Routine Exercises and Either a Psychological (Therapy-based) or a Placebo (Informational) Intervention Workbook After Distal Radius Fracture: A Double Blind Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Disability of Arm Shoulder and Hand
研究概览
简要总结
A randomised controlled trial to compare two different rehabilitation work books used in patients with wrist fracture.
详细描述
Participants
A total of 140 participants aged over 18 with distal radius fractures will be included in the study.
Sample Size The primary outcome used to calculate a sample size was the Disability of Arm Shoulder and Hand (DASH) Score. In a pilot study of sixty patients with distal radius fracture who were evaluated 8 weeks following fracture, the mean DASH score was 29 and the standard deviation was 19. A sample size of 126 would therefore provide power (90%) to identify true superiority of intervention workbook over current practice with a difference between the means equal to 10 (recognised minimal clinically significant difference in DASH) as significant at the 5% level (using a one sided test). We anticipate a drop out rate of 10% and will therefore aim to enrol 140 patients into the study. (70 in each arm).
Treatment and Rehabilitation Overview All patients will be routinely discharged from the Emergency Department following application of a cast or manipulation and application of a cast and followed up in the orthopaedic outpatient clinic. They will be treated operatively or in cast for 6 weeks (this treatment decision will be made on a clinical basis by the named consultant orthopaedic trauma surgeon responsible for the patient's care) before beginning mobilisation. All treatment types will be included in the study as no significant differences were seen between groups in terms of patient reported outcome or psychological scores in pilot study of 60 patients. Recruitment and randomisation will take place in the outpatient department at 2 weeks following injury. At this stage patients will be given one of the workbooks and instructed on how it should be used. Patients will not routinely be referred to physiotherapy but should individual patients develop a complication for which physiotherapy is clinically indicated they will be referred at this stage. Patients will be followed up at 6 weeks and 6 months following injury. The only deviation from normal practice in this trial will be the administration of the workbooks which patients will complete in their own time at home. In routine practice some patients would be followed up to 6 months, in this trial all patients will be.
Recruitment
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated distal radius fracture undergoing management with manipulation and cast / cast alone / operative management.
- •Age 18 and over. No upper age limit
排除标准
- •Cognitive impairment preventing completion of patient reported questionnaires
- •Non English speaking
- •Temporary residents unable to attend follow-up
- •Patients lacking capacity to consent and patients who loose capacity during the trial.
- •Paediatric fractures in skeletally immature patients.
- •Presentation and recruitment > 3 weeks after injury
- •Patients with > 1 fracture at time of injury
研究组 & 干预措施
Psychological Workbook
Psychological work book containing information and activities aimed at improving outcomes.
干预措施: Psychological workbook (Other)
Basic information workbook
Basic information which represents current practice
干预措施: Basic information workbook (Other)
结局指标
主要结局
Disability of Arm Shoulder and Hand
时间窗: 6 months
Patient reported outcome measure validated for upper limb injuries.
次要结局
- Objective wrist function(6 months)
- Patient satisfaction(6 months)
- Illness Perception Questionnaire - revised(6 months)
- Complications(6 months)