Pain Pressure Threshold in Elbow Pain

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06068907
• Other study ID #: 333333
• Status: Enrolling by invitation
• Start date: October 10, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: June 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: June 20, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Elbow Disease
• Pain, Chronic

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold	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.	Baseline (First assessment)
Secondary	Pressure Pain Threshold	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.	3 days after the first assessment (Second assessment)
Secondary	Pain Intensity	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.	Baseline
Secondary	Functional Status	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.	Baseline