Pain Pressure Threshold in Elbow Pain

NCT06068907 | Enrolling By Invitation

• 1 other identifier: 333333
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Elbow Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pressure Pain Threshold

  3 days after the first assessment (Second assessment)

• Pain Intensity

  Baseline

• Functional Status

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with elbow pain who volunteer to participate in the study and meet the inclusion criteria will be included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tansu Birinci, PT, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: October 10, 2023
• Primary Completion: February 10, 2024
• Study Completion: February 18, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-07

Locations

TU (1)