Carpal Tunnel SyndromeMONETNCT05859412
Mechanisms of Neurodynamic Treatments
A study testing Neurodynamic exercises, Steroid injection (Depomedrone 40mg) and Advice in people with Carpal Tunnel Syndrome and Neurodynamic Treatment, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Neurodynamic Treatment, Nerve Mobilisation
- What is being tested?
- Neurodynamic exercises, Steroid injection (Depomedrone 40mg) and Advice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2023to 19 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- 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.
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- 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
Who cannot join
- Patients:
- 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
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- History of significant trauma to the upper limb or neck
- Diabetes
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nuffield Department of Clinical Neurosciences, University of Oxford
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Mechanisms of Neurodynamic Treatments (MONET)
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.
Read the detailed description
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:
- Amendment SA2_BPOR on 3/Aug/2023 to expand recruitment through registries of patients
- Amendment SA3_REC on 22/Aug/2023 to add Thames Valley Primary Care Research Partnership, musculoskeletal clinics, and media advertisement to help with recruitment of participants.
- Conditions
- Carpal Tunnel Syndrome, Neurodynamic Treatment, Nerve Mobilisation, Diffusion MRI, Physiotherapy, Mechanistic Trial
- Being tested
- Neurodynamic exercises, Steroid injection (Depomedrone 40mg), Advice
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic exercisesOther
The neurodynamic exercises will consist of a home-based exercise programme performed over a period of 6 weeks. Patients will attend a single session with an investigator who will instruct them the home exercise programme consisting of nerve and tendon gliding exercises which will be adjusted with pre-specified progressions over the 6 weeks intervention period. Patients will receive a leaflet and a video link detailing these exercises.
Steroid injection (Depomedrone 40mg)Drug
Steroid injection (Depomedrone 40mg) into the carpal tunnel as per standard practice in patients with carpal tunnel syndrome
AdviceOther
Group receiving advice but no additional treatment
| Study group | Role | What they receive |
|---|---|---|
| Neurodynamic exercises | Experimental | 6-weeks home exercise programme of nerve and tendon gliding exercises Receives: Other: Neurodynamic exercises |
| Steroid injection Steroid injection (Depomedrone 40mg) | Active comparator | Single steroid injection into Carpal Tunnel (positive control group) Receives: Drug: Steroid injection (Depomedrone 40mg) |
| Advice | Other | The advice group will receive advice but no additional intervention during the 6 week intervention period (negative control group) Receives: Other: Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median nerve fractional anisotropy as determined on diffusion weighted imaging
Fractional anisotropy will be extracted from regions-of-interest in the median nerve and compared to healthy control group
Measured: Baseline
Change in median nerve fractional anisotropy as determined on diffusion weighted imaging
Change in fractional anisotropy extracted from regions-of-interest in the median nerve at post-intervention (after 6-weeks) compared to baseline
Measured: From baseline to post-intervention (after 6-weeks)
Secondary outcomes (50)
Nerve markers on diffusion weighted imaging: water diffusivity (mm2/s)
Measured at the median nerve and cervical dorsal root ganglia. mm2/s; continuous data
Measured: Baseline
Change to nerve markers on diffusion weighted imaging: water diffusivity (mm2/s)
Measured at the median nerve and cervical dorsal root ganglia. mm2/s; continuous data
Measured: From baseline to post-intervention (after 6-weeks)
Nerve markers on anatomical MRI
Measured at the median nerve and cervical dorsal root ganglia. ratio/mm2; continuous data
Measured: Baseline
Change in nerve markers on anatomical MRI
Measured at the median nerve and cervical dorsal root ganglia. ratio/mm2; continuous data
Measured: From baseline to post-intervention (after 6-weeks)
Median nerve MRI T2 mapping
ms; continuous data
Measured: Baseline
Changes in median nerve MRI T2 mapping
ms; continuous data
Measured: From baseline to post-intervention (after 6-weeks)
Median nerve MRI magnetisation transfer ratio (MTR)
ratio; continuous data
Measured: Baseline
Changes in median nerve MRI magnetisation transfer ratio (MTR)
ratio; continuous data
Measured: From baseline to post-intervention (after 6-weeks)
Changes in median nerve conduction velocities from electrodiagnostic studies (m/s)
m/s; continuous data
Measured: From baseline to post-intervention (after 6-weeks)
Changes in median sensory nerve action potentials (SNAPs) and compound muscle action potentials (CMAPs): amplitudes (mV)
mV; continuous data
Measured: 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
Thermal detection thresholds will be assessed using a thermode over the index finger (e.g., ventral aspect of the proximal phalanx of the index finger).
Data is measured in degrees celsius (point at which cold or warm is detected)
Measured: Baseline
Change in thermal detection thresholds as assessed in Quantitative Sensory testing- warm and cold detection threshold; thermal sensory limen
Thermal detection thresholds will be assessed using a thermode over the index finger (e.g., ventral aspect of the proximal phalanx of the index finger).
