Pain Pressure Threshold in Elbow Pain

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Recruiting
CT.gov ID
NCT06068907
Collaborator
(none)
75
1
2
37.4

Study Details

Study Description

Brief Summary

Although validity and reliability studies have been completed in different patient groups in the literature, the validity and reliability of pressure pain threshold assessment in patients with elbow pain has not been studied. This study aims to study the validity and reliability of pressure pain threshold assessment in patients with elbow pain.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Unidimensional and multidimensional scales based on patient reporting are mostly used in pain assessment. Although determining pain severity based on patient reporting is important, the patient's physiological and psychological characteristics may make it difficult to interpret the responses. Therefore, objective measurement of pain is very valuable in assessing health status. Another approach to assessing variation in pain perception is to define pressure pain threshold. Although validity and reliability studies have been completed in different patient groups in the literature, the validity and reliability of pressure pain threshold assessment in patients with elbow pain has not been studied. This study aims to study the validity and reliability of pressure pain threshold assessment in patients with elbow pain.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Validity and Reliability of Pressure Pain Threshold Assessment in Patients With Elbow Pain
    Anticipated Study Start Date :
    Oct 10, 2023
    Anticipated Primary Completion Date :
    Nov 10, 2023
    Anticipated Study Completion Date :
    Dec 10, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Pressure Pain Threshold [Baseline (First assessment)]

      A digital algometer (Commander Algometer, JTECH Medical, USA) will be used. A pressure will be applied to the pulp of the thumb of the hand, which is the control point for the patient to separate the sensation of pain and pressure. Then, a force will be applied to the same point, causing pain. In the supine position, the pressure will be applied vertically to the lateral and medial epicondyle of the humerus, olecranon fossa, radial head, lateral and medial supracondylar foss, biceps, triceps, brachialis and brachioradialis muscle body, increasing the pressure by 1 kg/cm² every three seconds until the patient feels pain. The patient will be asked to report pain as soon as he or she feels it while applying force (kg/cm²) with the device. This process will be repeated three times and there will be a 60-second break between repetitions. The same evaluation will be carried out by a second independent evaluator on the same day, 10 minutes after the first evaluation.

    Secondary Outcome Measures

    1. Pressure Pain Threshold [3 days after the first assessment (Second assessment)]

      A digital algometer (Commander Algometer, JTECH Medical, USA) will be used. A pressure will be applied to the pulp of the thumb of the hand, which is the control point for the patient to separate the sensation of pain and pressure. Then, a force will be applied to the same point, causing pain. In the supine position, the pressure will be applied vertically to the lateral and medial epicondyle of the humerus, olecranon fossa, radial head, lateral and medial supracondylar foss, biceps, triceps, brachialis and brachioradialis muscle body, increasing the pressure by 1 kg/cm² every three seconds until the patient feels pain. The patient will be asked to report pain as soon as he or she feels it while applying force (kg/cm²) with the device. This process will be repeated three times and there will be a 60-second break between repetitions.

    2. Pain Intensity [Baseline]

      Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The minimum and maximum possible scores are 0 and 10, with higher scores indicating greater pain intensity.

    3. Functional Status [Baseline]

      The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Being between the ages of 18-65 years

    • Having non-specific elbow joint pain that has been ongoing for the last 3 months

    • Having the ability to read and write Turkish

    • No vision or hearing problems

    • Must have a level of cooperation that can comply with the evaluation

    Exclusion Criteria:
    • Participated in a physiotherapy program due to elbow problem in the last 6 months

    • Presence of neurological or cognitive impairment

    • Fractures related to malignant conditions and/or elbow fractures

    • Nerve injury, heterotopic ossification or myositis ossificans

    • Having elbow arthrosis and/or elbow joint contracture

    • Nonunion, malunion and infection problems

    • Having complex regional pain syndrome

    • Having any known rheumatological, cardiovascular, respiratory or psychiatric disease

    • Having a skin disease that will affect the upper extremity evaluation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University-Cerrahpasa Istanbul Bakırkoy Turkey 34147

    Sponsors and Collaborators

    • Istanbul University - Cerrahpasa (IUC)

    Investigators

    • Principal Investigator: Tansu Birinci, PT, PhD, Istanbul University - Cerrahpasa (IUC)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tansu Birinci, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
    ClinicalTrials.gov Identifier:
    NCT06068907
    Other Study ID Numbers:
    • 333333
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 11, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2023