Comparative Study of the Intraarticular Treatment of Carpometacarpal Joint Ostearthritis of the Thumb With Lavage With Saline Solution, or Lavage and Injection of Hyaluronic Acid and Mannitol.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in grip strength at 6 months
研究概览
简要总结
Although a common problem, hand osteoarthritis (HOA) is less studied than knee and hip. In the age group of 71-100 years, the prevalence of symptomatic HOA reaches 26% of women and 13% of men. These patients lose hand strength and have difficulty with day-to-day manual activities. The main joints involved are the proximal and distal interphalangeals and the carpometacarpal joint of the thumb. In the educational Project PARQVE, the prevalence of HOA was 23.7% at inclusion in the program, and 47.4% after one year, with loss of grip strength. There is controversy over the effect of viscosupplementation in the treatment of rhizarthritis when considering pain. However, strength is a very important function parameter that must be evaluated for function and quality of life maintenance. Concerned about the importance of maintaining strength and function in our program (PARQVE), we have added specific exercises tom improve hand strength and range of motion. Trying to optimize the treatment and confronting questions about the effect of the joint wash, called placebo in the comparative studies with corticosteroid and/or hyaluronic acid injection, we did a work where all the patients will be washed with physiological saline solution but a group, after emptying, will receive 1mL of hyaluronic acid with mannitol.
PURPOSE: To compare isolated lavage with lavage followed by injection of hyaluronic acid with mannitol into carpometacarpal osteoarthritis joint of the thumb.
METHODS: Forty joints of patients with multiple osteoarthritis (rhizoarthritis, including) and comorbidities (two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, hypertension) will be allocated into two groups: Lavage (LS) and Lavage and Injection Hilauronic acid (LO). Both groups will undergo joint lavage with saline solution. The LO group will receive the 20 mg / mL hilauronic acid injection with 5mg mannitol. Both groups will be guided in the clinical treatment of osteoarthritis and metabolic syndrome and will be given daily exercises for the hands. They will be evaluated with the quick DASH questionnaire, Sollerman Test and by measuring the palmar, lateral and pulp-pulp grip strength, in addition to measuring the ROM and VAS pain moments immediately prior to the procedure, one, three and six months after the articular procedure.
详细描述
Patients with multiple osteoarthritis (including carpometacarpal joint of the thumb, stages I to III - Eaton et al.) in treatment at the Institute of Orthopedics and Traumatology fo the Clinics Hospital - University of São Paulo (IOT-HC-FMUSP) will be invited to participate in this study.
All patients are obliged to participate in a two-day education course on OA. During the program they are instructed about OA, metabolic syndrome, comorbidities and importance of diet, and daily exercise (including specific exercises for the hand).
After inclusion, 40 joints will be randomized in one of two treatment options, i.e., Lavage with saline solution and final injection of 1mL of saline solution, or lavage with saline solution followed by injection of 10mg of hyaluronic acid with mannitol (5mg).
After the procedure patients will receive naproxen 500mg twice daily for 5 days.
Patients will be instructed to exercise at least 180 minutes/week and if possible daily exercise for the hand (5 to 10 minutes daily).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women diagnosed with multiple arthritis (including CMC OA of the thumb) with comorbidities (metabolic syndrome, i.e., OA and overweight / obesity, and/or hyperglycemia, and/or dyslipidemia, and/or hyperuricemia, and/or hypertension).
- •CMC OA joint of the thumb stages I to III as classified by Eaton et al. (4)
排除标准
- •Missing classes or functional evaluations
- •Not performing the exercises as instructed
研究组 & 干预措施
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Visual Analog Scale (VAS) (Behavioral)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Range of Motion (ROM) (Behavioral)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Palmar grip strength (Behavioral)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Lateral grip strength (Behavioral)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Pulp-pulp pinch strength (Behavioral)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Lavage with physiologic saline solution (Drug)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Quick Dash (Behavioral)
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Sollerman Test (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Visual Analog Scale (VAS) (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Range of Motion (ROM) (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Palmar grip strength (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Lateral grip strength (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Pulp-pulp pinch strength (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Lavage with physiologic saline solution and Osteonil® Mini (Drug)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Quick Dash (Behavioral)
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
干预措施: Sollerman Test (Behavioral)
结局指标
主要结局
Improvement in grip strength at 6 months
时间窗: Baseline, 1 month, 3 months and 6 months.
Perform test and collected data in baseline, 1 month, 3 months and 6 months.
次要结局
- Assess improvement in pain(Baseline, 1 month, 3 months and 6 months.)
- Assess improvement in range of motion(Baseline, 1 month, 3 months and 6 months.)
- Assess improvement in palmar grip strength(Baseline, 1 month, 3 months and 6 months.)
- Assess improvement in lateral pinch strength.(Baseline, 1 month, 3 months and 6 months.)
- Assess improvement in Pulp-pulp pinch strength(Baseline, 1 month, 3 months and 6 months.)
研究者
Marcia Uchoa Rezende
MD; PhD
University of Sao Paulo General Hospital