Central pain sensitivity and its effect on nerve control of muscles in people with chronic knee pain or fibromyalgia
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)
This project tests whether increased central pain sensitivity is linked to changes in the nerve signals that control muscles in adults 40+ with chronic knee pain or fibromyalgia compared with pain-free volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Derby, Derbyshire) |
| Trial ID | NCT07281651 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional observational project comparing adults with chronic knee pain, adults with fibromyalgia, and pain-free controls. Participants attend two in-person visits including a screening/consent visit and a test session with body measurements, quantitative sensory testing for pain sensitivity, and neuromuscular testing. Isometric muscle contractions are measured using an isometric dynamometer with electrodes on the tibialis anterior and biceps brachii, and a temporary remote pain stimulus (blood pressure cuff) is applied to test its effect on muscle neural drive. Data will be used to see whether central pain hypersensitivity is associated with altered neural signalling to skeletal muscles.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 years or older with chronic knee pain (pain ≥4/10 most days for the past 3 months) or clinician-diagnosed fibromyalgia with similar pain levels, as well as pain-free adults as controls.
Not a fit: People who are pregnant, have BMI >35 or weigh ≥250 kg, cannot consent or complete the testing, or who recently exercised or consumed alcohol/caffeine on the test day are excluded and would not be able to participate or benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could clarify why pain and tissue damage sometimes do not match and point to treatments that target central pain mechanisms to improve muscle function and reduce symptoms.
How similar studies have performed: Previous research shows central sensitization can change pain perception and sometimes muscle activation patterns, but directly linking central pain hypersensitivity to neural drive using detailed neuromuscular testing in these groups is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * BMI\>35 * 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
Where this trial is running
Derby, Derbyshire
- University of Nottingham Graduate Entry Medicine and Health, Royal Derby Hospital, Uttoxeter Road, Derby — Derby, Derbyshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stephanie Smith, PhD — University of Nottingham
- Study coordinator: Ben Lightowler, MSc
- Email: benjamin.lightowler@nottingham.ac.uk
- Phone: +44 (0)115 7484098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.