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临床试验/NCT01775670
NCT01775670终止不适用

Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Average Satisfaction With the Splint 2 Months After Enrollment

研究概览

简要总结

The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.

详细描述

Trapeziometacarpal (TMC) arthrosis is so common, particularly in women, that it should be considered a normal part of the aging process. Overall radiographic prevalence of TMC arthrosis has been described to be as high as 91% in patients older than eighty years of age. It increases steadily from the age of 41 years, more rapidly in women than in men. Another study, conducted in the Netherlands, showed that in a population of 55 years and older, 67% of women and 55% of men had radiographic signs of arthrosis of the hand. It also found that the distal interphalangeal (DIP) joints are most commonly affected (47%), followed by the TMC joint (36%). However, it has been reported that in symptomatic arthrosis, TMC arthrosis contributes more to pain and disability than arthrosis of the interphalangeal joints. Psychosocial factors have been recognized as the strongest determinants of highly variable pain intensity and arm-specific disability. The pathophysiologic and psychosocial differences between patients who present to the doctor for treatment and those who do not are incompletely understood.

A hand-based thumb spica splint with the interphalangeal (IP) joint free is a specific nonoperative palliative treatment for TMC arthrosis. The goals of splint wear are improved comfort and function. The data regarding specific splint materials are limited, but suggest that shorter more flexible splints are preferred by patients and equally effective. Recently, the investigators looked into if there was a difference between thermoplast and neoprene hand-based thumb spica splints for treatment of TMC arthrosis. The neoprene splint was rated more comfortable than the thermoplast splint but otherwise there was no difference.

To the investigators' knowledge no studies have looked at the added value of occupational therapy in splint treatment for TMC arthrosis. The investigators believe that the time spent by occupational therapists (OTs) coaching patients on adaptive and palliative measures is valuable in addition to their technical skills but the investigators cannot draw any conclusions until the investigators research this in a prospective trial.

The investigators propose a two arm unblinded, randomized (1:1) controlled trial to evaluate if there is a difference between prefabricated off-the-shelf splints and splints provided by an OT with standard care coaching. The investigators want to determine if there is a difference in arm-specific disability, average pain, and satisfaction at an average of 2 months between splints provided by an OT and prefabricated off-the-shelf splints.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40 years of age and older
  • Clinical or radiological diagnosis of TMC arthrosis by MD
  • English fluency and literacy

排除标准

  • Prior surgical treatment of TMC arthrosis on same side
  • Prior treatment of TMC arthrosis on same side with a splint during the last two months
  • Prior injury of the trapeziometacarpal joint
  • Rheumatoid arthritis
  • Pregnant women.

结局指标

主要结局

Average Satisfaction With the Splint 2 Months After Enrollment

时间窗: At 2 months after enrollment

Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.

Average Pain 2 Months After Enrollment

时间窗: At 2 months after enrollment

Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.

Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)

时间窗: At enrollment

The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.

Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment

时间窗: 2 months after enrollment

The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.

Thumb Pain at Enrollment

时间窗: At enrollment

11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.

次要结局

  • Patient Reported Outcomes Measurement Information System (PROMIS) - Depression(At Enrollment)
  • PROMIS Pain - Interference(At Enrollment)
  • Thumb Pinch Strength(At Enrollment)
  • Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)(At Enrollment)
  • Thumb MCP in Pinch Position (Degrees)(At Enrollment)
  • Thumb Grip Strength(At Enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David C. Ring, MD

Principal Investigator

Massachusetts General Hospital

研究点 (2)

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