The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Pelvic ring fractures in the geriatric population are a rising problem for surgeons in industrialized countries. Many of these low-energy fractures are treated nonoperatively; however, pain is a significant factor in recovery of these patients and often inhibits their ability to mobilize. Most of these fractures are lateral compression type 1 injuries which are defined as an impaction to the sacrum with varying amounts of anterior/pubic root/rami fractures. Many of these patients in the geriatric population suffer from osteoporosis and the injuries are often sustained from a low-energy mechanism like a fall. The tenet of treatment for all osteoporotic fractures is early mobilization. It is well known that extended periods of bed rest will lead to pneumonia, decubitus ulceration, deep venous thrombosis, and, in the case of the pelvis, not prevent subsequent deformity. Calcitonin is a polypeptide containing 32 amino acids, and it plays a role in the regulation of bone metabolism as a hormone that prevents bone resorption. Intranasal salmon calcitonin (ISC) has been demonstrated to decrease pain and improve the level of activity in patients with acute vertebral osteoporotic compression fractures when administered within the first 5 days of onset of pain/injury. It has also demonstrated an immediate post analgesic effect in osteoporotic distal radius fractures treated nonoperatively. The antihyperalgesic action of calcitonin appears to be mediated by serotonin receptors. The purpose of this study is to evaluate the analgesic effect of ISC on geriatric patients with pelvic ring injuries who are treated nonoperatively.
详细描述
Baseline: Treatment group will be prescribed 200IU of ISC daily for a period of 3 months. The control group will not be prescribed calcitonin. Participants will complete research only Iowa pelvis score questionnaire, SF-36 questionnaire and visual analogue scale (VAS) to assess subjective pain and function. Two-week follow up visit post discharge: participants will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function. Participants will be referred for a standard of care DEXA bone density scan if they have no previous diagnosis of osteoporosis and no history of previous scan within a year. Six weeks post discharge: participants will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function. Participants will undergo standard of care radiographic analysis of pelvic ring injury with AP/inlet and outlet pelvic x-rays 4. Twelve weeks post discharge: Participants will complete Iowa pelvis score questionnaire, SF-36 questionnaire and VAS to assess subjective pain and function. Participants will undergo standard of care radiographic analysis of pelvic ring injury with AP/inlet and outlet pelvic x-rays - Participants will perform a timed up and go (TUG) test.
After informed consent is obtained, all patients who meet eligibility criteria will be randomized into one of two groups. Randomization will be achieved by numbering 50 sealed white envelopes (25 control, 25 treatment). There is no blinding to the randomization. It would be difficult to blind the participants, or the research personnel. We do not believe there will be any significant bias that can be corrected with blinding.
Treatment: 200IUof ISC daily for a period of 3 month
Control: Will not be prescribed calcitonin (ISC)
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females over the age of 65 who sustain isolated pelvic ring injuries via a low-energy mechanism
排除标准
- •An open pelvic ring fracture
- •Concomitant acetabular fracture
- •They are on ISC prior to enrollment
- •Allergic or have contraindications to calcitonin or salmon
- •Sustain other injuries in their spine or lower extremities
- •Unwilling to participate in the study
- •Nonambulatory at baseline
- •Neurologic deficit associated with the pelvic ring injury
研究组 & 干预措施
Miacalcin Calcitonin Salmon Nasal Spray
1 spray (200 IU) qDay, alternate nostrils daily
干预措施: Miacalcin Calcitonin Salmon Nasal Spray (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: The subject will be enrolled/assessed up to three months post-injury.
Compare acute pain using (Visual Analogue Scale on a scale of 0-10 with 0=no pain and 10= worst pain imaginable.
次要结局
- Iowa Pelvic Score (IPS)(The subject will be enrolled/assessed up to three months post-injury.)
- SF-36 Short Form Health Survey(The subject will be enrolled/assessed up to three months post-injury.)
- Radiographic Healing Using Intranasal Salmon Calcitonin(Fracture healing and alignment will be assessed at six weeks and three months post-injury.)
- Timed Get Up and Go (TUG)(The subject will be assessed at the three months post-injury)
研究者
Brett D. Crist
Associate Professor
University of Missouri-Columbia