OsteoarthritisAsCentNCT06518278
Assessing Central Aspects of Pain
An observational study of Osteoarthritis and Fibromyalgia, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Fibromyalgia, Chronic Low Back Pain
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham, Academic Rheumatology, IRIS, School of Medicine
Nottingham, Nottingham, NG5 1PB
About this study
Official title: Assessing Central Nervous System Contributions to Accelerate Musculoskeletal Pain Diagnosis and Treatment
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.
Read more
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.
- 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.
- 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.
- Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.
- Keywords
- Quantitative Sensory Testing, Temporal Summation, Pressure Pain detection Threshold, Conditioned Pain Modulation, Offset Analgesia
- Medical subject headings
- Osteoarthritis, Fibromyalgia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Aspects of Pain Questionnaire
Zero indicates low levels of central aspects of pain, 16 indicated high central aspects of pain
Measured: 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.
Measured: Baseline
Secondary outcomes (12)
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
Measured: Baseline
Hospital Anxiety and Depression Scale (HADs)
0 is normal levels of anxiety or depression, 21 abnormal (case) of anxiety or depression
Measured: Baseline, 6 and 12 weeks
Central Sensitization Index (CSI)
scored from 0-36 higher scores indicating greater central sensitisation severity
Measured: Baseline, 6 and 12 weeks
McGill pain
0 (no pain) to 78 (severe pain)
Measured: Baseline, 6 and 12 weeks
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
Scored 0-21. Scoring a score of 12 or more suggests pain of predominantly neuropathic origin
Measured: Baseline, 6 and 12 weeks
Fibromyalgia classification criteria
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
Measured: Baseline, 6 and 12 weeks
Cognitive Failures Questionnaire (CFQ)
Scores range from 0-100. A higher total score indicates more subjective cognitive failure.
Measured: Baseline, 6 and 12 weeks
Health Assessment Questionnaire (HAQ)
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.
Measured: Baseline, 6 and 12 weeks
Fatigue Impact Scale (FIS)
Scores range from 0 (No problem) to 160 (extreme problems)
Measured: Baseline, 6 and 12 weeks
36-Item Short Form Survey (SF-36)
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.
Measured: Baseline, 6 and 12 weeks
Pittsburgh Sleep Quality (PSQI)
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
Measured: Baseline, 6 and 12 weeks
Laboratory pain sensitivity
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start23 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Aalborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518278
- Sponsor's protocol ID
- 24030
- Other IDs
- Versus Arthritis, EULAR
- Acronym
- AsCent
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised dataset generated from this study will be made publicly available following the conclusion of ongoing research via the Advanced Pain Discovery Platform Alleviate Data Hub
Publications
Clay G, Vanhegan S, Abbott C, Pearce FA, Moffatt F, Bannister K, Graven-Nielsen T, Walsh DA, Smith SL. Assessing central nervous system contributions to accelerate musculoskeletal pain diagnosis and treatment (AsCent): protocol for a mixed-method, prospective observational study. BMJ Open. 2026 May 18;16(5):e115860. doi: 10.1136/bmjopen-2025-115860.
PubMed 42150838
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Central Nervous System Contributions to Accelerate Musculoskeletal Pain Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT06518278
- Acronym / sponsor ID
- AsCent / 24030
- Keywords
- Quantitative Sensory Testing, Temporal Summation, Pressure Pain detection Threshold, Conditioned Pain Modulation, Offset Analgesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- King's College London, Aalborg University
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
12 secondary outcomes
Sleep efficiency
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADs)
Time frame: Baseline, 6 and 12 weeks
Central Sensitization Index (CSI)
Time frame: Baseline, 6 and 12 weeks
McGill pain
Time frame: Baseline, 6 and 12 weeks
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)
Time frame: Baseline, 6 and 12 weeks
Fibromyalgia classification criteria
Time frame: Baseline, 6 and 12 weeks
Cognitive Failures Questionnaire (CFQ)
Time frame: Baseline, 6 and 12 weeks
Health Assessment Questionnaire (HAQ)
Time frame: Baseline, 6 and 12 weeks
Fatigue Impact Scale (FIS)
Time frame: Baseline, 6 and 12 weeks
36-Item Short Form Survey (SF-36)
Time frame: Baseline, 6 and 12 weeks
Pittsburgh Sleep Quality (PSQI)
Time frame: Baseline, 6 and 12 weeks
Laboratory pain sensitivity
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 42150838Clay G, Vanhegan S, Abbott C, Pearce FA, Moffatt F, Bannister K, Graven-Nielsen T, Walsh DA, Smith SL. Assessing central nervous system contributions to accelerate musculoskeletal pain diagnosis and treatment (AsCent): protocol for a mixed-method, prospective observational study. BMJ Open. 2026 May 18;16(5):e115860. doi: 10.1136/bmjopen-2025-115860.
- Individual participant dataSharing planned: Yes. The anonymised dataset generated from this study will be made publicly available following the conclusion of ongoing research via the Advanced Pain Discovery Platform Alleviate Data Hub
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Fibromyalgia, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Aspects of Pain Questionnaire (time frame: Baseline, 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06518278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.