PICASSO has been designed to demonstrate that combination therapy with CS/GH has superior efficacy compared to placebo in pain reduction (average score reduction in Huskisson's 0 to 100 mm Visual Analogue Scale) from baseline to 6 months of treatment in patients with symptomatic hand osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
Unnamed facility
Barcelona, Spain
RECRUITINGHuskisson's VAS
Huskisson's Visual Analogue Scale of pain. Score Range: 0 (no pain) - 100 (maximum pain) The study was designed such that the outcome of primary interest is hand pain related to OA. The measure selected to best evaluate this is an improvement in the VAS pain.
Time frame: 6 months
FIHOA Index
The FIHOA Index is a semi-quantitative questionnaire administered by the doctor or self-administered by the patient. If necessary, it is the questionnaire can be hetero-administered; investigator can assist the patient in understanding and completing the FIHOA. The questionnaire consists of 10 questions that score between 0 and 3 points (total range of 0-30) assessing the dexterity of the patient suffering from symptomatic Hand Osteoarhritis.
Time frame: 6 months
Changes in grip strength
Grip strength in the study hand of the patient will be measured with a dynamometer. Patients sitting up in a chair supporting straight his/her back, in a position that allows hips and knees are at right angles; They flex the elbow at 90 ° between pronation and supination. Patients will be asked to squeeze the dynamometer as strong as they could according to their individual pain limits. This procedure will be repeated 3 times, with a break of 10 seconds between each of the measurements. The average value of these 3 measurements will be registered as the value for the parameter in the study.
Time frame: 6 months
Duration of morning stiffness
The time in minutes that it took from the patient waking up in the morning until they felt that joint stiffness in the hand had diminished significantly.
Time frame: 6 months
Patient's global assessment of disease activity
Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: "Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing." Left hand marker "Very Well", Right hand marked "Very Poor".
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Time frame: 6 months
Patient's global assessment of response to treatment
The patient will be asked to score the overall response to the study drug in the hand, placing a vertical line (\|) on a 100 mm VAS in the following way: If they mark the left edge (0 mm), it means " none, poor response, ineffective " and if they mark on the right edge (100 mm), it means " excellent, ideal response, virtually pain-free".
Time frame: 6 months
EuroQoL-5D
EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits. The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. Total scale range for VAS dimension reported is 0 to 100.
Time frame: 6 months
HAD scale
The Hospital Anxiety and Depression (HAD) questionnaire aims to determine the emotional state of the patient, as the importance of emotional factors is well-recognised in the majority of diseases. It consists of 14 items, and each item is assigned a score of 0, 1, 2 or 3. The scores are added together and between 0 and 7 means there is no case, between 8 and 10 is a borderline case and scores above 11 are, likely, cases in each one of the sub-scales
Time frame: 6 months
Consumption of Rescue Medication
Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary. Total Number of pills per month
Time frame: 6 months