Mechanisms of Neurodynamic Treatments (MONET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Median nerve fractional anisotropy as determined on diffusion weighted imaging
研究概览
简要总结
INTRODUCTION: Carpal tunnel syndrome (CTS) is a relatively common condition caused by compression of one of the main nerves at the wrist, the median nerve. Non-surgical treatments, like steroid injections and physiotherapy, are the first line of treatment for patients with carpal tunnel syndrome. The investigators have previously shown that specific physiotherapeutic exercises (neurodynamic exercises) can reduce the need for carpal tunnel surgery in some patients. Experimental studies in animal models demonstrate that these exercises have an anti-inflammatory effect and can help the nerve to regenerate. However, the exact mechanisms of action of these exercises are not well understood in patients. A better understanding of the mechanisms of action of physiotherapeutic exercises would help clinicians to better target these treatments to those patients who may benefit from them.
AIM: To investigate the mechanisms of action of 6 weeks' neurodynamic treatments on nerve function and structure as well as patient-reported outcome measures in patients with CTS compared to a positive control intervention (routine care steroid injection) and a negative control intervention (advice).
METHODS AND ANALYSIS: In this single-blind randomised mechanistic trial, patients with confirmed mild to moderate CTS (n=78) and age and gender-matched healthy controls (n=30) will be included. Patients will be randomly allocated to a 6-week neurodynamic exercise group, steroid injection, or advice group. Outcome measures will be explored at baseline (patients and controls), post-intervention (patients), and 6-month follow-up (patients). Outcomes include diffusion-weighted and anatomical MRI of the median nerve at the wrist, quantitative sensory testing, nerve conduction studies, inflammatory markers in blood and skin biopsies, and validated questionnaires for pain, function, and psychological factors. Two-way repeated measures ANCOVAs (factors time and intervention, adjusted for baseline measurements as a continuous covariate) will be performed to identify differences in MRI parameters, clinical assessment, and inflammatory markers between patients in different groups and healthy controls.
详细描述
Follow-up at 6 months will only include outcome measures from questionnaires.
Details on enrollment:
Pilot testing of healthy participants who consented to our ethics but will not be included in the study was on 13-April-2023.
- First healthy participant enrolled: 17-May-2023.
- First patient participant enrolled: 1-June-2023.
Details on amendment:
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor and the person responsible for the statistical analysis will be blinded to the participants' allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have a diagnosis of mild to moderate carpal tunnel syndrome based on a clinical assessment and confirmed with nerve conduction studies.
- •Male or Female, aged 18 years or above.
- •Patient is willing and able to give informed consent for participation in the study.
- •Healthy participants:
- •Male or female aged 18 years or above.
- •Participant is willing and able to give informed consent for participation in the study.
- •No history of hand or arm symptoms
- •No history of neck pain in the past 3 months
- •No systemic medical condition
- •No strong anticoagulant medication or altered coagulation (e.g., hemophilia) preventing skin biopsies
- •Severe anxiety or depression
- •Participants are required to be age- & sex-matched to patient participants
- •No contraindications for magnetic resonance scanning at 3T
- •Sufficient command of the English language
排除标准
- •Patients who already had surgery for their carpal tunnel syndrome (CTS) or are planning to undergo surgery in the next 6 weeks (patients with unilateral surgery who have unoperated CTS on the other hand are eligible to participate)
- •Patients who had a steroid injection for their CTS in the 6 months prior to the study enrolment or who had already more than 1 steroid injection into the study wrist.
- •Patients who have a diagnosis of severe carpal tunnel syndrome based on a clinical assessment and confirmed with electrodiagnostic testing
- •Electrodiagnostic testing revealing abnormalities other than CTS
- •Any other upper limb or neck problem for which they have sought treatment in the past 3 months
- •History of significant trauma to the upper limb or neck
- •Hypothyroidism
- •Severe anxiety or depression
- •Patient who is pregnant, lactating, or planning pregnancy during the study.
- •Patients on strong anticoagulant medication or altered coagulation preventing skin biopsies.
- •Contraindications for magnetic resonance imaging (assessed with MRI safety screening questionnaire).
