Erosive Osteoarthritis of the Hand
Conditions
Brief summary
The objective of this study is to evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA). This is a 6-months retrospective study including patients with concomitant gonarthrosis and EHOA, defined as the presence of central erosion in at least two interphalangeal joints. Eligibility criteria are symptoms duration for at least 3 months, with a global hand pain score ≥40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score ≥6. The participants are stratified into two groups based on whether or not pCGS, at the daily dose of 1500 mg, was added to the conventional therapy for hand osteoarthritis (HOA). The latter consists of education and training in ergonomic principles, exercise and the use on-demand of acetaminophen or oral non-steroidal anti-inflammatory drugs. Patients are evaluated at baseline, after 3 and 6 months. Primary outcome measures are the change from baseline to month 6 in VAS and in FIHOA score. Secondary outcomes are duration of morning stiffness, health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36), symptomatic drugs consumption and percentage of treatment responders, according to the OMERACT/OARSI criteria.
Interventions
Treatment for at least 6 months with prescription-grade crystalline Glucosamine Sulfate in addition to conventional treatment
Sponsors
University of Siena
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
48 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
* Erosive Hand Osteoarthritis, defined as the presence of the classical central erosion in at least two interphalangeal joints * Treatment for at least 6 consecutive months with prescription-grade crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone. * Symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 VAS and a FIHOA score of at least 6.
Exclusion criteria
* Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis * Concomitant therapy with SYSADOAs, other than pCGS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months * Concomitant treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months * Contraindications or special warnings for pCGS presented in the data sheet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the two groups in the change of the patient's assessment of global hand pain on a 0- 100 mm Visual Analogue Scale | Basal time; three months; six months | 0-100 mm scale with 0 representing the absence of pain |
| Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score | Basal time; three months; six months | The FIHOA score represents a quantitative measure of functional disability of the hands; it contains 10 items and is an investigator-administered questionnaire. Patients are asked to answer each item using a four-point Likert scale: 0 = possible without difficulty, 1 = possible with slight difficulty, 2 = possible with considerable difficulty, 3 = impossible; the range of scores is 0-30 and the highest values indicate the worst functionality. The validate Italian version of FIHOA is used for the present study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the two groups in the change of SF-36 | Basal time; three months; six months | SF-36 is a widely used measure of health and wellbeing, including two main domains, mental and physical component summary (MCS and PCS respectively), that investigates 8 different areas of perceived health, such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. Scores range from 0 to 100 where 0 indicates the worst condition and 100 indicates the best possible condition |
| Difference between the two groups in the change in the duration of morning stiffness | Basal time; three months; six months | VAS stiffness is measured in minutes and based on the self-report of patients |
| OMERACT/OARSI criteria responders | Basal time; three months; six months | percentage of treatment responders at 3 and 6 months, according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria |
| NSAIDs and/or acetaminophen consumption | Basal time; three months; six months | The acetaminophen and NSAIDs/COX-2 inhibitors consumption was calculated asking the patients at each visit the number of tablets taken weekly. |
| Difference between the two groups in the change of HAQ | Basal time; three months; six months | HAQ is a self administered questionnaire developed to measure disability consisting of 8 sections: dressing arising, eating, walking, hygiene, reach, grip, and activities and ranging from 0 to 3 with a higher score corresponding to worse disability |
Countries
Italy
Outcome results
None listed