Study Stopped
On hold pending challenges in scheduling for PI
The Effect of Anxiety on Pain-pressure Threshold in a Healthy Population
1 other identifier
observational
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
July 31, 2025
July 1, 2025
1.6 years
August 16, 2024
July 28, 2025
Conditions
Keywords
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
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
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Lowe
PCOM GA
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