Assessing Central Aspects of Pain
NCT Number: NCT06518278
Acronym: AsCent
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Osteoarthritis|Fibromyalgia|Chronic Low Back Pain|Inflammatory Arthritis
Sponsor: University of Nottingham
Collaborators: King's College London|Aalborg University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-10
Locations: University of Nottingham, Academic Rheumatology, IRIS, School of Medicine, Nottingham, NG5 1PB, United Kingdom

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.

Primary Outcome Measures: Central Aspects of Pain Questionnaire, Zero indicates low levels of central aspects of pain, 16 indicated high central aspects of pain, Baseline, 6 and 12 weeks|Simpler pain sensitivity measures, Simpler pain sensitivity will be assessed as a combination of the point at pressure changes from a feeling of pressure to a feeling of pain or discomfort (kg), temporal summation is measured at the difference between one stimuli and ten consecutive stimuli scores from 0-10 of a Visual Analog Scale (0 = no pain or sharpness, 10 = worse pain or sharpness). Conditioned pain modulation will assess the point at which pressure changes to pain or discomfort (kg) when a conditioned stimuli is applied to the contralateral arm. The number of tender sites will be assessed by palpating 18 body sites and scored based on the number of tender sites reported. Conditioned pain modulation will also be assessed based on the number of tender sites reported with and without a conditioned stimuli to the forearm. Low scores indicate low pain sensitivity, high scores indicate high pain sensitivity., Baseline
Secondary Outcome Measures: Sleep efficiency, Time difference between total sleep time and time in bed (total sleep time/time in bed) zero is poor sleep efficiency, 1 is the best sleep efficiency, Baseline|Hospital Anxiety and Depression Scale (HADs), 0 is normal levels of anxiety or depression, 21 abnormal (case) of anxiety or depression, Baseline, 6 and 12 weeks|Central Sensitization Index (CSI), scored from 0-36 higher scores indicating greater central sensitisation severity, Baseline, 6 and 12 weeks|McGill pain, 0 (no pain) to 78 (severe pain), Baseline, 6 and 12 weeks|Self-reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS), Scored 0-21. Scoring a score of 12 or more suggests pain of predominantly neuropathic origin, Baseline, 6 and 12 weeks|Fibromyalgia classification criteria, Fibromyalgia classification criteria presence of fibromyalgia determined based on a combined score from the widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3 - 6 and SS scale score ≥9, Baseline, 6 and 12 weeks|Cognitive Failures Questionnaire (CFQ), Scores range from 0-100. A higher total score indicates more subjective cognitive failure., Baseline, 6 and 12 weeks|Health Assessment Questionnaire (HAQ), The score goes from 0 (no incapacity) to 3 (full incapacity); a score below 0.5 is considered normal whereas a score above 1.5 indicates severe disability., Baseline, 6 and 12 weeks|Fatigue Impact Scale (FIS), Scores range from 0 (No problem) to 160 (extreme problems), Baseline, 6 and 12 weeks|36-Item Short Form Survey (SF-36), Score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales., Baseline, 6 and 12 weeks|Pittsburgh Sleep Quality (PSQI), Global PSQI score, which ranges from 0 to 21. A global PSQI score over 5 indicates poor sleep relative to clinical and laboratory measures, and higher scores indicate poorer sleep quality, Baseline, 6 and 12 weeks|Laboratory pain sensitivity, Laboratory pain sensitivity will be assessed as a combination of the point at pressure changes from a feeling of pressure to a feeling of pain or discomfort (kPa), temporal summation is measured at the difference between one stimuli and ten consecutive stimuli scores from 0-10 of a Visual Analog Scale (0 = no pain or sharpness, 10 = worse pain or sharpness). Conditioned pain modulation will assess the point at which pressure changes to pain or discomfort (kPa) when a conditioned stimuli is applied to the contralateral arm. Heat pain threshold is the temperature (degrees) at which the feeling of heat changes to one of pain or discomfort. Offset analgesia is the difference in visual analog pain scores (0 = no pain) 10 = worst imaginable pain) from the temperature at time point 1 and the temperature at time point 3., Baseline