An observational study in Osteoarthritis, Fibromyalgia and Chronic Low Back Pain, sponsored by University of Nottingham. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Nottingham · Observational
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Adults aged 18 years or older self-reporting one or more of the following: Osteoarthritis, Fibromyalgia, Chronic Low Back Pain, Inflammatory Arthritis and pain of \>3/10 for most days in the past 3 months before baseline.
Central Aspects of Pain Questionnaire
Zero indicates low levels of central aspects of pain, 16 indicated high central aspects of pain
Time frame: 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.
Time frame: Baseline
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
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADs)
0 is normal levels of anxiety or depression, 21 abnormal (case) of anxiety or depression
Time frame: Baseline, 6 and 12 weeks
Central Sensitization Index (CSI)
scored from 0-36 higher scores indicating greater central sensitisation severity
Time frame: Baseline, 6 and 12 weeks
McGill pain
0 (no pain) to 78 (severe pain)
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 and 12 weeks
Cognitive Failures Questionnaire (CFQ)
Scores range from 0-100. A higher total score indicates more subjective cognitive failure.
Time frame: 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.
Time frame: Baseline, 6 and 12 weeks
Fatigue Impact Scale (FIS)
Scores range from 0 (No problem) to 160 (extreme problems)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline
Plan to share: Yes — The anonymised dataset generated from this study will be made publicly available following the conclusion of ongoing research via the Advanced Pain Discovery Platform Alleviate Data Hub
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Nottingham