Investigating the Role of Central Pain Hypersensitivity in Skeletal Muscle Neural Drive, in People With Knee Pain, and in People With Fibromyalgia Syndrome (Pain-Neural Drive)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
Background: pain lasting for 12 weeks or beyond, which is often referred to as chronic pain, is common for people living with musculoskeletal conditions (e.g. arthritis, low back pain and fibromyalgia). Pain is often not directly related to the degree of muscle or joint damage. Adaptations of the central nervous system (brain, spinal cord and nerves) often occur in chronic musculoskeletal conditions and can influence how we feel pain (central pain hypersensitivity). Pain can impact on muscle activity and movement. Muscle activity is also governed by nerve signals from the central nervous system (neural drive).
The goal of this cross-sectional observational study is to investigate whether chronic musculoskeletal pain is associated with altered nerve signalling (neural drive) to skeletal muscles in adults 40 years or over with chronic knee pain, fibromyalgia and healthy pain free volunteers.
The main questions it aims to answer are:-
- Is central pain hypersensitivity associated with altered nerve signalling to skeletal muscles in adults 40 years or over with chronic pain (knee pain and for fibromyalgia) as well as healthy volunteers?
- Is altered nerve signalling to skeletal muscles associated with physical function and disability?
Participants will be asked to:-
- Have sensory testing to determine how they feel pain
- Complete static leg and arm muscle contractions with electrodes on the skin to measure muscle electrical activity
- Complete questionnaires
- Perform a short set of mobility tasks including walking, rising from a chair and balancing.
详细描述
Participants will be required to attend two visits to Derby Medical School.
Screening and eligibility assessment:- Prior to booking an appointment to attend the study, potential participants will be given the opportunity to ask questions and be pre-screened for eligibility for the study.
Participation involves two study visits:- Visit 1 involves screening for eligibility, and providing informed consent. A brief history of pain condition and clinical knee assessment will be carried out. Familiarisation with the muscle testing protocol (practicing a set of muscle contractions) a questionnaire booklet will be provided at this visit. Visit 1 will last between 30 and 45 minutes.
Visit 2 is the test session. Body weight and height will be taken. Pain sensitivity testing (quantitative sensory testing) will be followed by neuromuscular testing while sitting in a specially designed chair. Isometric muscle contractions will be measured using an isometric dynamometer. One muscle will be tested in the lower legs and one muscle in the upper arms (on both sides).
Electrodes will be placed on a muscle at the front of the leg (tibialis anterior) and at the front of the upper arm (biceps brachii). A battery of isometric (static) muscle contractions will be performed following a force trace visual feedback on a monitor. To test whether experimental remote pain has an influence on neuromuscular functioning, a temporary pain stimulus will be applied to the arm via blood pressure cuff to a subjective level of 4/10 where '0' no pain and '10' worse pain or discomfort imaginable. A series of muscle contractions will be carried out during the remote discomfort stimulus lasting approximately 2 minutes. If discomfort becomes too much at any time the cuff will be removed immediately.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Knee pain group
- •History of knee pain with an intensity level of 4 out of 10 or greater (where 0 is no pain and 10 is the worst pain imaginable) for most days in the past 3 months
- •Fibromyalgia group
- •Fibromyalgia diagnosis (participant self-reporting a previous diagnosis by a clinician)
- •Pain with an intensity level of 4 out of 10 or greater (where 0 is no pain and 10 is the worst pain imaginable) for most days in the past 3 months
- •Control group
- •- Pain free individuals without known osteoarthritis
排除标准
- •Body weight of 250kg or higher
- •Pregnancy (women)
- •Inability to give consent
- •Inability to meet the requirements of clinical assessment
- •Performed strenuous physical exercise in the past 24 hours prior to testing
- •Consumed alcohol on day of testing
- •Consumed caffeine on day of testing
结局指标
主要结局
Pressure Pain Threshold
时间窗: Once at baseline
Pressure Pain Threshold as an index of central pain hypersensitivity. Pressure Pain Threshold (PPT) performed with digital algometer, applied at proximal forearm. A gradually increasing pressure is applied, and participants indicate when the sensation of pressure turns to pain. PPDT measured in Kilopascals (kPa). Three tests applied, which are then mean averaged. Lower PPT indicates greater pain sensitivity.
Temporal Summation
时间窗: Once at baseline
Temporal Summation as an index of central pain hypersensitivity. Temporal Summation (TS) assessed using a puncate stimulator (designed not to puncture the skin). Participants rate their experience of sharpness during the stimulus on a 10 cm visual analogue scale, first following one application, and second following 10 repeated applications. TS is calculated by subtracting first score from second (in cm). Higher positive scores indicate higher sensitivity.
Conditioned Pain Modulation
时间窗: Once at baseline
Conditioned Pain Modulation as an index of central pain hypersensitivity. Conditioned pain modulation (CPM) involves temporary ischaemic pain at one arm by way of blood pressure cuff. PPT simultaneously applied to opposite forearm. CPM calculated as conditioned PPT minus non-conditioned PPT in kilopascals (kPa). Lower positive or negative CPM indicates higher sensitivity.
Short Physical Performance Battery Test
时间窗: Once at baseline
A measure of physical performance of basic physical tasks, which is made up of for tasks:- Standing balance: participants are timed as to how long they can maintain standing balance unassisted without walking aids. First with feet side by side, second in semi-tandem stance, third in full tandem-stance. Points are awarded if balance is maintained for 10 seconds. Walking speed: participants are timed to walk a short distance (3 or 4 meters) at their usual walking pace. Allowed to use their usual walking aids. Points are awarded based on pre-set time scales for completing the walk. Repeated sit to stand: participants timed as to how many times they can sit to stand 5 times from an average height chair. Points awarded based on pre-set durations. Points are combined to give an overall score ranging from 0 - 12. A higher overall score = higher physical performance.
Motor Unit Firing Characteristics of skeletal muscles via High Density Surface Electromyography (HDsEMG)
时间窗: Once at baseline
Motor unit firing characteristics will be captured using HDsEMG during a range of sub-maximal skeletal muscle contractions. HDsEMG sensor will be placed on the skin over the muscles tibialis anterior and biceps brachii bilaterally to record muscle activation. Established methods will allow analysis of motor unit firing characteristics in terms of size, number, complexity, reliability and firing rate.
次要结局
- Central Aspects of Pain Questionnaire(Once at baseline)
- Neuromuscular control(Once at baseline)
- Neuromuscular functioning alongside remote pain stimulus(Once at baseline)
- Pain Intensity(Once via questionnaire prior to objective testing, however current pain level also completed on day of objective testing. Both are at baseline.)
- RAND 36 Item Survey 1.0 - Physical Performance sub-scale (SF-36 PF)(Once at baseline.)
- Health Assessment Questionnaire - Disability Index (HAQ-DI)(Once at baseline)
- Modified Fatigue Impact Scale (MFIS)(Once at baseline)
- Physical Activity Scale for the Elderly (PASE)(Once at baseline)
研究者
Stephanie Smith
Dr Stephanie Smith
University of Nottingham