Clinical trial NCT06518278: Assessing Central Aspects of Pain
Official title: Assessing Central Nervous System Contributions to Accelerate Musculoskeletal Pain Diagnosis and Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis
Fibromyalgia
Chronic Low Back Pain
Inflammatory Arthritis
Keywords: Quantitative Sensory Testing
Temporal Summation
Pressure Pain detection Threshold
Conditioned Pain Modulation
Offset Analgesia
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: King's College London
name: Aalborg University
First posted: 2024-07-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include people with musculoskeletal pain attending NHS outpatient clinics and individuals who have consented to be contacted for future research from research databases at the University of Nottingham

Brief summary: BACKGROUND: Chronic pain continues for more than 12 weeks despite medication or treatment. Chronic pain is the main symptom of muscle and joint problems, rarely explained by damage to the muscle and joints alone. Activity in the central nervous system (CNS; nerves, spinal cord, and brain) pathways governs our ability to describe pain intensity and our emotional response to pain. Musculoskeletal conditions (e.g., inflammatory arthritis, osteoarthritis, low back pain, fibromyalgia) share altered CNS pathways, acknowledged by recent classifications of 'primary' and 'nociplastic' pain. Clinically useful tools to diagnose and measure activity and reveal abnormalities in these CNS pathways are needed to improve clinical decisions and accelerate new treatment development. Laboratory pain sensitivity testing and brain imaging confirm the CNS as a primary contributor to pain. These assessments are less acceptable or unfeasible for clinical practice. Simpler clinical pain sensitivity assessments are being developed. The investigators simple Central Aspects of Pain (CAP) questionnaire detects some people with pain sensitivity and knee, rheumatoid arthritis or low back pain. Combining the CAP questionnaire reflecting emotional processing and simpler pain sensitivity assessment, combining two different dimensions should be better than either approach alone.

PURPOSE: To optimise diagnosis and measurement of CNS as the primary contribution to chronic musculoskeletal pain by using the CAP questionnaire and simpler pain sensitivity assessments to ensure timely, effective diagnosis and treatment.

OBJECTIVES: 1. Assess the ease, ability and performance of the combined CAP questionnaire and simpler pain sensitivity assessments to identify CNS as the primary contributor to chronic pain across musculoskeletal conditions.

2. Use the CAP questionnaire alone or with substitute measures of activity in CNS pathways, demographic, and clinical variables to indicate pain levels at six and twelve weeks.

3. Understand the relationship between CAP and simpler pain sensitivity assessment with laboratory pain sensitivity assessments as a tool to inform the current CNS activity contributing to pain.

4. Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or over.
* One for more of the following self-reported diagnoses: fibromyalgia, inflammatory MSK condition (e.g., rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis), low back pain, osteoarthritis.
* MSK diagnosis and pain onset more than 3 months prior to baseline
* Self-reported pain levels ≥ 3 on a 0 to 10 numerical rating scale where 0 = 'no pain' and 10 = 'worst pain imaginable' on most days in the 3 months before baseline.
* Ability to give informed consent.

Exclusion Criteria:

* Terminal/uncontrolled medical or mental health condition that would prevent participants from completing assessments or pose a significant risk to participants or staff.
* Insufficient understanding of spoken or written English to comply with the requirements of the study protocol.
* Inability to adhere to the study protocol.

Primary outcomes:
measure: Central Aspects of Pain Questionnaire
timeFrame: Baseline, 6 and 12 weeks
measure: Simpler pain sensitivity measures
timeFrame: Baseline
Secondary outcomes:
measure: Sleep efficiency
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADs)
timeFrame: Baseline, 6 and 12 weeks
measure: Central Sensitization Index (CSI)
timeFrame: Baseline, 6 and 12 weeks
measure: McGill pain
timeFrame: Baseline, 6 and 12 weeks
measure: Self-reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
timeFrame: Baseline, 6 and 12 weeks
measure: Fibromyalgia classification criteria
timeFrame: Baseline, 6 and 12 weeks
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Baseline, 6 and 12 weeks
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, 6 and 12 weeks
measure: Fatigue Impact Scale (FIS)
timeFrame: Baseline, 6 and 12 weeks
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Baseline, 6 and 12 weeks
measure: Pittsburgh Sleep Quality (PSQI)
timeFrame: Baseline, 6 and 12 weeks
measure: Laboratory pain sensitivity
timeFrame: Baseline
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham, Academic Rheumatology, IRIS, School of Medicine
Study officials:
References: