. Low back pain of all types with or without irradiation for 3 months or more. 3. Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10. 4. Pain Detect Score > 13. 5. No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day. 6. Intact skin surface at the potential patch application site. 7. Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination. 8. The participant has given written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We want to demonstrate the efficacy of a single skin treatment with capsaicin 8% patch (Qutenza®) in patients suffering from low back pain with a neuropathic pain component according to the classification of symptoms with the Pain Detect questionnaire (scores > 18, neuropathic pain) compared to patients without a clear neuropathic pain component (scores = 18 -13).;Secondary Objective: We further test the hypothesis, that the presence of heat hyperalgesia of the low back skin is a positive predictor of responsiveness. We further test the hypothesis, that the presence of mechanical hyperalgesia of the low back skin is a positive predictor of responsiveness ;Primary end point(s): Mean change of pain intensity from baseline to 4 weeks after treatment on the NRS between the two treatment groups.;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mean change of pain intensity from baseline after 1 week, 8 and 12 weeks on the NRS. 2. Responsiveness to treatment (more than 30% pain reduction at 4 weeks after treatment). 3. Percentage of responders of patients with and without heat hyperalgesia in the respective treatment group. 4. Percentage of responders of patients with and without mechanical hyperalgesia in the respective treatment group. ;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months after treatment | — |
Countries
Austria
Contacts
Public ContactAbteilung für Anästhesie, Intensiv-
Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien
Outcome results
None listed