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

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

Study Overview

• Status: Completed
• Conditions: Pain; Musculoskeletal Pain; Anxiety; Sensitisation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • Philadelphia College of Osteopathic Medicine-GA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers without exclusion reasons present

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants-cross sectional; All participants received the same data collection protocol. No intervention	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety questionnaire (STAI)-Short 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	Initial test with repeat measure at 21 days after

Collaborators and Investigators

• Sponsor: Philadelphia College of Osteopathic Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Actual): October 4, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Anxiety Disorders; Musculoskeletal Pain
• Other Study ID Numbers: H23024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD data sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No