- •Contraindications for steroid injections
- •Insufficient command of the English language
研究组 & 干预措施
Advice
The advice group will receive advice but no additional intervention during the 6 week intervention period (negative control group)
干预措施: Advice (Other)
Neurodynamic exercises
6-weeks home exercise programme of nerve and tendon gliding exercises
干预措施: Neurodynamic exercises (Other)
Steroid injection Steroid injection (Depomedrone 40mg)
Single steroid injection into Carpal Tunnel (positive control group)
干预措施: Steroid injection (Depomedrone 40mg) (Drug)
结局指标
主要结局
Median nerve fractional anisotropy as determined on diffusion weighted imaging
时间窗: Baseline
Fractional anisotropy will be extracted from regions-of-interest in the median nerve and compared to healthy control group
Change in median nerve fractional anisotropy as determined on diffusion weighted imaging
时间窗: From baseline to post-intervention (after 6-weeks)
Change in fractional anisotropy extracted from regions-of-interest in the median nerve at post-intervention (after 6-weeks) compared to baseline
次要结局
- Change in nerve markers on anatomical MRI(From baseline to post-intervention (after 6-weeks))
- Nerve markers on diffusion weighted imaging: water diffusivity (mm2/s)(Baseline)
- Exercise adherence to the neurodynamic home-based intervention - number of sessions(From start of intervention until end of intervention (6 weeks))
- Change in thermal detection thresholds as assessed in Quantitative Sensory testing- warm and cold detection threshold; thermal sensory limen(From baseline to post-intervention (after 6-weeks))
- Wind-up ratio as assessed in Quantitative sensory testing(Baseline)
- Vibration detection thresholds as assessed in Quantitative sensory testing(Baseline)
- Change in vibration detection thresholds as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Nerve markers on anatomical MRI(Baseline)
- Changes in median nerve MRI T2 mapping(From baseline to post-intervention (after 6-weeks))
- Thermal pain thresholds as assessed in Quantitative Sensory testing- warm and cold painful threshold(Baseline)
- Median nerve MRI magnetisation transfer ratio (MTR)(Baseline)
- Change to nerve markers on diffusion weighted imaging: water diffusivity (mm2/s)(From baseline to post-intervention (after 6-weeks))
- Median nerve MRI T2 mapping(Baseline)
- Changes in median nerve MRI magnetisation transfer ratio (MTR)(From baseline to post-intervention (after 6-weeks))
- Changes in median nerve conduction velocities from electrodiagnostic studies (m/s)(From baseline to post-intervention (after 6-weeks))
- Changes in median sensory nerve action potentials (SNAPs) and compound muscle action potentials (CMAPs): amplitudes (mV)(From baseline to post-intervention (after 6-weeks))
- Thermal detection thresholds as assessed in Quantitative Sensory testing - warm and cold detection threshold; thermal sensory limen(Baseline)
- Mechanical pain thresholds as assessed in Quantitative sensory testing(Baseline)
- Change in mechanical pain sensitivity as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Pinch strength test - maximum isometric strength(Baseline)
- Change in nerve mechanosensitivity - positive upper limb neurodynamic tests(From baseline to post-intervention (after 6-weeks))
- Symptom severity and limitations in hand function as assessed by the Boston carpal tunnel syndrome questionnaire(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Location of symptoms in a body and a hand diagram(Baseline, post-intervention (after 6 weeks))
- Functional deficits- Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Presence of neuropathic pain - pain DETECT(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Presence of psychological co-morbidities - The Depression, Anxiety, and Positive Outlook Scale (DAPOS)(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Assessment of sleep interference - Insomnia Severity Index(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Change in mechanical detection thresholds as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Change in pressure pain thresholds as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Adverse and serious adverse events(From start of intervention until end of intervention (6 weeks))
- Mechanical detection thresholds as assessed in Quantitative sensory testing(Baseline)
- Change in mechanical pain thresholds as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Mechanical pain sensitivity as assessed in Quantitative sensory testing(Baseline)
- Dynamic mechanical allodynia as assessed in Quantitative sensory testing(Baseline)
- Change in wind-up ratio as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Pressure pain thresholds as assessed in Quantitative sensory testing(Baseline)
- Change in pinch strength test - maximum isometric strength(From baseline to post-intervention (after 6-weeks))
- Neuropathic pain symptoms - Neuropathic Pain Symptom Inventory(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Change in thermal pain thresholds as assessed in Quantitative Sensory testing- warm and cold painful threshold(From baseline to post-intervention (after 6-weeks))
- Change in dynamic mechanical allodynia as assessed in Quantitative sensory testing(From baseline to post-intervention (after 6-weeks))
- Nerve mechanosensitivity- upper limb neurodynamic test (median nerve)(Baseline)
- Change in nerve mechanosensitivity- upper limb neurodynamic test (median nerve)(From baseline to post-intervention (after 6-weeks))
- Nerve mechanosensitivity - positive upper limb neurodynamic tests(Baseline)
- Presence of central sensitisation as assessed with the Central Sensitisation Inventory(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Functional deficits- Patient specific functional scale (PSFS)(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Presence of psychological co-morbidities - pain catastrophizing scale (PCS)(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Assessment of quality of life - EQ-5D-5L(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Symptom intensity levels on a Visual Analogue Scale (VAS)(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Presence of neuropathic pain - DN4(Baseline, post-intervention (after 6 weeks), 6-months follow up)
- Presence of psychological co-morbidities - short-form Pain Anxiety Symptoms Scale (PASS-20)(Baseline, post-intervention (after 6 weeks), 6-months follow up)
研究者
ProfessorAnninaSchmid
A/Prof, PhD, MMACP
University of Oxford