ClinicalTrials.gg
Not yet recruitingNCT07876778Updated Oct 20, 2026

Metabolic and Inflammatory Indices in Lateral Epicondylitis

An observational study in Lateral Epicondylitis, sponsored by Mardin Artuklu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Mardin Artuklu University · Observational

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
144
Ages
25 Years to 65 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Lateral Epicondylitis

Browse trials for

Keywords

  • Lateral Epicondylitis
  • Triglyceride-Glucose Index
  • Atherogenic Index of Plasma
  • Monocyte-to-HDL Cholesterol Ratio
  • TyG-BMI
  • PRTEE
03

In context

Tennis Elbow

296 studies on the registry are indexed under Tennis Elbow; 63 are open to participants now.

This study's planned enrollment of 144 is above the median of 75 across 28 observational studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Mardin Artuklu University is the lead sponsor of 32 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

**Inclusion Criteria**

**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.
  • 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.

**Exclusion Criteria (Both Groups):**

  • 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.
  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
144 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

Other outcomes

  1. Association Between Occupational Physical Demands and Lateral Epicondylitis

    Exploratory analyses will examine the associations between lateral epicondylitis status and self-reported occupational physical demands, including repetitive hand, wrist, or forearm movements; forceful gripping; heavy lifting or carrying; and vibrating tool use. Each exposure will be evaluated as a separate categorical variable.

    Time frame: Baseline

07

Study locations

1 site
  • Mardin Training and Research Hospital
    Mardin, 47100, Turkey (Türkiye)
08

References and documents

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 19707766 ↗
  • Otoshi 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 26266078 ↗
  • Park 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 ↗

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 15, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
May 15, 2027
CompletionEst.
Jul 15, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 2 updates
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: responsible party
  2. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876778
Lead sponsor
Mardin Artuklu University
Collaborators
Mardin Training and Research Hospital
Responsible party
Taha Yasin YILDIRIM (Principal Investigator, Mardin Artuklu University) — Principal investigator
First posted
Oct 15, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
May 15, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Taha Y YILDIRIM, M.D.
Contact
tyasinyildirim.ftr@gmail.com
+90 534 220 77 17
Hatice G Sümer, M.D.
Contact
gzdsmr@outlook.com
+90 532 157 72 99

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion