Pain Phenotyping of Rheumatic Diseases - An Observational Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-85
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

About this trial

Background:

Rheumatic diseases can affect the joints, ligaments, tendons, bones, muscles, and skin. They can also cause inflammation, damage body tissues, and change nerve signals in the brain. This can lead to ongoing pain that interferes with daily life. Researchers want to know more about how pain affects the lives of those with rheumatic diseases.

Objective:

To learn how the body and brain experience pain in people with and without rheumatic diseases.

Eligibility:

People aged 9 to 85 years with a diagnosed or suspected rheumatic disease and ongoing pain. They must be enrolled in protocols 01-AR-0227, 94-AR-0066, or 11-AR-0223. Healthy volunteers are also needed.

Design:

All participants will have an initial visit and may have up to 5 follow-up clinic visits spaced about 6 months apart. Each visit may last 3 to 4 hours. Patients with rheumatic diseases may have up to 2 more visits if they have a disease flare-up.

All participants will have these procedures at each visit:

Bedside quantitative sensory testing (B-QST): The participant's body will be touched with various probes: a cotton tip, a tuning fork, an ice-cold tuning fork, a heat probe, a device that applies pressure, and a probe with a sharp tip. These probes will not cause injury. Participants will describe how the touches feel and rate the intensity on a scale of 1 to 10.

Questionnaires: They will rate their overall health, quality of life, and any disease activity.

Research blood: Blood will be collected during the visits. Some blood will be used for how environmental factors affect our genes.

Physical exam and History review: They will provide information about their medical history and physical exam will be performed by a clinician.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion Criteria for Subjects Suspected or Diagnosed with Rheumatic Diseases

Stated willingness to comply with all study procedures and availability for the duration of the study

Aged 9-85 years

Diagnosed or suspected of having a rheumatic disease.

Disqualifiers

Treatment with investigational drug or other investigational intervention while enrolled in this study.

Any physical exam finding that precludes bedside QST.

Developmental delay or cognitive impairment that interfere with following or understanding the test instructions.

Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded.

Trial population

The study team will contact participants who are 9 years and older and are enrolled in NIH protocols 01-AR-0227, 94-AR-0066, and 11-AR-0223, because affected participants in this study must have an established or suspected rheumatologic disease and must also be co-enrolled in one of these protocols. Healthy volunteers may include family members of participants enrolled in these studies. Potential participants may also be identified through the Office of Patient Recruitment, direct outreach to local rheumatologists, internists, and university hospital clinics, or referrals from health care providers. However, these individuals must first be enrolled in one of the NIH protocols listed above before joining this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bedside quantitative sensory testing

    Device

    It involves measuring a participant's response to standardized stimuli such as light touch, vibration, heat, cold, pressure, and sharp sensation. A qualified health professional will use various tools to stimulate the participant's nerves and record their response.

Treatment groups

225 Participants
are divided into 4 treatment groups
Group A: Adult patients1 intervention
Group B: Healthy adult volunteer1 intervention
Group C: Minor healthy volunteer aged 9 and above1 intervention
Group D: Minor patients aged 9 and above1 intervention

Trial outcomes

Primary outcomes

1

Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).

Ratings of stimulus intensity and pain will be captured using a 0 (no sensation/no pain) to 10 (most intense sensation/pain imaginable) numerical rating scale.

Time frame
Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)

Secondary outcomes

1

Quality of life

Patient questionnaires will be used to characterize pain and associated symptoms in participants across 10 core pain domains (pain intensity, pain interference, physical functioning, sleep, pain catastrophizing, depression, anxiety, global satisfaction with treatment, substance use screener, and quality of life). Age-specific measures will be utilized according to best practices when necessary.

Time frame
Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: