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NCT Number: NCT06518278

Assessing Central Aspects of Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Arthritis Chronic Low Back Pain Fibromyalgia Inflammatory Arthritis Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nottingham, Academic Rheumatology, IRIS, School of Medicine

Nottingham, NG5 1PB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Central Aspects of Pain Questionnaire

    Time frame: Baseline, 6 and 12 weeks

    Zero indicates low levels of central aspects of pain, 16 indicated high central aspects of pain

  2. Simpler pain sensitivity measures

    Time frame: Baseline

    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.

Secondary outcomes

  1. Sleep efficiency

    Time frame: Baseline

    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

  2. Hospital Anxiety and Depression Scale (HADs)

    Time frame: Baseline, 6 and 12 weeks

    0 is normal levels of anxiety or depression, 21 abnormal (case) of anxiety or depression

  3. Central Sensitization Index (CSI)

    Time frame: Baseline, 6 and 12 weeks

    scored from 0-36 higher scores indicating greater central sensitisation severity

  4. McGill pain

    Time frame: Baseline, 6 and 12 weeks

    0 (no pain) to 78 (severe pain)

  5. Self-reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)

    Time frame: Baseline, 6 and 12 weeks

    Scored 0-21. Scoring a score of 12 or more suggests pain of predominantly neuropathic origin

  6. Fibromyalgia classification criteria

    Time frame: Baseline, 6 and 12 weeks

    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

  7. Cognitive Failures Questionnaire (CFQ)

    Time frame: Baseline, 6 and 12 weeks

    Scores range from 0-100. A higher total score indicates more subjective cognitive failure.

  8. Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, 6 and 12 weeks

    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.

  9. Fatigue Impact Scale (FIS)

    Time frame: Baseline, 6 and 12 weeks

    Scores range from 0 (No problem) to 160 (extreme problems)

  10. 36-Item Short Form Survey (SF-36)

    Time frame: Baseline, 6 and 12 weeks

    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.

  11. Pittsburgh Sleep Quality (PSQI)

    Time frame: Baseline, 6 and 12 weeks

    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

  12. Laboratory pain sensitivity

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Aalborg University
  • King's College London

Registry information

Official study title

Assessing Central Nervous System Contributions to Accelerate Musculoskeletal Pain Diagnosis and Treatment

Acronym: AsCent

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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