Pain Pressure Threshold Algometry in Lateral Epicondyliti... | NCT05771701

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

NCT05771701

Sponsor

Uskudar State Hospital

Status

Unknown status

Last Update Posted

Jun 7, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lateral Epicondylitis
Lateral Epicondylitis, Unspecified Elbow

Interventions

Pain pressure threshold measurement

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Mar 5, 2023

First Submission Date that Met QC Criteria

Mar 5, 2023

First Posted Date

Mar 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2023

Last Update Posted Date

Jun 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Hüseyin Temel, Principal Investigator, Uskudar State HospitalPrincipal Investigator

Lead Sponsor

Uskudar State HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lateral epicondylitis patients	Experimental	Patients that are diagnosed with lateral epicondylitis.	Device: Pain pressure threshold measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain pressure threshold measurement	Device	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inter-rater reliability	Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1	1 day
Intra-rater reliability	Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mustafa H Temel, M.D.	Contact	+905342714872		mhuseyintemel@gmail.com
Fatih Bağcıer, M.D.	Contact	+90 544 242 90 42		bagcier_42@hotmail.com

Overall Officials

Name	Affiliation	Role
Mustafa H Temel	Uskudar State Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Başakşehir Çam ve Sakura City Hospital	Recruiting	Istanbul	Başakşehir	34000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data will be shared by the corresponding author upon reasonable request.

Types

Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

1 year

Access Criteria

Individual participant data will be shared by the corresponding author upon reasonable request.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013716	Tennis Elbow

Ancestor Terms

ID	Term
D000070639	Elbow Tendinopathy
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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 Info

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.

Who Masked

Not provided