Data is measured in degrees celsius (point at which cold or warm is detected)
Measured: From baseline to post-intervention (after 6-weeks)
Thermal pain thresholds as assessed in Quantitative Sensory testing- warm and cold painful threshold
Pain thermal thresholds will be assessed using a thermode over the index finger (e.g., ventral aspect of the proximal phalanx of the index finger) and over the contralateral lower limb (tibial anterior).
Data is measured in degrees celsius (point at which cold or warm is initially detected as painful)
Measured: Baseline
Change in thermal pain thresholds as assessed in Quantitative Sensory testing- warm and cold painful threshold
Pain thermal thresholds will be assessed using a thermode over the index finger (e.g., ventral aspect of the proximal phalanx of the index finger) and over the contralateral lower limb (tibial anterior).
Data is measured in degrees celsius (point at which cold or warm is initially detected as painful)
Measured: From baseline to post-intervention (after 6-weeks)
Mechanical detection thresholds as assessed in Quantitative sensory testing
Mechanical detection thresholds will be assessed using a standardised set of von Frey filaments (mN) over the index finger. Geometric mean will be calculated
Measured: Baseline
Change in mechanical detection thresholds as assessed in Quantitative sensory testing
Mechanical detection thresholds will be assessed using a standardised set of von Frey filaments (mN) over the index finger. Geometric mean wil be calculated
Measured: From baseline to post-intervention (after 6-weeks)
Mechanical pain thresholds as assessed in Quantitative sensory testing
Mechanical pain thresholds will be assessed using a series of weighted pin prick stimulators (mN). They will be assessed over the index finger and over the contralateral lower limb (tibial anterior).
Measured: Baseline
Change in mechanical pain thresholds as assessed in Quantitative sensory testing
Mechanical pain thresholds will be assessed using a series of weighted pin prick stimulators (mN). They will be assessed over the index finger and over the contralateral lower limb (tibial anterior).
Measured: From baseline to post-intervention (after 6-weeks)
Mechanical pain sensitivity as assessed in Quantitative sensory testing
Mechanical pain sensitivity will be assessed using a series of weighted pin prick stimulators (mN) over the index finger. Pain rating for each stimulus on a 0-100 numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable"). Geometric mean of all numerical ratings for pinprick stimuli will be calculated
Measured: Baseline
Change in mechanical pain sensitivity as assessed in Quantitative sensory testing
Mechanical pain sensitivity will be assessed using a series of weighted pin prick stimulators (mN) over the index finger. Pain rating for each stimulus on a 0-100 numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable"). Geometric mean of all numerical ratings for pinprick stimuli will be calculated
Measured: From baseline to post-intervention (after 6-weeks)
Dynamic mechanical allodynia as assessed in Quantitative sensory testing
Pain rating for each stimulus on a 0-100 numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable"). Geometric mean (compound measure) of all numerical ratings across light touch stimulators over the index finger
Measured: Baseline
Change in dynamic mechanical allodynia as assessed in Quantitative sensory testing
Pain rating for each stimulus on a 0-100 numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable"). Geometric mean (compound measure) of all numerical ratings across light touch stimulators over the index finger
Measured: From baseline to post-intervention (after 6-weeks)
Wind-up ratio as assessed in Quantitative sensory testing
Wind-up ration will be assessed using a pin prick (mN) over the index finger (e.g., ventral aspect of the proximal phalanx of the index finger). Ratio, continous data
Measured: Baseline
Change in wind-up ratio as assessed in Quantitative sensory testing
Change in wind-up ration will be assessed using a pin prick (mN) over the index finger (e.g., ventral aspect of the proximal phalanx of the index finger). Ratio, continuous data
Measured: From baseline to post-intervention (after 6-weeks)
Vibration detection thresholds as assessed in Quantitative sensory testing
Vibration detection thresholds will be assessed using a tuning fork (64 Hz, 8/8 scale) over a bony prominence over (e.g., palmar side of the distal end of the second metacarpal)
Measured: Baseline
Change in vibration detection thresholds as assessed in Quantitative sensory testing
Change in vibration detection thresholds will be assessed using a tuning fork (64 Hz, 8/8 scale) over a bony prominence over (e.g., palmar side of the distal end of the second metacarpal)
Measured: From baseline to post-intervention (after 6-weeks)
Pressure pain thresholds as assessed in Quantitative sensory testing
Pressure pain thresholds will be assessed using an algometer (kg) on the thenar eminence and over the contralateral lower limb (tibialis anterior)
Measured: Baseline
Change in pressure pain thresholds as assessed in Quantitative sensory testing
Change in pressure pain thresholds will be assessed using an algometer (kg) on the thenar eminence and over the contralateral lower limb (tibialis anterior)
Measured: From baseline to post-intervention (after 6-weeks)
Pinch strength test - maximum isometric strength
Pinch grip dynamometry. Continuous data, kg
Measured: Baseline
Change in pinch strength test - maximum isometric strength
Pinch grip dynamometry. Continuous data, kg
