HealthyNCT06586086
The Effect of Anxiety on Pain-pressure Threshold in a Healthy Population
An observational study of Healthy, run by Philadelphia College of Osteopathic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers.
Who may be able to join
- Adults 18 years of age or older
- Able to read and complete the STAI-5 questionnaire as written in English
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia College of Osteopathic Medicine-Georgia Campus
Suwanee, Georgia, 30024
About this study
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.
Read the detailed description
Purpose Anxiety in general has been associated with lower (more sensitive) pain-pressure thresholds, however, to the best of the investigators knowledge, no research has attempted to differentiate state versus trait anxiety and their respective impacts on pressure sensitivity.
Trait anxiety is an individuals tendency to appraise situations as threatening, avoid anxiety provoking situations, and demonstrate high baseline physiological arousal. State anxiety is defined as; transient state of arousal subjectively experienced as anxiety; This study's objective is to differentiate the role of each anxiety subscale in systemic sensory perception changes. This data may better allow clinicians to glean accurate data about an individuals baseline symptoms as well as potentially shedding light on state-related changes in pain thresholds.
Objectives The primary objective of this study will be to elucidate the differing relationships of trait anxiety and state anxiety on pain-pressure threshold (PPT.) While other measures exist to gauge potential sensitization to sensory stimuli, PPT is often chosen for research due to the ease of administration and its ability to translate data into practice.
Study Population Target population will be healthy adults age 18+. As will be delineated further in this document, this study will recruit healthy adults such as to minimize potential modifications in sensory perception due to comorbidities, medication etc.
Number of Participants The study will enroll 60 participants to provide more robust statistical power
Study Design The study will be a descriptive, cross-sectional design. The study will seek to draw associations between the different anxiety subscales and the subject's pain-pressure threshold. No variables will be manipulated.
Study Duration The study participants will complete the STAI-5, a validated short version of the State-Trait Anxiety Inventory. Immediately after questionnaire administration participants will be tested for pain-pressure thresholds. Each participant session will last approximately 30 minutes. The entire study duration will be 20 weeks to allow for test administration for all participants.
Outcome Variables The outcome variable in question is pain-pressure threshold for the bilateral upper trapezius, extensor carpi radialis, Tibialis anterior, and lumbar paraspinal (L3 segment level) muscles. Each site will be tested three times, and the results will be averaged. The mean score from both sides will also subsequently be averaged to provide a single numerical outcome for each participant. PPT data for each participant will be compared with both Trait and State anxiety scores from the STAI-5 tool.
Locations/Facilities The research will be conducted entirely within the research suite in the Physical Therapy Department of the Philadelphia College of Osteopathic Medicine-Georgia Campus, Suwanee, GA.
- Conditions
- Healthy
- Keywords
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Pressure Threshold
Quantitative measurement of the amount of pressure applied at the point when the subject described the pressure as slight discomfort
Measured: 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 standardized test which measures both state and trait anxiety. Consists of two subscales, trait anxiety and state anxiety. Each section score ranges from 5 to 20, with a higher score indicating higher anxiety
Measured: A single collection session of data for each participant, lasting approximately 5 minutes. Total Data collection window is 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Oct 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Why it stopped: On hold pending challenges in scheduling for PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philadelphia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Lowe, Principal investigator, PCOM GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586086
- Sponsor's protocol ID
- 082419
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending requirements of potential publication avenues
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anxiety on Pain-pressure Threshold in a Healthy Population
- ClinicalTrials.gov ID
- NCT06586086
- Acronym / sponsor ID
- 082419
- Conditions
- Healthy
- Keywords
- Healthy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: On hold pending challenges in scheduling for PI
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Philadelphia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose Anxiety in general has been associated with lower (more sensitive) pain-pressure thresholds, however, to the best of the investigators knowledge, no research has attempted to differentiate state versus trait anxiety and their respective impacts on pressure sensitivity.
Trait anxiety is an individuals tendency to appraise situations as threatening, avoid anxiety provoking situations, and demonstrate high baseline physiological arousal. State anxiety is defined as; transient state of arousal subjectively experienced as anxiety; This study's objective is to differentiate the role of each anxiety subscale in systemic sensory perception changes. This data may better allow clinicians to glean accurate data about an individuals baseline symptoms as well as potentially shedding light on state-related changes in pain thresholds.
Objectives The primary objective of this study will be to elucidate the differing relationships of trait anxiety and state anxiety on pain-pressure threshold (PPT.) While other measures exist to gauge potential sensitization to sensory stimuli, PPT is often chosen for research due to the ease of administration and its ability to translate data into practice.
Study Population Target population will be healthy adults age 18+. As will be delineated further in this document, this study will recruit healthy adults such as to minimize potential modifications in sensory perception due to comorbidities, medication etc.
Number of Participants The study will enroll 60 participants to provide more robust statistical power
Study Design The study will be a descriptive, cross-sectional design. The study will seek to draw associations between the different anxiety subscales and the subject's pain-pressure threshold. No variables will be manipulated.
Study Duration The study participants will complete the STAI-5, a validated short version of the State-Trait Anxiety Inventory. Immediately after questionnaire administration participants will be tested for pain-pressure thresholds. Each participant session will last approximately 30 minutes. The entire study duration will be 20 weeks to allow for test administration for all participants.
Outcome Variables The outcome variable in question is pain-pressure threshold for the bilateral upper trapezius, extensor carpi radialis, Tibialis anterior, and lumbar paraspinal (L3 segment level) muscles. Each site will be tested three times, and the results will be averaged. The mean score from both sides will also subsequently be averaged to provide a single numerical outcome for each participant. PPT data for each participant will be compared with both Trait and State anxiety scores from the STAI-5 tool.
Locations/Facilities The research will be conducted entirely within the research suite in the Physical Therapy Department of the Philadelphia College of Osteopathic Medicine-Georgia Campus, Suwanee, GA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers.
Key inclusion criteria (2 listed)
- Adults 18 years of age or older
- Able to read and complete the STAI-5 questionnaire as written in English
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain-Pressure Threshold
Time frame: 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.
Quantitative measurement of the amount of pressure applied at the point when the subject described the pressure as slight discomfort
1 secondary outcome
State-Trait Anxiety questionnaire (STAI)-5 question form
Time frame: A single collection session of data for each participant, lasting approximately 5 minutes. Total Data collection window is 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Undecided. Pending requirements of potential publication avenues
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Lowe principal investigator
PCOM GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Philadelphia College of Osteopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-Pressure Threshold (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.