Lateral EpicondylitisNCT05771701
Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability
A study testing Pain pressure threshold measurement in people with Lateral Epicondylitis and Lateral Epicondylitis, Unspecified Elbow, run by Uskudar State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to investigate the intra- and inter-rater reliability of pain pressure threshold algometry in lateral epicondylitis patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lateral Epicondylitis, Lateral Epicondylitis, Unspecified Elbow
- What is being tested?
- Pain pressure threshold measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Rheumatoid arthritis
- Severe cognitive deficit
- Neurological deficits in the upper limb
- Inability to speak and understand English/Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam ve Sakura City Hospital
Istanbul, Başakşehir, 34000
Fatih Bağcıer, Assoc. Prof.
Fatih Bağcıer, Assoc. Prof.
About this study
This clinical trial aims to investigate the intra- and inter-rater reliability of pain pressure threshold algometry in lateral epicondylitis patients.
Read the 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.
- Being tested
- Pain pressure threshold measurement
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain pressure threshold measurementDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Lateral epicondylitis patients | Experimental | Patients that are diagnosed with lateral epicondylitis. Receives: Device: Pain pressure threshold measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability
Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Measured: 1 day
Intra-rater reliability
Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jun 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771701
- Sponsor's protocol ID
- LE1
- Status last verified
- Jun 2023
- First submitted
- 5 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data will be shared by the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability
- ClinicalTrials.gov ID
- NCT05771701
- Acronym / sponsor ID
- LE1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lateral epicondylitis patients | Experimental | Device: Pain pressure threshold measurementPatients that are diagnosed with lateral epicondylitis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain pressure threshold measurementPain 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). | Device | Lateral epicondylitis patients |
Primary outcome
Inter-rater reliability
Time frame: 1 day
Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Intra-rater reliability
Time frame: 1 day
Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared by the corresponding author upon reasonable request.
Related trials for Lateral Epicondylitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa H Temel principal investigator
Uskudar State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain pressure threshold measurement in people with Lateral Epicondylitis and Lateral Epicondylitis, Unspecified Elbow, run by Uskudar State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa H Temel, M.D. (+905342714872, mhuseyintemel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reliability (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.