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Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability

Primary Purpose

Lateral Epicondylitis, Lateral Epicondylitis, Unspecified Elbow

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pain pressure threshold measurement
Sponsored by
Uskudar State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lateral Epicondylitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be between 18 and 90 years of age Clinical diagnosis of lateral epicondylitis (point tenderness over the lateral epicondyle and exacerbation of pain with chair pick-up test and maximal hand grip) Exclusion Criteria: History of steroid injection for the treatment of lateral epicondylitis within six months History of oral steroid use for the treatment of lateral epicondylitis within six months History of elbow surgery History of elbow fracture History of elbow dislocation Cancer Rheumatoid arthritis Severe cognitive deficit Neurological deficits in the upper limb Inability to speak and understand English/Turkish.

Sites / Locations

  • Başakşehir Çam ve Sakura City HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lateral epicondylitis patients

Arm Description

Patients that are diagnosed with lateral epicondylitis.

Outcomes

Primary Outcome Measures

Inter-rater reliability
Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Intra-rater reliability
Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1

Secondary Outcome Measures

Full Information

First Posted
March 5, 2023
Last Updated
June 5, 2023
Sponsor
Uskudar State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05771701
Brief Title
Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability
Official Title
Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial aims to investigate the intra- and inter-rater reliability of pain pressure threshold algometry in lateral epicondylitis patients.
Detailed Description
Tennis elbow, also known as lateral epicondylitis (or epicondylosis) of the elbow, was first described at the end of the 19th century. The community prevalence is 1% to 3%,38 with an even sex distribution and a peak incidence between 35 and 55 years of age.16 There is consensus that the mechanism of injury involves repetitive loads at the wrist and elbow, including supination and extension of the wrist.15 People affected by tennis elbow commonly have pain over the lateral humeral epicondyle, with flexion at the elbow also usually limited by pain, especially if the wrist is pronated and extended against resistance. Assessment of reliability is a necessary first step in the validation procedures of clinical tests. The reliability of the PPT measurement is susceptible to the influence of rater behavior and judgment, such as the instructions to the participant, rate of force application, and reaction time of the rater. We opted to investigate the intra- and inter-rater reliability of PPT in persons with lateral epicondylitis with three raters, rater blinding, and a pause of ≥20 seconds between each measurement. We hypothesized that clinicians with no former experience with the procedure can master it with good reliability after a single 30-min training session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Lateral Epicondylitis, Unspecified Elbow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before starting the investigation, the raters will practice the procedure together in a 30-min training session on a person with lateral epicondylitis. The rater will stabilize the participant's elbow with one hand. The most tender spot in the joint line of each elbow identified by palpation will be assessed with PPT algometry three times with ≥20-second intervals by each rater in a single session. The rubber tip will be placed perpendicular to the skin. The participants will be instructed to give a verbal signal as soon as the sensation of pressure turns into pain, at which time the rater will immediately remove the algometer and record the score. The display of the algometer will face the floor during the testing to blind the raters and participants for the levels of force. There will only be one rater and participant present during the testing at a time. The pause between each rater will be approximately one minute, and the rater order will change randomly during the study period.
Masking
None (Open Label)
Masking Description
The raters will be unaware of each other's test results. Furthermore, the participants will not be informed of their results. Assessor and investigator will be blinded from the providers and participants.
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lateral epicondylitis patients
Arm Type
Experimental
Arm Description
Patients that are diagnosed with lateral epicondylitis.
Intervention Type
Device
Intervention Name(s)
Pain pressure threshold measurement
Intervention Description
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. PPT has no standard protocol on administration and placement. Equipment used varies with many handheld electric algometers. PPT has been used on a wide variety of patients and conditions, including musculoskeletal and neuromuscular disorders (eg, Parkinson disease, tension headaches, pelvic pain, low back pain, myofascial trigger points, sacroiliac joint pain, knee osteoarthritis, skin humidity, shoulder pain, lateral epicondylitis).
Primary Outcome Measure Information:
Title
Inter-rater reliability
Description
Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Time Frame
1 day
Title
Intra-rater reliability
Description
Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be between 18 and 90 years of age Clinical diagnosis of lateral epicondylitis (point tenderness over the lateral epicondyle and exacerbation of pain with chair pick-up test and maximal hand grip) Exclusion Criteria: History of steroid injection for the treatment of lateral epicondylitis within six months History of oral steroid use for the treatment of lateral epicondylitis within six months History of elbow surgery History of elbow fracture History of elbow dislocation Cancer Rheumatoid arthritis Severe cognitive deficit Neurological deficits in the upper limb Inability to speak and understand English/Turkish.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa H Temel, M.D.
Phone
+905342714872
Email
mhuseyintemel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Bağcıer, M.D.
Phone
+90 544 242 90 42
Email
bagcier_42@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa H Temel
Organizational Affiliation
Uskudar State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Başakşehir Çam ve Sakura City Hospital
City
Istanbul
State/Province
Başakşehir
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Bağcıer, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Fatih Bağcıer, Assoc. Prof.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared by the corresponding author upon reasonable request.
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Individual participant data will be shared by the corresponding author upon reasonable request.

Learn more about this trial

Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability

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