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Enrolling by Invitation

NCT Number: NCT06068907

Pain Pressure Threshold in Elbow Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pressure Pain Threshold

    Time frame: 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 outcomes

  1. Pressure Pain Threshold

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Validity and Reliability of Pressure Pain Threshold Assessment in Patients With Elbow Pain

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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