NCT06047704

Brief Summary

The purpose of this research is to find out if different types of anxiety impact the sensation of how sensitive various muscles are to the application of pressure. This information can help researchers and healthcare providers better understand how people feel pain differently based on emotional factors This study is designed to study people who can be expected to have normal pain sensation processing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

September 14, 2023

Last Update Submit

October 12, 2023

Conditions

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

    Initial test with repeat measure at 21 days after

Secondary Outcomes (1)

  • State-Trait Anxiety questionnaire (STAI)-Short form

    Initial test with repeat measure at 21 days after

Study Arms (1)

All participants-cross sectional

All participants received the same data collection protocol. No intervention

Other: No intervention

Interventions

No intervention

All participants-cross sectional

Eligibility Criteria

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

Healthy adult volunteers without exclusion reasons present

You may qualify if:

  • \) Adults 18 years of age or older 2: 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 problems (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-GA

Suwanee, Georgia, 30024, United States

Location

MeSH Terms

Conditions

PainAnxiety DisordersMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersMuscular DiseasesMusculoskeletal Diseases

Study Design

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

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

July 28, 2023

Primary Completion

October 4, 2023

Study Completion

October 4, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

No IPD data sharing plan

Locations