Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of appointments issued by orthotists
研究概览
简要总结
Consenting patients with multiple myeloma (MM) will be randomly allocated to receive either standard medical treatment (chemotherapy, radiotherapy, pain-killing medication) alone or standard medical treatment plus a brace. Patients will be regularly evaluated in research clinics; the results data will inform the design of a full trial. Information will be collected to inform a list of requirements a centre needs to have in place to run an RCT of these interventions.
详细描述
Multiple myeloma (MM) is a neoplasia of plasma cells mostly within the bone marrow, commonly leading to multiple vertebral collapses. This causes spinal deformity, leading to incapacitating back pain and reduced quality of life. In spite of advances in medical therapy, some patients are left with disabling back pain, sometimes requiring surgical intervention. University Hospitals of North Midlands NHS Trust have observed on an audit of our own practice that application of an external spinal brace as early in the disease process as is possible appears to maintain the overall alignment of the spine, thus minimising risk of spinal deformity and consequent back pain.
The ultimate aim is to undertake an RCT to determine whether the use of an external spinal brace can reduce back pain and spine-related disability in patients suffering from back pain due to multiple myeloma, in comparison to conventional management without a brace.
However, prior to this, a feasibility study is required. The feasibility study is needed to see if the trial processes (providing patient information, consent process, conducting the baseline investigations and outcome measures) can be accommodated without causing too much delay to the application of the brace.
Suitable patients will be consented by the research team and randomised to receive a brace or no brace in addition to their routine Myeloma treatment. After baseline data collection and questionnaires, the participant would be followed up for data collection at 6 weeks and 3 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with MM
- •Myeloma infiltration in the spine confirmed by radiological evidence
- •MM-related back pain
- •Can attend for the whole follow up period
排除标准
- •Presenting with cord compression and neurological deficit requiring urgent decompression and intervention
- •Chronic pain syndrome
- •Language barrier that cannot be overcome using translation services
- •Unwilling or unable to give informed consent
- •Painful VCFs at the lumbosacral junction, L4 to Sacrum, where application of brace is not possible.
- •Not suitable for treatment with a brace e.g. pregnancy
研究组 & 干预措施
Standard care + brace
Spinal brace (thoracolumbosacral orthosis or cervico-thoraco-lumbar orthosis) to be fitted to the participant in addition to receiving standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates
干预措施: thoracolumbosacral orthosis or cervicothoracolumbar orthosis (Device)
Standard care + brace
Spinal brace (thoracolumbosacral orthosis or cervico-thoraco-lumbar orthosis) to be fitted to the participant in addition to receiving standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates
干预措施: Standard care (Other)
Standard care
Participant will receive standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates
干预措施: Standard care (Other)
结局指标
主要结局
Number of appointments issued by orthotists
时间窗: 21 months
Time from diagnosis to brace fitting for patients randomised to the intervention group
时间窗: Assessed at 3 months
Are appropriate braces fitted
时间窗: 6 weeks
The locations and levels of VCFs and back pain in patients and the type of brace fitted will be recorded to determine whether appropriate braces are fitted.
Number of patients in the intervention arm who request additional support from the orthotic team and time they had to wait for support.
时间窗: assessed at the end of study at 21 months
The number of orthotists in each hospital
时间窗: 21 months
Frequency of appointments issued by orthotists
时间窗: 21 months
次要结局
- The number of patients that drop-out during follow-up and their reasons(21 months)
- Qualitative assessment of semi structured interviews in a sub-set of participants, EQ-5D-5L(21 months)
- Disability measured by ODI(6 weeks and 3 months)
- The number of missing cases for a subsequent RCTs co-primary outcomes of pain and disability(21 months)
- Pain measured by VAS(6 weeks and 3 months)
- The number of new MM cases at each centre(1 year)
- The number of eligible patients who give consent to enter the study(21 months)
- Descriptive statistics and qualitative analysis of the 3-month follow up patient questionnaire(3 months)
- The number of patients who receive non-study-related interventions during the 3 month follow-up period(3 months)
- Number of patients eligible for the study during 1 recruitment year.(1 year)