The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
This trial is a French, multicenter, randomized, controlled, bouble-blind and prospective study. Patients enrolled will be clinically followed for 5 months. The treatment duration per subject is 1 hour (1time).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
1 patch applied once for 1 hour
1 patch applied once for 1 hour
Brest University Hospital
Brest, France
RECRUITINGVendée Departmental Hospital
La Roche-sur-Yon, France
RECRUITINGConfluent Private Hospital Centre
Nantes, France
to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
The difference in the proportion of subjects improved (PGIC≤2) in either treatment group at day 60. It is expected that there will be a difference of at least 20% between treatment arms.
Time frame: Day 60
Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days
Tolerability will be assessed by the evolution over time of the pain intensity in standing position in the treated zone as measured on an 11 point numeric rating scale at time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.
Time frame: time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and through study completion (an average of 5 months)
Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.
Safety will be assessed by recording and describing adverse events throughout the study.
Time frame: Throughout the study (an average of 5 months)
Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.
The timecourse of the analgesic effect will be measured by the Patients' Global Impression of Change (PGIC) scale and the area under the pain intensity score in sitting position as measured Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
Time frame: Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
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Nantes University Hospital
Nantes, France
RECRUITINGGH Paris saint Joseph
Paris, France
RECRUITINGRouen University Hospital
Rouen, France
RECRUITINGCare consumption will be assessed over 5 months using the Medication Quantification Scale (MQS), which provides a standardised assessment of consumption of analgesics and co-antalgesics.
Time frame: Over 5 months
Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
Care consumption will be assessed over 5 months using a self-diary in which patients will enter the dates of medical consultations (psychiatry, rheumatology, general medicine, etc.), para-medical consultations and/or complementary medical consultations (physiotherapy, acupuncture, osteopathy, psychotherapy, etc.).
Time frame: Over 5 months
Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months
The evaluation of cost-utility will be assessed as the ratio of the incremental cost-utility (RICU in cost per QALY gained) comparing the treatment with 8% capsaicin patch with usual practice according to the collective perspective and a 5-month horizon. QALYS will be calculated using patients' lifespan and a utility score obtained from responses to the EQ-5D-5L generic quality of life questionnaire.
Time frame: Over a time horizon of 5 months
Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.
Subgroup analysis according to the presence or absence of a sacrococcygeal mobility disorder at inclusion for the primary endpoint and the first two secondary endpoints.
Time frame: At inclusion
Determination of the therapeutic response to 8% capsaicin patch
Measurement of the association between the patient's intrinsic clinical parameters and a therapeutic response to capsaicin defined by a PGIC ≤2.
Time frame: Day 60
Sensitivity study to compare results on the primary endpoint by comparing data from the PGI-C and a comparison of the two numerical pain assessments at Day 0 and Day 60.
Comparison of the classification of patients as success-failure between PGI-C values at Day 60 (success if PGI-C≤2) and numerical pain assessments between Day 0 and Day 60 (success if there is a reduction of at least 2 points on the EN).
Time frame: Between Day 0 and Day 60