Measured: From baseline to post-intervention (after 6-weeks)
Nerve mechanosensitivity- upper limb neurodynamic test (median nerve)
Evaluation of nerve mechanosensitivity in response to mechanical load (increased tension) applied to the nerve. Range of elbow extension at point of symptoms (degrees)
Measured: Baseline
Change in nerve mechanosensitivity- upper limb neurodynamic test (median nerve)
Change in nerve mechanosensitivity in response to mechanical load (increased tension) applied to the nerve. Range of elbow extension at point of symptoms (degrees)
Measured: From baseline to post-intervention (after 6-weeks)
Nerve mechanosensitivity - positive upper limb neurodynamic tests
Upper limb neurodynamic tests will be assessed to determine the presence of increased mechanosensitivity. The neurodynamic test will be graded as 'positive', when there is at least partial reproduction of symptoms plus when symptoms can be modified with structural differentiation. Otherwise, the neurodynamic test will be graded as 'negative'
Measured: Baseline
Change in nerve mechanosensitivity - positive upper limb neurodynamic tests
Upper limb neurodynamic tests will be assessed to determine the presence of increased mechanosensitivity. The neurodynamic test will be graded as 'positive', when there is at least partial reproduction of symptoms and when symptoms can be modified with structural differentiation. Otherwise, the neurodynamic test will be graded as 'negative'
Measured: From baseline to post-intervention (after 6-weeks)
Symptom severity and limitations in hand function as assessed by the Boston carpal tunnel syndrome questionnaire
Patient reported symptoms and limitations on the Boston carpal tunnel syndrome questionnaire
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Symptom intensity levels on a Visual Analogue Scale (VAS)
Patient reported average intensity of pain, paraesthesia and numbness on 10cm visual analogue scales, ranging from no symptoms to worst symptoms ever
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Location of symptoms in a body and a hand diagram
Patient reported location of symptoms in a body diagram and a hand diagram.
Measured: Baseline, post-intervention (after 6 weeks)
Presence of central sensitisation as assessed with the Central Sensitisation Inventory
Patient reported central sensitisation on the Central Sensitisation Inventory
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Functional deficits- Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Participant reported outcomes on ability to perform activities as per quick DASH questionnaire
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Functional deficits- Patient specific functional scale (PSFS)
Participant reported outcomes on the patient specific functional scale
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Presence of neuropathic pain - DN4
Patient screened for neuropathic pain using DN4
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Presence of neuropathic pain - pain DETECT
Patient screened for neuropathic pain using pain DETECT
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Neuropathic pain symptoms - Neuropathic Pain Symptom Inventory
Patient reported outcomes on neuropathic pain symptoms as assessed on Neuropathic Pain Symptom Inventory.
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Presence of psychological co-morbidities - The Depression, Anxiety, and Positive Outlook Scale (DAPOS)
Participant reported outcomes on depression and anxiety as per DAPOS
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Presence of psychological co-morbidities - short-form Pain Anxiety Symptoms Scale (PASS-20)
Participant reported outcomes on depression and anxiety as per short-form Pain Anxiety Symptoms Scale (PASS-20)
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Presence of psychological co-morbidities - pain catastrophizing scale (PCS)
Participant reported outcomes on depression and anxiety as per pain catastrophising scale (PCS)
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Assessment of quality of life - EQ-5D-5L
Participant reported outcomes on quality of life as per EQ-5D-5L questionnaire
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Assessment of sleep interference - Insomnia Severity Index
Participant reported outcomes on sleep interference with the Insomnia Severity Index.
Measured: Baseline, post-intervention (after 6 weeks), 6-months follow up
Adverse and serious adverse events
Patient self-reported adverse events
Measured: From start of intervention until end of intervention (6 weeks)
Exercise adherence to the neurodynamic home-based intervention - number of sessions
Patient self-reported number of sessions per day throughout the intervention in an exercise diary
Measured: From start of intervention until end of intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start17 May 2023
- Primary completion11 Aug 2025
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Principal investigator, ProfessorAnninaSchmid, University of Oxford
- Investigators
- Eva Sierra-Silvestre, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859412
- Sponsor's protocol ID
- 313200
- Acronym
- MONET
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPDs that underlie results in a publication.
Publications
E SS, M T, Ac T, M S, G B, Ab S. Mechanisms of neurodynamic treatments (MONET): a protocol for a mechanistic, randomised, single-blind controlled trial in patients with carpal tunnel syndrome. BMC Musculoskelet Disord. 2024 Jul 27;25(1):590. doi: 10.1186/s12891-024-07713-6.
PubMed 39068435