NCT06586086

Brief Summary

This study recruit individuals who are 18 years of age AND Do NOT have a history of diagnosed anxiety disorders AND Do NOT currently have any area of pain lasting 3 months or longer. The study will measure discomfort with a controlled application of pressure to different muscles and compare these measures with the individual's score on a standardized assessment of anxiety.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

August 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 29, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

August 16, 2024

Last Update Submit

July 28, 2025

Conditions

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pain-Pressure Threshold

    Quantitative measurement of the amount of pressure applied at the point when the subject described the pressure as slight discomfort

    A single collection session of data for each participant, lasting approximately 30 minutes, performed after completion of the STAI-5. Total Data collection window is 4 months.

Secondary Outcomes (1)

  • State-Trait Anxiety questionnaire (STAI)-5 question form

    A single collection session of data for each participant, lasting approximately 5 minutes. Total Data collection window is 4 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers.

You may qualify if:

  • Adults 18 years of age or older
  • Able to read and complete the STAI-5 questionnaire as written in English

You may not qualify if:

  • Pain lasting three months or longer, located anywhere in the body
  • Severe health problem (such as cancer, cardiac, neurologic or psychiatric/anxiety disorders),
  • Current pregnancy and/or gave birth in the last year.
  • Subjects currently taking medication which may impact sensory processing, such as antidepressants, opioids, neuroleptics, anticonvulsive drugs or steroids.
  • Subjects diagnosed with fibromyalgia or other conditions known to reduce muscular pain-pressure thresholds, such as Lyme disease, polymyalgia, Lupus and Rheumatoid Arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia College of Osteopathic Medicine-Georgia Campus

Suwanee, Georgia, 30024, United States

Location

Study Officials

  • Dr. Lowe

    PCOM GA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2024

First Posted

September 19, 2024

Study Start

October 29, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations