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临床试验/NCT07213843
NCT07213843尚未招募不适用

Combined Circulatory and Dietary Interventions for Neuropathy (CDIN)

Loma Linda University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Change in Pain Intensity

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of three different interventions in improving neuropathy symptoms in individuals aged 35-85 with moderate to severe neuropathy. The study will compare three treatment groups: Intraneural Facilitation® (INF®) therapy alone, INF® therapy combined with Neuro vascular index (NVI) food-guided elimination (NVIf), and NVIf alone. The aim is to determine which treatment results in the greatest improvement in neuropathy symptoms, including quality of life, sensory and pain improvements, and functional outcomes.

详细描述

The purpose of this investigator-initiated study is to observe the effectiveness of a manual physical therapy technique known as Intraneural Facilitation (INF®), both independently and in combination with a Nutritional Vascular Inflammation focused (NVIf) dietary intervention, in improving neurovascular function, pain, and physical performance in individuals with moderate to severe peripheral neuropathy (PN). Subjects will be randomized into one of the three interventions arms: (1) INF® therapy alone, (2) NVIf intervention alone or (3) a combination of both. INF® is a manual therapy, while NVIf utilizes ultrasound guided food elimination. Outcomes include pain (Visual analog scale), sensory function (Semmes Weinstein Monofilament), physical function (Lower extremity functional scale, 10-meter walk test, timed up and go) quality of life (Norfolk Quality of life-Diabetic neuropathy), and neurovascular blood flow analysis. Study participants will be 35-85 years old with a physician-confirmed diagnosis of moderate to severe lower extremity peripheral neuropathy and at least one symptom: numbness, tingling, burning, sharp pain, or increased sensitivity. They must score 0-60 on the Lower Extremity Functional Scale (LEFS), speak and understand English, provide written informed consent, and be willing to complete all study procedures, including intervention and follow-up visits. Participants must be able to ambulate independently with or without an assistive device. Subjects will be recruited using email and flyer through the Neuropathic Therapy Center (NTC) research interest list and through providers at Loma Linda's University (LLU) Health offices. 60 subjects will be recruited, and consent will take place at the LLU or at the Murrieta study site prior to randomization, administered by trained study staff authorized to obtain informed consent.

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

盲法说明

This study uses an open-label design with no masking; both participants and study personnel will know the assigned treatment group.

入排标准

年龄范围
35 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of peripheral neuropathy in the lower extremities by a physician
  • Lower Extremity Functional Scale (LEFS) score between 0-60 (indicating moderate to significant difficulty in lower extremity function)
  • Ability to speak and understand English
  • Ability to provide appropriate written informed consent
  • Willingness to participate in all study procedures, including the intervention and follow-up visits
  • Ability to ambulate independently with or without an assistive device

排除标准

  • Any medical condition suggesting potential decline in function over the next 6 months (e.g., ongoing chemotherapy, radiation therapy, or dialysis)
  • Active alcohol or drug misuse
  • End-stage renal failure
  • Uncontrolled hypertension
  • Severe dyslipidemia
  • Chronic liver disease
  • Autoimmune disease
  • Advanced chronic obstructive pulmonary disease (COPD)
  • Active inflammation
  • Shingles-related neuropathy
  • Presence of any lower extremity amputations or significant wounds
  • Severe chronic medical conditions requiring active treatment that could interfere with study outcomes
  • Morbid obesity
  • Concomitant use of medications or devices that may interfere with study results or are not allowed per protocol
  • Inability to comprehend or provide informed consent
  • Inability to speak or understand English
  • Pregnancy, breastfeeding, or planning pregnancy during the study period (female participants)
  • Inability or unwillingness to adhere to study procedures, including dietary guidelines or follow-up visits
  • Inability to complete all required study assessments, including follow-up appointments and questionnaires

结局指标

主要结局

Change in Pain Intensity

时间窗: Baseline (Week 0) and post-intervention (Week 4-5)

Pain intensity will be assessed using the Visual Analog Scale. Improvement will be indicated by reduced VAS scores. Unit of Measure: Millimeters on a 0-100 mm scale.

Change in Gait Speed

时间窗: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)

Gait speed will be assessed using the 10-Meter Walk Test. Improvement will be indicated by faster walk time. Seconds to complete 10 meters (converted to meters/second if applicable)

Change in Mobility and Fall Risk

时间窗: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)

Mobility and fall risk will be assessed using the Timed Up and Go (TUG) test. Improvement will be indicated by shorter completion times. Unit of Measure: Seconds.

Change in Sensory Function

时间窗: Baseline (Week 0), mid-treatment (Week 3), and post-intervention (Week 4-5)

Sensory function will be assessed using the Semmes-Weinstein Monofilament test. Improvement will be indicated by increased monofilament detection. Detection threshold in grams (monofilament response: detected/not detected)

Change in Functional Limitation

时间窗: Baseline (Week 0) and post-intervention (Week 4-5)

Functional limitation related to neuropathy will be assessed using the Lower Extremity Functional Scale. Improvement will be indicated by higher Lower Extremity Functional Scale scores. Scale score (0-80).

次要结局

  • Change in Quality of Life(Baseline (Week 0) and post-intervention (Week 4-5))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyan Sahba

Principal Invetigator

Loma Linda University

研究点 (2)

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