The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
114
ATC sa
Liège, Belgium
CIC Clermont-Ferrand, CHU Clermont-Ferrand
Clermont-Ferrand, France
Eurofins Optimed
Gières, France
Clinique Breteche
Nantes, France
Patient's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment
11-point Numeric Rating Scale (NRS); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values.
Time frame: Time zero equals baseline (Day-28 to Day-14) up to Day 36
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)
BPI is a self-reported scale that measures the severity of pain and the interference of pain on function (Charles S. Cleeland © 2009). In the short form of BPI, there are 4 questions assessing worst pain, least pain, actual pain and average pain in the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Time zero equals baseline (Day-28 to Day-14) up to Day 29
Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)
IGAC and PGAC are subjective evaluations using a NRS with 0 meaning "best condition" and 10 "worst condition"
Time frame: Time zero equals baseline (Day-28 to Day-14) up to Day 29
Patient's Change From Baseline of Heat Pain Threshold From Baseline to End of Treatment
celcius degree, arithmetic average of 6 tests.
Time frame: Time zero equals baseline (Day 1) up to Day 29
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This treatment is given as add-on therapy to patient's regular analgesic treatment
This treatment is given as add-on therapy to patient's regular analgesic treatment
Institut Curie
Paris, France
Centre d'Evaluation et Traitement de la Douleur, CHU Saint-Etienne
Saint-Etienne, France
For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment
The WOMAC (Bellamy et al., 1988) is a patient-rated instrument that measures OA symptoms. The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-points Numeric Rating Scale (NRS) between 0-4; from 0=none to 4=extreme. Range of possible subscale scores: pain=0-20, stiffness=0-8 and physical function=0-68; higher scores for each subscale indicate worse outcomes. The WOMAC was completed at each Visit except for Visit 5 by OA patients only.
Time frame: Time zero equals baseline (Day-28 to Day-14) up to Day 29