Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The objective of this study is to retrospectively evaluate the symptomatic effects of crystalline glucosamine sulfate (GS), prescribed for the actually approved indication of knee OA, in addition to conventional therapy, in comparison to the conventional therapy alone in patients with primary hand osteoarthritis (HOA).This is a 6-months retrospective comparative study including patients with concomitant knee and primary HOA, according to the ACR criteria. To be eligible the patients had to present clinical symptoms of hand OA for at least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score of at least 6. Furthermore, the patients have had a radiographic evidence of HOA within the previous 6 months with a Kellgren-Lawrence score of II-III. The participants are stratified into two groups based on whether or not crystalline GS at the daily dose of 1500 mg was added to the conventional therapy for HOA, including exercise, acetaminophen and non steroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase (COX)-2 inhibitors. Primary outcome measures are the difference between the two groups in the change of VAS pain and in the FIHOA, from baseline after 6 months. Secondary outcomes were health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mono or bilateral primary HOA and concomitant knee OA, according to the American College of Rheumatology (ACR) criteria
- •Treatment for at least 6 consecutive months with crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone.
- •HOA 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
- •Radiographic evidence of HOA within the previous 6 months with a radiological score of II-III (using the Kellgren method).
排除标准
- •Erosive Osteoarthritis of the hand
- •Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, monarticular post-traumatic OA of the finger, a history or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis.
- •Ongoing therapy with opioid analgesics and any kind of topical treatment
- •Therapy with SYSADOAs other than GS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months.
- •Contraindications or special warnings for GS presented in the data sheet.
研究组 & 干预措施
Glucosamine Sulfate Group (GS Group)
GS Group is treated for at least 6 consecutive months with a single daily dose of 1500 mg of crystalline GS (powder sachets), in addition to conventional therapy.
干预措施: Glucosamine Sulfate (Drug)
Control Group
Control Group receive only usual care therapy. The conventional therapy includes exercise for HOA and treatment with acetaminophen or oral NSAIDs or COX-2 inhibitors (150 mg Diclofenac tablets, 20 mg Piroxicam tablets, 550 mg Naproxen tablets, 200 mg Aceclofenac, 600 mg Ibuprofen tablets, 200 mg Celecoxib tablets, 60 mg Etoricoxib tablets).
干预措施: Glucosamine Sulfate (Drug)
结局指标
主要结局
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
时间窗: Basal time; one month; three months; six months
0-100 mm scale with 0 representing the absence of pain
次要结局
- Medical Outcomes Study 36-Item Short Form (SF-36)(Basal time; one month; three months; six months)
- NSAIDs and/or acetaminophen consumption(Basal time; one month; three months; six months)
- Difference between the two groups in the change of the Functional Index for Hand Osteoarthritis (FIHOA) score(Basal time; one month; three months; six months)
- Health Assessment Questionnaire (HAQ)(Basal time; one month; three months; six months)
研究者
fioravanti antonella
Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study
University of Siena