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临床试验/NCT02435979
NCT02435979已完成不适用

Proximal Strengthening for the Management of Wrist Pain: A Randomized Controlled Trial

Mitchell Selhorst8 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
8
主要终点
Change in Patient Rated Wrist Evaluation (PRWE) score

研究概览

简要总结

This study will be a randomized controlled trial comparing proximal strengthening vs. traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy sessions per week for 4 weeks. Change in patient function and pain as measured by the patient rated wrist evaluation will be the primary outcome of interest

详细描述

This will be a non-blinded randomized controlled trial using a sample of consecutive patients with wrist pain. Patients who are referred to Nationwide Children's Hospital Hand therapy clinics with a primary complaint of wrist pain will be considered for this study.

Patients will be randomly assigned to one of two treatment groups; The proximal strengthening group or Traditional Hand Therapy Group. Both treatment groups will be evaluated and treated by the certified hand therapists for 2 sessions per week for 4 weeks. Both groups will receive similar treatment durations of 45-60 minutes per session based on each patient's individual needs.

Proximal strengthening group-The experimental proximal strengthening group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 20-30 minutes at each treatment session. Patients allocated to this treatment group will also perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises. Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.

Traditional Hand Therapy Group This active comparator group consists of treatment where the hand therapist address specific impairments at the wrist and hand for 45-60 minutes at each treatment session. Treatment can include stretching, motion, and strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase. Modalities for pain control and tissue mobility, and bracing or splinting if necessary. All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.

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
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Wrist pain

排除标准

  • <8 years of age
  • any neurological disorder
  • Juvenile rheumatoid arthritis
  • juvenile idiopathic arthritis
  • Wrist fractures < 16 weeks from date of injury or surgery
  • Tendon repair
  • Nerve injury or repair
  • Inability to follow directions
  • Inability to attend follow-up appointments

研究组 & 干预措施

Proximal strengthening + hand therapy

Experimental

Patients in this group will perform traditional hand therapy for 30 minutes and proximal strengthening of the core, cervical spine, and shoulder complex for up to 30 minutes

干预措施: hand therapy (Other)

Proximal strengthening + hand therapy

Experimental

Patients in this group will perform traditional hand therapy for 30 minutes and proximal strengthening of the core, cervical spine, and shoulder complex for up to 30 minutes

干预措施: Proximal Strengthening (Other)

Traditional hand therapy

Active Comparator

This group will receive traditional hand therapy for 45-60 minutes each session.

干预措施: hand therapy (Other)

结局指标

主要结局

Change in Patient Rated Wrist Evaluation (PRWE) score

时间窗: 4 weeks (From initial evaluation to discharge)

The PRWE is a 15 item self-report questionnaire which measure pain and function. It has been found valid and reliable for measure changes in pain and function for patients with wrist pain. The minimal clinical important difference of this scale is 14 (Sorensen, 2013).

次要结局

  • Change in Grip Dynamometer strength(4 weeks (From initial evaluation to discharge))

研究者

发起方
Mitchell Selhorst
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mitchell Selhorst

Principal Investigator

Nationwide Children's Hospital

研究点 (8)

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