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Clinical Trials/NCT06068907
NCT06068907
Enrolling By Invitation
Not Applicable

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

Istanbul University - Cerrahpasa1 site in 1 country75 target enrollmentStarted: October 10, 2023Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Istanbul University - Cerrahpasa
Enrollment
75
Locations
1
Primary Endpoint
Pressure Pain Threshold

Overview

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.

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
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

  • Functional Status(Baseline)
  • Pressure Pain Threshold(3 days after the first assessment (Second assessment))
  • Pain Intensity(Baseline)

Investigators

Sponsor
Istanbul University - Cerrahpasa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tansu Birinci

Principal Investigator

Istanbul University - Cerrahpasa

Study Sites (1)

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