Screening Protocol

ConditionPain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-100
SponsorNational Center for Complementary and Integrative Health (NCCIH)

About this trial

This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood, and decision-making. Screening may include review of medical history, physical exam, vital signs, questionnaires, blood and urine tests, and optional sensory testing to better understand pain and related symptoms. The purpose is to identify and characterize healthy volunteers and people with pain who may be eligible for future NCCIH research studies. This screening study does not test a treatment and has no formal hypothesis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Stated interest in, and availability for, participating in NCCIH studies and willingness to comply with the procedures of this protocol.

At least 12 years of age

No identified acute health concerns (i.e. symptomatic uncontrolled diabetes mellitus, congestive heart failure, liver cirrhosis, ongoing cancer (excluding skin basal cell carcinoma and squamous cell carcinoma) as evidenced by screening medical history

Ability to understand and able to provide written informed consent form.

Disqualifiers

Have active medical or psychiatric health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as asymptomatic hypertensive urgency, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina. Psychiatric examples are the acute complications of psychiatric disease, such as acute mania, paranoid delusions, or having active panic attacks.

Ongoing substance uses disorder or illicit substance use

Pregnancy

Trial population

No biospecimens will be retained for future use under this protocol. Blood and urine samples, if collected, are used only for screening or clinical testing and are not stored for future research.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 2 trial groups
Group A: Healthy Volunteers
Group B: Participants With Pain

Trial outcomes

Primary outcomes

1

Screening classification of participant health and pain status

Classification of participants as healthy volunteers or participants with pain based on screening history, exam, and protocol-specified assessments.

Time frame
Up to 3 days

Secondary outcomes

1

Patient-reported pain and symptom measures

Standardized questionnaires assessing pain and related symptoms.

Time frame
Up to 3 days
2

Quantitative sensory testing measures

Standardized sensory testing assessing pain-related and sensory responses.

Time frame
Up to 3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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