Low-Carbohydrate Diet to Reduce Pain and Increase Quality of Life in Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- BPI Pain Severity Change
研究概览
简要总结
Phantom limb pain (PLP) is defined as pain or discomfort in a missing limb following amputation, whereas residual limb pain (RLP) is often experienced as pain at the site of amputation. Unfortunately, PLP can affect as many as 80% of upper- or lower-extremity amputees, with 40-60% also experiencing RLP. There are many theories regarding the mechanisms underlying these types of pain, but effective treatments remain elusive .Amputation of a limb is often accompanied by a traumatic event that can be emotionally devastating. Consequently, studies have reported high levels of depression in this population, up to 80%. Other studies have reported elevated levels of depression (70%), suicidality (30%) and posttraumatic stress disorder (PTSD, 20%) with PTSD being highly correlated with PLP. Thus, it is critical that effective treatments be employed that address, not only the chronic pain, but the comorbid conditions as well.
Diet interventions have been utilized as a non-pharmacological method to reduce pain and/or inflammation. We have shown that a low-carbohydrate diet (LCD) reduced pain independent of weight loss. Importantly, we observed a reduction in depressive symptomology and improved quality of life (QOL) following the LCD. Thus, it is reasonable to expect that the LCD may have beneficial effects of pain experience and also on measures of QOL.
Phase 1: To characterize the dietary habits, pain severity and psychological well-being of the local amputee population.
Hypotheses: We expect that the local population will show high prevalence of phantom limb pain (PLP) and/or residual limb pain (RLP). Self-report of depressive symptomology, poor-quality diet, will coincide with low QOL reports.
Phase 2: To assess the feasibility and efficacy of a low-carbohydrate diet (LCD) to reduce pain and increase QOL in amputees.
Hypotheses: All participants will complete the 6-week LCD. Compared to baseline, a 6-week LCD will reduce self-reports of pain and depressive symptoms. Overall QOL will improve over 6 weeks with concomitant improved mood and sleep.
详细描述
Phase 1: Baseline Demographics
Participants: We expect to recruit 40 participants (male or female, aged 18-65 years) for Phase 1. Inclusion criteria will be: PLP/RLP for at least 6 months (>4/10 on visual analogue scale), amputation at least 6 months prior. Exclusion criteria will include: inability to read/understand English, current infection at amputation site. We will collect clinical data related to amputation (cause, date, affected limb, level) and sociodemographic information (sex, gender, race, income, education, employment status etc.), in addition to a 24-hour diet recall to assess regular diet habits. Furthermore, we will collect the following:
Pain-Related Questionnaires: Chronic PLP/RLP will be assessed using the Brief Pain Inventory (BPI), Neuropathic Pain Questionnaire (NPQ), and the McGill Pain Questionnaire - Short Form (MPQ-SF). The BPI is used to assess the severity of pain and the degree to which that pain interferes with daily activities. This inventory also allows for reports on medications used to treat pain. The NPQ is specific to the type of pain commonly experienced in PLP/RLP, consisting of sensory, affective and sensitivity measures. The MPQ-SF is a standard metric whereby patients can select descriptors to categorize their pain experience more fully across sensory, affective, and evaluative dimensions.
QOL-Related Questionnaires: The Short-Form 36 (SF-36) measures general health status and quality of life across eight domains that are relevant to assessment of a diet intervention. Depression and mood will be assessed using the Center for Epidemiological Studies - Depression (CES-D) scale. The CES-D assesses depression as well as sleep, appetite and loneliness and can be used to identify those at risk for clinical depression (score >16). Higher scores indicate more depressive symptoms. We will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess self-reported sleep. We believe that the LCD will increase restful sleep. The Nottingham Extended Activities of Daily Living Scale (NEADL) assesses regular household and leisure activities and has been used to measure QOL in amputees.
Psychological Questionnaires: The Acceptance and Action Questionnaire (AAQ) will be used to assess psychological flexibility. The Cognitive Flexibility Scale (CFS) will assess cognitive flexibility through ratings of agreement with 12 statements. The Multidimensional Psychological Flexibility Inventory (MPFI) will assess multiple domains of cognitive flexibility. The Pain Resilience Scale (PRS) will be used as a specific means to investigate resilience (behavioral perseverance and cognitive positivity) for those with chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Amputation at least 6 months prior
排除标准
- •Inability to read/understand English
- •Active infection at amputation site
- •Phase 2 Inclusion Criteria:
- •PLP/RLP for at least 6 months (>4/10 on visual analogue scale)
- •Amputation at least 6 months prior
- •Phase 2 Exclusion Criteria:
- •Inability to read/understand English
- •Current infection at amputation site
- •Unmedicated diabetes
- •Unwillingness to follow prescribed diet
- •Recent weight change (>4 kg in past month)
- •Currently on a prescribed diet or consuming less than 100 g of daily carbohydrates
- •History of eating disorders or other psychiatric disorders requiring hospitalization within the past 6 months
- •Digestive diseases
- •Difficulty chewing or swallowing
- •Reliance on others for meal preparation
- •Uncontrolled cardiovascular or pulmonary disease
- •Daily opioid pain medications
- •Use of medications known to alter metabolism or digestion (e.g., proton-pump inhibitors)
- •Use of anti-hypertensive medications that affect glucose tolerance
- •Participation in extreme exercise
结局指标
主要结局
BPI Pain Severity Change
时间窗: Baseline (week 0), immediately after the intervention (week 6)
BPI pain severity is an average score out of 10.
BPI Pain Interference Change
时间窗: Baseline (week 0), immediately after the intervention (week 6)
BPI pain interference is an average score from 9 items out of 10.
SF-36 overall score change
时间窗: Baseline (week 0), immediately after the intervention (week 6)
The Short Form 36 (SF-36) quality of life score is a 0-150 score with higher scores reflecting poorer quality of life. Scores in each of the 7 sections (general health, limitations, physical health, emotional health, social activities, pain and energy) are summed to provide an overall quality of life score. Change scores will be calculated.
次要结局
- NPQ score change(Baseline (week 0), immediately after the intervention (week 6))
- PSQI change score(Baseline (week 0), immediately after the intervention (week 6))
- AAQ change score(Baseline (week 0), immediately after the intervention (week 6))
- PRS total and subscale score change(Baseline (week 0), immediately after the intervention (week 6))
- CES-D score change(Baseline (week 0), immediately after the intervention (week 6))
- PROMIS-57 domain change(Baseline (week 0), immediately after the intervention (week 6))
- CFS score change(Baseline (week 0), immediately after the intervention (week 6))
- MPFI score change(Baseline (week 0), immediately after the intervention (week 6))
- NEADL change score(Baseline (week 0), immediately after the intervention (week 6))
研究者
Robert Sorge
Associate Professor
University of Alabama at Birmingham