NCT06611709

Brief Summary

Lateral epicondylitis significantly impacts daily activities and productivity at work, making it a condition of substantial clinical and socioeconomic importance.Despite its high prevalence, clinical significance, and impact on daily life, the optimal management of LE remains a topic of ongoing debate. This study aims to investigate the efficacy of kinesiotaping (KT) on pain intensity, functional status, and quality of life in patients with chronic lateral epicondylitis (LE). The study was conducted in the outpatient clinic for level 3 physical medicine and rehabilitation. Patients were randomized into two groups: the real kinesiotaping + home exercise group and the sham taping + home exercise group (randomized by a medical secretary outside the study). A set of widely accepted, literature-consistent primer and seconder outcomes were statistically compared to determine whether one treatment was superior to the other.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 18, 2024

Last Update Submit

September 20, 2024

Conditions

Keywords

kinesiotapinglateral epicondylitispainexercises

Outcome Measures

Primary Outcomes (2)

  • Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)

    0 (best) to 100 (worst)

    baseline, week 3, and week 7

  • VAS pain (0-10)

    0 no pain; 10 unbearable/max. pain.

    baseline, week 3, and week 7

Secondary Outcomes (4)

  • The Disabilities of the Arm, Shoulder, and Hand (DASH)

    baseline, week 3, and week 7

  • grip strength

    baseline, week 3, and week 7

  • The Short Form-36 (SF-36) quality of life index

    baseline, week 3, and week 7

  • Patient satisfaction/benefit scale (The Roles and Maudsley score)

    baseline, week 3, and week 7

Study Arms (2)

Kinesiotaping

EXPERIMENTAL

Kinesiotaping (real) + exercises

Device: Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex GoldOther: exercises

Sham-taping

SHAM COMPARATOR

Sham-taping (non-elastic medical cloth tape) + exercises

Device: sham taping (non-elastic medical cloth tape)Other: exercises

Interventions

A standard 5-cm wide KinesioⓇ Tex Gold

Kinesiotaping

home-based exercises

KinesiotapingSham-taping

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65 years
  • A pain severity of 4 or higher on the visual analog scale (VAS) during daily activities
  • A history of lateral epicondylitis symptoms lasting at least three months

You may not qualify if:

  • Communication difficulties
  • Significant psychiatric disorders
  • A history of trauma within the past six months
  • Neuromuscular conditions
  • Abnormalities of the upper limb
  • Prior upper limb surgery
  • A history of rheumatic diseases
  • Cervical disc pathology, polyneuropathy, or hand disorders (such as carpal or cubital tunnel syndrome, de Quervain tenosynovitis, osteoarthritis)
  • Receipt of any treatment for lateral epicondylitis (e.g., local injections, physical therapy, splints) within the last six month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Research and Training Hospital, Physical Medicine and Rehabilitation clinics

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

Related Publications (1)

  • Akkurt HE, Yilmaz R, Suna FS, Karpuz S, Yilmaz H. The effectiveness of kinesiotaping in treating chronic lateral epicondylitis: a randomized, sham-controlled, single-blind study. J Orthop Surg Res. 2025 Mar 14;20(1):274. doi: 10.1186/s13018-025-05658-7.

MeSH Terms

Conditions

Tennis ElbowPainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Kinesiotaping vs sham-taping
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 25, 2024

Study Start

February 1, 2024

Primary Completion

August 31, 2024

Study Completion

September 1, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations