Assessing Central Aspects of Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Nottingham
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Musculoskeletal Pain
Trial outcomes
Primary outcomes
1
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 weeks2
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
BaselineSecondary outcomes
1
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
Baseline2
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 weeks3
Central Sensitization Index (CSI)
scored from 0-36 higher scores indicating greater central sensitisation severity
Time frame
Baseline, 6 and 12 weeks4
McGill pain
0 (no pain) to 78 (severe pain)
Time frame
Baseline, 6 and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov