Lateral EpicondylitisNCT07876778
Metabolic and Inflammatory Indices in Lateral Epicondylitis
An observational study of Lateral Epicondylitis, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether metabolic and inflammatory indices differ between patients with chronic lateral epicondylitis (tennis elbow) and individuals without the condition. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2026to 15 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults aged 30-65 years attending the Physical Medicine and Rehabilitation Outpatient Clinic at Mardin Training and Research Hospital, Türkiye. Participants will include 72 patients diagnosed with chronic lateral epicondylitis and 72 controls without lateral epicondylitis. Controls will be recruited consecutively from eligible outpatient attendees, aiming for a similar age and sex distribution without individual matching.
Who may be able to join
- Lateral Epicondylitis Group:
- Adults aged 25-65 years.
- Lateral elbow pain lasting at least three months.
- Tenderness on palpation over the lateral epicondyle.
- Reproduction of familiar lateral elbow pain during resisted wrist extension with the elbow fully extended.
- Availability of fasting glucose and triglyceride results obtained on the same day as part of routine clinical care.
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- Provision of written informed consent.
- Control Group:
- Adults aged 25-65 years.
- No history of lateral elbow pain during the preceding 12 months.
- Negative findings on lateral epicondyle palpation and resisted wrist extension testing.
- Availability of fasting glucose and triglyceride results obtained on the same day as part of routine clinical care.
- Provision of written informed consent.
Who cannot join
- Diabetes mellitus or use of glucose-lowering medications.
- Use of lipid-lowering medications.
- Systemic inflammatory or rheumatological disease.
- Active infection, malignancy, or advanced renal or hepatic disease.
- Uncontrolled thyroid disease.
- Pregnancy.
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- Use of systemic corticosteroids or immunosuppressive medications.
- Previous elbow surgery or major elbow trauma.
- Cervical radiculopathy, peripheral nerve entrapment, elbow arthritis, or another condition that could explain lateral elbow pain.
- Injection or extracorporeal shock wave therapy (ESWT) to the lateral epicondyle within the preceding three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital
Mardin, 47100
Taha Y YILDIRIM, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Metabolic and Inflammatory Indices in Lateral Epicondylitis: A Controlled Cross-Sectional Study
This study aims to investigate whether metabolic and inflammatory indices differ between patients with chronic lateral epicondylitis (tennis elbow) and individuals without the condition. It will also examine whether these indices are associated with pain severity and functional limitations in patients with lateral epicondylitis.
This observational, controlled cross-sectional study will include 144 participants aged 30-65 years: 72 patients with chronic lateral epicondylitis and 72 controls without lateral epicondylitis.
Read more
Metabolic and inflammatory indices will be calculated using laboratory test results obtained on the day of study enrollment as part of routine clinical care. These include fasting glucose, triglycerides, HDL cholesterol, and monocyte count. The main index will be the triglyceride-glucose (TyG) index. Additional indices will include the atherogenic index of plasma (AIP), monocyte-to-HDL cholesterol ratio (MHR), and triglyceride-glucose body mass index (TyG-BMI).
Pain severity and functional limitations will be assessed using the Numeric Rating Scale (NRS) and the Patient-Rated Tennis Elbow Evaluation (PRTEE) in patients with lateral epicondylitis. Demographic characteristics, smoking status, and occupational physical demands will also be recorded.
Read the detailed description
Lateral epicondylitis is a common musculoskeletal disorder characterized by lateral elbow pain and functional impairment. Although mechanical overloading is considered an important contributing factor, metabolic abnormalities and low-grade systemic inflammation may also influence tendon health.
This study will investigate the relationship between metabolic and inflammatory indices and chronic lateral epicondylitis using data obtained from routine clinical evaluations.
The primary objective is to compare the triglyceride-glucose (TyG) index between patients with chronic lateral epicondylitis and controls without the condition. The association between the TyG index and the presence of lateral epicondylitis will also be examined after adjustment for age, sex, body mass index, smoking status, and manual or physically demanding work.
Secondary objectives include comparing the atherogenic index of plasma (AIP), monocyte-to-HDL cholesterol ratio (MHR), and TyG-BMI between groups. Associations between these indices and patient-reported pain and functional impairment will also be investigated in the lateral epicondylitis group.
Participants will undergo a clinical assessment, and laboratory results obtained on the day of enrollment during routine clinical care will be used to calculate the metabolic and inflammatory indices. No additional laboratory tests or imaging procedures will be requested for research purposes.
The findings may contribute to a better understanding of the metabolic and inflammatory characteristics associated with chronic lateral epicondylitis. Due to the cross-sectional design, the results will be interpreted as associations rather than causal relationships.
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Triglyceride-Glucose Index, Atherogenic Index of Plasma, Monocyte-to-HDL Cholesterol Ratio, TyG-BMI, PRTEE
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Epicondylitis Group | Adults aged 30-65 years with lateral epicondylitis , diagnosed based on lateral elbow pain, tenderness over the lateral epicondyle, and pain during resisted wrist extension. Metabolic and inflammatory indices will be calculated using routine laboratory results obtained on the day of enrollment. Pain severity and functional impairment will be assessed using the NRS and PRTEE. | |
| Control Group | Adults aged 30-65 years without lateral elbow pain or clinical findings of lateral epicondylitis. Controls will be recruited from the same outpatient clinic, with an age and sex distribution similar to that of the patient group, without individual matching. Metabolic and inflammatory indices will be calculated using routine laboratory results obtained on the day of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Triglyceride-Glucose (TyG) Index Between Groups
The triglyceride-glucose (TyG) index will be calculated using fasting triglyceride and glucose levels obtained from routine laboratory tests on the day of enrollment, according to the formula: ln [(fasting triglycerides (mg/dL) × fasting glucose (mg/dL)) / 2]. The TyG index is a surrogate marker of insulin resistance. The primary outcome will be the difference in TyG index between patients with chronic lateral epicondylitis and controls without lateral epicondylitis.
Measured: Baseline
Secondary outcomes (4)
Difference in Atherogenic Index of Plasma (AIP) Between Groups
The atherogenic index of plasma (AIP) will be calculated as log10 (triglycerides / HDL cholesterol), with both concentrations expressed in mmol/L. AIP values will be compared between patients with chronic lateral epicondylitis and controls.
Measured: Baseline
Difference in Monocyte-to-HDL Cholesterol Ratio (MHR) Between Groups
The monocyte-to-HDL cholesterol ratio (MHR) will be calculated by dividing the absolute monocyte count (10⁹/L) by HDL cholesterol (mg/dL). MHR values will be compared between patients with chronic lateral epicondylitis and controls.
Measured: Baseline
Difference in Triglyceride-Glucose Body Mass Index (TyG-BMI) Between Groups
The TyG-BMI index will be calculated by multiplying the triglyceride-glucose (TyG) index by body mass index (BMI, kg/m²). TyG-BMI values will be compared between patients with chronic lateral epicondylitis and controls.
Measured: Baseline
Association of Metabolic and Inflammatory Indices With Patient-Rated Tennis Elbow Evaluation (PRTEE) Scores
Associations between TyG, AIP, MHR, and TyG-BMI indices and clinical disease burden will be evaluated in patients with chronic lateral epicondylitis using the Patient-Rated Tennis Elbow Evaluation (PRTEE). The PRTEE consists of pain and functional disability subscales, with a total score ranging from 0 to 100. Higher scores indicate greater pain and functional impairment. Associations with the PRTEE total score and its pain and function subscale scores will be examined using correlation analyses.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Taha Yasin YILDIRIM, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876778
- Sponsor's protocol ID
- MEAH-PMR-TYY5
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.
PubMed 19707766Otoshi K, Takegami M, Sekiguchi M, Onishi Y, Yamazaki S, Otani K, Shishido H, Fukuhara S, Kikuchi S, Konno S. Chronic hyperglycemia increases the risk of lateral epicondylitis: the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS). Springerplus. 2015 Aug 11;4:407. doi: 10.1186/s40064-015-1204-3. eCollection 2015.
PubMed 26266078Park HB, Gwark JY, Im JH, Na JB. Factors Associated With Lateral Epicondylitis of the Elbow. Orthop J Sports Med. 2021 May 13;9(5):23259671211007734. doi: 10.1177/23259671211007734. eCollection 2021 May.
PubMed 34036114
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Inflammatory Indices in Lateral Epicondylitis: A Controlled Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07876778
- Acronym / sponsor ID
- MEAH-PMR-TYY5
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Triglyceride-Glucose Index, Atherogenic Index of Plasma, Monocyte-to-HDL Cholesterol Ratio, TyG-BMI, PRTEE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 15 Oct 2026 (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 study aims to investigate whether metabolic and inflammatory indices differ between patients with chronic lateral epicondylitis (tennis elbow) and individuals without the condition. It will also examine whether these indices are associated with pain severity and functional limitations in patients with lateral epicondylitis.
This observational, controlled cross-sectional study will include 144 participants aged 30-65 years: 72 patients with chronic lateral epicondylitis and 72 controls without lateral epicondylitis.
Metabolic and inflammatory indices will be calculated using laboratory test results obtained on the day of study enrollment as part of routine clinical care. These include fasting glucose, triglycerides, HDL cholesterol, and monocyte count. The main index will be the triglyceride-glucose (TyG) index. Additional indices will include the atherogenic index of plasma (AIP), monocyte-to-HDL cholesterol ratio (MHR), and triglyceride-glucose body mass index (TyG-BMI).
Pain severity and functional limitations will be assessed using the Numeric Rating Scale (NRS) and the Patient-Rated Tennis Elbow Evaluation (PRTEE) in patients with lateral epicondylitis. Demographic characteristics, smoking status, and occupational physical demands will also be recorded.
