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The Effect of State and Trait Anxiety on Pain-pressure Threshold

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ClinicalTrials.gov Identifier: NCT06047704
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : October 13, 2023
Sponsor:
Information provided by (Responsible Party):
Philadelphia College of Osteopathic Medicine

Study Description
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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

Condition or disease Intervention/treatment
Pain Anxiety Musculoskeletal Pain Sensitisation Other: No intervention

Detailed Description:

Pain-Pressure threshold (PPT) measurements have been used extensively in both research and clinical practice. Its use allows for somewhat more quantifiable pain assessment and has been shown useful for discriminative validity in ruling in or out various conditions. (3) Individuals with higher scores on standardized measures of anxiety have been shown to be predisposed to lower (more sensitized) PPTs. As a part of medicines developing understanding of psychosocial variables in the experience of pain this relationship is consistent with other research findings.

Trait anxiety is an individual's 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 research aims to measure the individual relationships that trait anxiety and state anxiety may have on PPTs. These findings may allow clinicians to better understand one element of the biopsychosocial model of pain.

Pain-Pressure threshold(PPT) testing is an increasingly common and accessible technique used by clinicians to gauge for potential altered sensory processing. While anxiety has been shown to impact PPT, research has not been published which aims to differentiate the roles of trait and state anxiety in modification of sensory processing. While trait anxiety is thought to be a longer-term characteristic, state anxiety is thought to be more transient and influenced by circumstances. Trait anxiety is thought to influence state anxiety but does not account for all presented state anxiety.

Research examining the potential impact of trait and state anxiety as distinct yet related constructs may allow providers to better extrapolate a patient's baseline pressure sensitivity with less unexplained variability based on potential state changes.

Subjects will begin with the completion of the STAI-5 with subscales for trait and state anxiety.

Next subjects will complete testing for pain-pressure thresholds at the bilateral upper trapezius and extensor carpi radialis muscles. Each site will be tested three times and the results averaged.

Pain pressure threshold testing will be performed in accordance with protocol parameters provided by the device manufacturer (Medoc) in conjunction with the pain-pressure threshold standardized protocol produced by the German Research Network on Neuropathic Pain (DFNS.) This device and protocol have been chosen due to high reliability and safety, with evidence to support their usefulness in research even for novice users. (6) Per the standardized instructions produced by the DFNS the subjects instructions will be as follows; "This is a test of your sensitivity to deep pressure. Now I will press this pressure gauge against your shoulder/forearm and will gradually increase the pressure. Please press the signal button provided to you as soon you would describe the pressure as 'slight discomfort.' Remember that this is not a pain tolerance test, it is a pain threshold test"

Study Design
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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of State and Trait Anxiety on Pain-pressure Threshold
Actual Study Start Date : July 28, 2023
Actual Primary Completion Date : October 4, 2023
Actual Study Completion Date : October 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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Group/Cohort Intervention/treatment
All participants-cross sectional
All participants received the same data collection protocol. No intervention
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Pain Pressure Threshold [ Time Frame: Initial test with repeat measure at 21 days after ]
    Quantitative measurement of the amount of pressure applied at the point when the subject described the pressure as slight discomfort


Secondary Outcome Measures :
  1. State-Trait Anxiety questionnaire (STAI)-Short form [ Time Frame: Initial test with repeat measure at 21 days after ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers without exclusion reasons present
Criteria

Inclusion Criteria:

1) Adults 18 years of age or older 2: Able to read and complete the STAI-5 questionnaire as written in English

Exclusion Criteria:

  1. pain lasting three months or longer, located anywhere in the body
  2. severe health problems (such as cancer, cardiac, neurologic or psychiatric/anxiety disorders),
  3. current pregnancy and/or gave birth in the last year.
  4. Subjects currently taking medication which may impact sensory processing, such as antidepressants, opioids, neuroleptics, anticonvulsive drugs or steroids.
  5. Subjects diagnosed with fibromyalgia or other conditions known to reduce muscular pain pressure thresholds, such as Lyme disease, polymyalgia, Lupus and Rheumatoid Arthritis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047704


Locations
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United States, Georgia
Philadelphia College of Osteopathic Medicine-GA
Suwanee, Georgia, United States, 30024
Sponsors and Collaborators
Philadelphia College of Osteopathic Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Philadelphia College of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT06047704    
Other Study ID Numbers: H23024
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: October 13, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD data sharing plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Anxiety Disorders
Mental Disorders
Muscular Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations