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

Plain English Summary

Assessing Central Aspects of Pain is a Not Applicable clinical trial sponsored by University of Nottingham studying Osteoarthritis, Fibromyalgia, Chronic Low Back Pain, Inflammatory Arthritis. This study tests how questionnaires and simple physical tests can help understand the brain's role in chronic pain from conditions like arthritis and back pain. It is for adults aged 18 and over who have had chronic pain for at least 3 months from conditions like fibromyalgia, inflammatory arthritis, osteoarthritis, or low back pain. Participation involves completing questionnaires about your pain and emotional state, and undergoing simple pain sensitivity tests. Currently, there are no specific alternative tests that focus on assessing the central nervous system's contribution to chronic musculoskeletal pain in this way. The trial aims to enroll 250 participants.

Official 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 tw

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with fibromyalgia, inflammatory arthritis, osteoarthritis, or low back pain for over 3 months. You must also report experiencing pain at least 3 out of 10 on most days for the past 3 months and be able to understand English. You cannot join if you have a serious medical or mental health condition that could interfere with the study or pose a risk, or if you cannot follow the study's instructions. This trial is studying Osteoarthritis, Fibromyalgia, Chronic Low Back Pain, Inflammatory Arthritis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures, the Central Aspects of Pain Questionnaire and simpler pain sensitivity tests, will help doctors understand if your brain and nervous system are playing a significant role The specific primary outcome measures are: Central Aspects of Pain Questionnaire (Baseline, 6 and 12 weeks); Simpler pain sensitivity measures (Baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to improve the diagnosis and treatment of chronic musculoskeletal pain by better understanding how the brain and nervous system contribute to it, filling a gap in cu This research targets Osteoarthritis, Fibromyalgia, Chronic Low Back Pain, Inflammatory Arthritis, where improved treatment options are needed.

Investor Insight

This observational study by a university sponsor suggests a growing interest in understanding the central nervous system's role in pain, potentially paving the way for new diagnostic tools and treatme

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what the tests involve. You will need to attend appointments to fill out questionnaires and perform simple pain tests. The study will track your pain levels and well-being over a 12-week period. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 250 participants

Primary Outcomes

• Central Aspects of Pain Questionnaire (Baseline, 6 and 12 weeks)
• Simpler pain sensitivity measures (Baseline)

Secondary Outcomes

• 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)

Full 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.

Trial Locations

• University of Nottingham, Academic Rheumatology, IRIS, School of Medicine, Nottingham, Nottingham, United Kingdom

Frequently Asked Questions

Related Conditions

• Osteoarthritis
• Fibromyalgia
• Chronic Low Back Pain
• Inflammatory Arthritis
• Rheumatoid Arthritis
• Psoriatic Arthritis
• Axial Spondyloarthritis
• Musculoskeletal Pain
• Chronic Pain
• Nociplastic Pain

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