NCT05670314已完成不适用
Molecular Signatures of Endocannabinoid Induced Pain Relief in Humans: Lifestyle Interventions, Systemic and Localised Changes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Change in Numerical Rate Score (NRS) for Pain
研究概览
简要总结
This is a 2x2 factorial design randomised controlled trial in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm. The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents. N= 117. 2x2 intervention with individuals per block: placebo (n=27), diet only (n=26), exercise only (n=40), diet + exercise (n=24)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomisation will be performed using an online software (sealedenvelope.com). The inulin vs placebo allocation will be double blinded. The exercise part of the intervention will not be blinded
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with any pain in or around a knee on most days for more than 3 months
- •Participant is willing and able to give informed consent for participation in the study
- •Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
- •Are taking the following medications: immunosuppressants, anticoagulants, amiodarone and/or perhexiline
- •Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
- •Pregnant or breast feeding
- •History or current psychiatric illness
- •History or current neurological condition (e.g. epilepsy)
- •Those undergoing revision, having severe hip OA, inflammatory arthropathies
- •Diagnosed non-OA cause of knee pain (e.g. rheumatoid arthritis)
- •Neuropathy or diabetes mellitus
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
结局指标
主要结局
Change in Numerical Rate Score (NRS) for Pain
时间窗: Baseline and 6 weeks
The Numerical Rate Score (NRS) will be used to assess the changes in the level of pain in response to the intervention between baseline and follow-up. Participants reported their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 the worst pain imaginable.
次要结局
- Change in Functional Outcome 30-seconds Sit-to-stand (30CST)(Baseline and 6 weeks)
- Change in Functional Outcome Timed-up and go (TUG)(Baseline and 6 weeks)
- Change in Functional Outcome Grip Strength(Baseline and 6 weeks)
- Change in Pain Sensitisation Outcome Temporal Summation (TS)(Baseline and 6 weeks)
- Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superolateral Patella Site(Baseline and 6 weeks)
- Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Superomedial Patella Site(Baseline and 6 weeks)
- Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Medial Joint Line Site(Baseline and 6 weeks)
- Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Tibialis Anterior Muscle Site(Baseline and 6 weeks)
- Changes in Pain Sensitisation Outcome Pressure Pain Detection Threshold (PPT) at the Brachioradialis Muscle Site(Baseline and 6 weeks)
- Change in Short Chain Fatty Acid Butyric Acid(Baseline and 6 weeks)
- Change in Short Chain Fatty Acid Acetic Acid(Baseline and 6 weeks)
- Change in Inflammatory Protein Interleukin-6 (IL-6) Levels(Baseline and 6 weeks)
- Change in Tumor Necrosis Factor (TNF) Inflammatory Protein Levels(Baseline and 6 weeks)
- Change in Inflammatory Protein Interferon Gamma (IFN-γ) Levels(Baseline and 6 weeks)
- Changes in Gut Microbiome (Shannon Diversity Index)(Baseline and 6 weeks)
- Change in Serum Endocannabinoid Anandamide (AEA) Levels(Baseline and 6 weeks)
- Change in Serum 2-arachidonoylglycerol (2-AG) Endocannabinoid Levels(Baseline and 6 weeks)
- Changes in Calcium Voltage-gated Channel Subunit alpha1 B Gene Expression Levels Using Transcriptomics on a Subset of Individuals(Baseline and 6 weeks)
- Changes in Solute Carrier Family 12 Member 5 Gene Expression Levels Using Transcriptomics on a Subset of Individuals(Baseline and 6 weeks)
- Changes in Sodium Voltage-gated Channel Alpha Subunit 11 Gene Expression Levels Using Transcriptomics on a Subset of Individuals(Baseline and 6 weeks)
研究者
研究点 (2)
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