Assessing Central Aspects of Pain

NCT ID: NCT06518278

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2026-10-31

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.

Conditions

Osteoarthritis; Fibromyalgia; Chronic Low Back Pain; Inflammatory Arthritis

Keywords

Quantitative Sensory Testing; Temporal Summation; Pressure Pain detection Threshold; Conditioned Pain Modulation; Offset Analgesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Musculoskeletal Pain

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Nottingham, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Stephanie L Smith, PhD

Role: CONTACT

Phone: +44 115 823 1942

Email: Stephanie.Smith2@Nottingham.ac.uk

David A Walsh, PhD

Role: CONTACT

Phone: +44 115 823 1757

Email: david.walsh@nottingham.ac.uk

Facility Contacts

Stephanie L Smith, PhD

Role: primary

David A Wlash, PhD

Role: backup

Other Identifiers

Versus Arthritis

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EULAR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24030

Identifier Type: -

Identifier Source: org_study_id