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Completed

NCT Number: NCT06611709

Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Konya, Selçuklu, 42060, Turkey (Türkiye)

About this study

Between February 1, 2024, and August 31, 2024, a total of 42 patients (17 females, 25 males) with chronic LE were included. Patients were randomized into either the KT or sham-controlled group. Patients were blinded to which group they were assigned to. The taping was performed by the same physician, who was trained and experienced in kinesiotaping.

Kinesiotaping and sham-taping were applied six times over three weeks. Both groups received recommendations for activity modification and a home-based stretching and strengthening exercise program. The exercise program was designed by an author who has a national book chapter on exercise for the treatment of lateral epicondylitis, taking into account patient specificity and adherence, and in accordance with the literaturExercise adherence was monitored through weekly outpatient controls (while taping) and by phone check-ins two weeks after the taping was completed.

Outcome measures were visual analog scale (VAS) pain score, Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), grip strength, Disabilities of Arm, Shoulder, and Hand (DASH), quality of life in Short Form-36 (SF-36), and The Roles and Maudsley patient satisfaction score. The subjects were assessed before treatment, at the end of treatment (week three), and four weeks after the end of treatment (week seven).The assessment parameters were also conducted by the same researcher to ensure consistency.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

sham taping (non-elastic medical cloth tape)

Device

sham taping

Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold

Device

A standard 5-cm wide KinesioⓇ Tex Gold

Exercises

Other

home-based exercises

Primary outcomes

  1. Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)

    Time frame: baseline, week 3, and week 7

    0 (best) to 100 (worst)

  2. VAS pain (0-10)

    Time frame: baseline, week 3, and week 7

    0 no pain; 10 unbearable/max. pain.

Secondary outcomes

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

    Time frame: baseline, week 3, and week 7

    0 (best condition) to 100 (worst condition)

  2. grip strength

    Time frame: baseline, week 3, and week 7

    using a Jamar® dynamometer (in kilograms)

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

    Time frame: baseline, week 3, and week 7

    0, indicating the worst health status, to 100, representing the best possible health

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

    Time frame: baseline, week 3, and week 7

    The Roles and Maudsley score was utilized to evaluate pain and activity limitations in the assessment of treatment efficacy, categorized into four levels: 1 point indicating excellent, 2 points indicating good, 3 points indicating fair, and 4 points indicating poor.

Sponsors and collaborators

Lead sponsor

Konya Beyhekim Training and Research Hospital

Other Gov

Registry information

Official study title

Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis: a Randomized, Sham-controlled, Single-blind Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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