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Completed

NCT Number: NCT04498533

Bracing or Kinesio Taping in The Management of Lateral Epicondylitis

Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain and sensitivity in the lateral elbow region.

The aim of the study was to find out about is there any difference between the effects of traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis. Therefore, the forearm counterforce brace, which was widely used in daily clinical practice for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping which has become increasingly popular. The study investigated and compared the effects of the two interventions (the forearm counterforce brace and kinesio tape) on pain severity, functional status and disability of patients with lateral epicondylitis.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Istanbul Haseki Training and Research Hospital

Istanbul, 34130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged between 18 and 65 years
  • presence of elbow pain lasting for less than three months

Exclusion criteria

  • history of acute trauma or fracture on forearm
  • congenital or acquired elbow deformities
  • demyelinating diseases
  • patients who had diagnosed as fibromyalgia
  • presence of skin lesion on lateral aspect of the elbow
  • presence of rheumatic disease
  • presence of systemic infection
  • presence of pregnancy
  • presence of malignancy

Treatment and study plan

forearm strap (counterforce brace)

Other

Kinesio Tape application

Other

Primary outcomes

  1. Pain Pressure Threshold

    Time frame: Baseline to 3 week (İmmediately after treatment)

    The tenderness on the lateral aspect of elbow was evaluated with pain pressure threshold measurements. An algometer device was used to measure pain pressure threshold. Pain pressure threshold measurements were performed at the baseline of the study, immediately after and one month later after treatment.

  2. Grip Strength

    Time frame: Baseline to 3 week (İmmediately after treatment)

    Affected upper limb function was evaluated with maximal hand grip strength. Grip strength was measured with a hydraulic hand dynamometer. Grip strength was evaluated at the baseline of the study, immediately after and one month later after treatment.

Secondary outcomes

  1. Patient-Rated Tennis Elbow Evaluation Questionnaire

    Time frame: 0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)

    The Turkish version of Patient-Rated Tennis Elbow Evaluation Questionnaire was used in the study. Patient-Rated Tennis Elbow Evaluation Questionnaire is a 15-item self-reported questionnaire to measure perceived pain and disability in people with tennis elbow.

    The questionnaire is composed of three subscales: pain, usual activities and specific activities. Each of the items of the Patient-Rated Tennis Elbow Evaluation Questionnaire is scored on a 0-10 scale, where 0 is 'no pain' or 'no difficulty' and 10 is 'worst ever' or 'unable to do'. The total score ranges from 0 to 100, where high scores indicate greater pain and disability.

    Patient-Rated Tennis Elbow Evaluation Questionnaire was evaluated at the baseline of the study, immediately after and one month later after treatment.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Bracing or Kinesio Taping in The Management of Lateral Epicondylitis: a Randomized Single-blinded Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Aug 4, 2020
Registry last updated
Aug 4, 2020

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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