Detailed description
Lateral epicondylitis is a common musculoskeletal disorder characterized by lateral elbow pain and functional impairment. Although mechanical overloading is considered an important contributing factor, metabolic abnormalities and low-grade systemic inflammation may also influence tendon health.
This study will investigate the relationship between metabolic and inflammatory indices and chronic lateral epicondylitis using data obtained from routine clinical evaluations.
The primary objective is to compare the triglyceride-glucose (TyG) index between patients with chronic lateral epicondylitis and controls without the condition. The association between the TyG index and the presence of lateral epicondylitis will also be examined after adjustment for age, sex, body mass index, smoking status, and manual or physically demanding work.
Secondary objectives include comparing the atherogenic index of plasma (AIP), monocyte-to-HDL cholesterol ratio (MHR), and TyG-BMI between groups. Associations between these indices and patient-reported pain and functional impairment will also be investigated in the lateral epicondylitis group.
Participants will undergo a clinical assessment, and laboratory results obtained on the day of enrollment during routine clinical care will be used to calculate the metabolic and inflammatory indices. No additional laboratory tests or imaging procedures will be requested for research purposes.
The findings may contribute to a better understanding of the metabolic and inflammatory characteristics associated with chronic lateral epicondylitis. Due to the cross-sectional design, the results will be interpreted as associations rather than causal relationships.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral Epicondylitis Group | – | –Adults aged 30-65 years with lateral epicondylitis , diagnosed based on lateral elbow pain, tenderness over the lateral epicondyle, and pain during resisted wrist extension. Metabolic and inflammatory indices will be calculated using routine laboratory results obtained on the day of enrollment. Pain severity and functional impairment will be assessed using the NRS and PRTEE. |
| Control Group | – | –Adults aged 30-65 years without lateral elbow pain or clinical findings of lateral epicondylitis. Controls will be recruited from the same outpatient clinic, with an age and sex distribution similar to that of the patient group, without individual matching. Metabolic and inflammatory indices will be calculated using routine laboratory results obtained on the day of enrollment. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 30-65 years attending the Physical Medicine and Rehabilitation Outpatient Clinic at Mardin Training and Research Hospital, Türkiye. Participants will include 72 patients diagnosed with chronic lateral epicondylitis and 72 controls without lateral epicondylitis. Controls will be recruited consecutively from eligible outpatient attendees, aiming for a similar age and sex distribution without individual matching.
Key inclusion criteria (13 listed)
- Lateral Epicondylitis Group:
- Adults aged 25-65 years.
- Lateral elbow pain lasting at least three months.
- Tenderness on palpation over the lateral epicondyle.
- Reproduction of familiar lateral elbow pain during resisted wrist extension with the elbow fully extended.
Key exclusion criteria (10 listed)
- Diabetes mellitus or use of glucose-lowering medications.
- Use of lipid-lowering medications.
- Systemic inflammatory or rheumatological disease.
- Active infection, malignancy, or advanced renal or hepatic disease.
- Uncontrolled thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Triglyceride-Glucose (TyG) Index Between Groups
Time frame: Baseline
The triglyceride-glucose (TyG) index will be calculated using fasting triglyceride and glucose levels obtained from routine laboratory tests on the day of enrollment, according to the formula: ln [(fasting triglycerides (mg/dL) × fasting glucose (mg/dL)) / 2]. The TyG index is a surrogate marker of insulin resistance. The primary outcome will be the difference in TyG index between patients with chronic lateral epicondylitis and controls without lateral epicondylitis.
4 secondary outcomes
Difference in Atherogenic Index of Plasma (AIP) Between Groups
Time frame: Baseline
Difference in Monocyte-to-HDL Cholesterol Ratio (MHR) Between Groups
Time frame: Baseline
Difference in Triglyceride-Glucose Body Mass Index (TyG-BMI) Between Groups
Time frame: Baseline
Association of Metabolic and Inflammatory Indices With Patient-Rated Tennis Elbow Evaluation (PRTEE) Scores
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 19707766Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.
- Background: PubMed 26266078Otoshi K, Takegami M, Sekiguchi M, Onishi Y, Yamazaki S, Otani K, Shishido H, Fukuhara S, Kikuchi S, Konno S. Chronic hyperglycemia increases the risk of lateral epicondylitis: the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS). Springerplus. 2015 Aug 11;4:407. doi: 10.1186/s40064-015-1204-3. eCollection 2015.
- Background: PubMed 34036114Park HB, Gwark JY, Im JH, Na JB. Factors Associated With Lateral Epicondylitis of the Elbow. Orthop J Sports Med. 2021 May 13;9(5):23259671211007734. doi: 10.1177/23259671211007734. eCollection 2021 May.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis, run by Mardin Artuklu University 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 13 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Y YILDIRIM, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Triglyceride-Glucose (TyG) Index Between Groups (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07876778, which also lists 3 linked publications.
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 20 Oct 2026.