NCT06382805

Brief Summary

Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

April 20, 2024

Last Update Submit

November 26, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain Measurement

    Patients' lateral epicondylitis pain intensity will be evaluated with a visual analog scale (VAS). On the visual analog scale, the left end of a 10 cm straight line represents no pain, and the right end represents excruciating pain. The patient will be asked to mark the pain he feels on the VAS scale during the test, and then this value will be measured and recorded with the help of a ruler.

    Pain will be evaluated before treatment, immediately after treatment and 6 weeks after treatment

  • Hand grip strength

    A standard hand dynamometer (Jamar® Plus + Digital Hand Dynamometer from Patterson Medical, Sammons Preston, Bolingbrook, USA) will be used to measure grip strength. The Jamar dynamometer has high reliability and validity; therefore the device has been considered the gold standard for assessing grip strength. Grip strength evaluation will be performed with patients in a sitting position from a chair. During the test, patients will be asked to position their elbows in 90° flexion and their forearms and wrists in neutral position. The test will be repeated 3 times with one minute intervals and the average of the obtained values will be recorded.

    Hand grip strength will be evaluated before treatment, immediately after treatment and 6 weeks after treatment

  • Patient-Rated Tennis Elbow Evaluation

    Functional levels of the patients will be assessed with a Patient-Rated Tennis Elbow Evaluation questionnaire. The questionnaire consists of a total of 15 questions evaluating the functional level of patients with lateral epicondylitis in the last week. 5 questions evaluate pain and the other 10 questions evaluate functional level in various tasks. The score for each question is between 0 (best) and 10 (worst). The best score that can be obtained in the section that evaluates functionality is 0, while the worst score is 100.

    Patient-Rated Tennis Elbow Evaluation will be evaluated before treatment, immediately after treatment and 6 weeks after treatment

Secondary Outcomes (1)

  • Pain Sensitivity Measurement

    Pain Sensitivity Measurement will be evaluated before treatment, immediately after treatment and 6 weeks after treatment

Study Arms (3)

Control group

ACTIVE COMPARATOR

The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.

Other: Physiotherapy program

kinesiotaping group

ACTIVE COMPARATOR

Kinesio tape application will be applied to the kinesio tape group in addition to physiotherapy. The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.

Other: Physiotherapy programOther: Kinesio Tape

high intensity laser therapy group

ACTIVE COMPARATOR

High-intensity laser application will be applied to the high-intensity laser group in addition to physiotherapy. The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.

Other: Physiotherapy programOther: High Intensity Laser therapy

Interventions

The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. Cold-pack will be applied for 15 minutes. Continuous ultrasound will be applied on lateral epicondylitis with a 5-cm ultrasound head at a dose of 1.5W/cm2 for 5 minutes and a frequency of 1-MHZ. TENS application will be performed with the BTL 4000 combination device. TENS will be applied for 20 minutes, increasing the intensity of the current until the patient feels it. The treatment program will last for a total of two weeks, 5 days a week.

Control grouphigh intensity laser therapy groupkinesiotaping group

The longitudinal muscle technique will be applied from the origin to the insertion of the forearm extensor muscles by a researcher with a Kinesio tape application certificate. In addition, transverse kinesio tape will be applied on the elbow using the fascia correction technique. The treatment program will last for a total of two weeks, 5 days a week.

kinesiotaping group

High intensity laser applications will be performed using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area for 75 seconds at a dose of 4W 6 J/cm2 (analgesic effect) by making circular movements from the center to the outside. The remaining 5 sessions will be applied to the painful area with linear movements for 12 minutes and 30 seconds at a dose of 6W 100-150 J/cm2 (biostimulation effect). The treatment program will last for a total of two weeks, 5 days a week.

high intensity laser therapy group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients over 18 years of age.
  • Those who have pain with palpation applied to the lateral epicondyle
  • Patients with pain in resisted extension of the wrist and/or middle finger
  • Pain during static stretching applied to the wrist while the elbow is extended
  • The complaints must last at least three months
  • Not having received treatment in the last three months.

You may not qualify if:

  • Pregnant and breastfeeding women
  • History of fracture or surgery in the elbow area
  • Detection of calcific tendinitis on plain radiograph of the elbow
  • History of neurological disease
  • History of osteoporosis, malignancy, hemophilia
  • Rheumatoid arthritis and other inflammatory diseases
  • Cognitive problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman training and research hospital

Adıyaman, 02000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • abuzer akbas

    hasan kalyoncu university faculty of health science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 20, 2024

First Posted

April 24, 2024

Study Start

May 2, 2024

Primary Completion

November 11, 2024

Study Completion

November 25, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations