Assessing Central Aspects of Pain

NCT06518278 | Recruiting

• 3 other identifiers: 24030Versus ArthritisEULAR
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Inflammatory Arthritis; Osteoarthritis; Fibromyalgia; Chronic Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Sleep efficiency

  Baseline

• Hospital Anxiety and Depression Scale (HADs)

  Baseline, 6 and 12 weeks

• Central Sensitization Index (CSI)

  Baseline, 6 and 12 weeks

• McGill pain

  Baseline, 6 and 12 weeks

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

  Baseline, 6 and 12 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• King's College London: collaborator
• Aalborg University: collaborator

Study Sites (1)

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

Nottingham, Nottingham, NG5 1PB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Osteoarthritis; Fibromyalgia; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Stephanie L Smith, PhD

CONTACT

+44 115 823 1942; Stephanie.Smith2@Nottingham.ac.uk

David A Walsh, PhD

CONTACT

+44 115 823 1757; david.walsh@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 24, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It is anticipated that the IPD data will be made available 1 year after the study has completed, and key findings will be disseminated (April 2028). There is currently no end date for Alleviate Data Hub (https://alleviate.ac.uk/)
• Access Criteria: Researchers can access the Alleviate data by using the platform HDR Innovation Gateway (https://www.healthdatagateway.org/). Researchers will need to demonstrate compliance with strict data security and information governance standards to be granted access to the data. Researchers will need to make a request for this data by completing the Five Safe Data Access Request Form on the website (link above). The application form covers, safe people, safe project, safe data, safe setting and safe outputs. Once access is approved, it will be made available in a safe setting, e.g. Trusted Research Environment.

Locations

GB (1)