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NCT Number: NCT06055933

Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis

Type of this study: Prospective randomized controlled study. Purpose: The aim of this study is to compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock Therapy (ESWT).

To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis who received KT application in addition to ESWT treatment.

To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving placebo application.

90 volunteers will be included in the study as ESWT (n=30), placebo ESWT (n=30), ESWT and KT (n=30) application groups. How effective is ESWT, ESWT and Kinesiotape versus placebo ESWT acutely in the treatment of plantar fasciitis?

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Necmettin Erbakan Üniversitesi

Konya, 42090, Turkey (Türkiye)

About this study

Plantar fasciitis is a common disease in athletes and the sedentary population, accompanied by pain and limitation of foot function. Hot-cold tampon application, nonsteroidal anti-inflammatory drug, heel cushion, night splint, plantar fascia and Achilles stretching exercise, kinesio taping (CT), ultrasound, and extracorporeal shock wave therapy are the methods used in the treatment of plantar fasciitis. The aim of this study is to compare the acute effect on pain level, lower extremity functionality and plantar fascia flexibility in patients with plantar fasciitis receiving ESWT, patients with plantar fasciitis receiving Kinesiotape in addition to ESWT, and patients with plantar fasciitis receiving placebo ESWT.

Age (years), height (cm) and body weight (kg) measured with an adult scale with a mechanical height measure, gender, occupation, affected side and dominant side of patients diagnosed with plantar fasciitis will be recorded.

Patients will be divided into three groups: ESWT (Group 1), ESWT and KT (Group 2), and Placebo/Sham (Group 3) application groups. ESWT (BTL-6000SWT, UK); A single session will be applied at 10 Hz frequency, 2.5 Barr energy and 2000 shocks/session.

For KT application, a tape consisting of 96% cotton, 4% lycra, water-resistant, porous and adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session and the tape will be asked to remain for a week. After the first examination of the physical therapy and rehabilitation specialist physician in the placebo/Sham group, the patient will be listened to the sound of the device through the audio device and ESWT application will be applied without the device working.

For clinical follow-up of the patients, visual pain scale (VAS) score, lower extremity functional scale score will be used before and one week after treatment, and plantar fascia flexibility will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult cases aged 18-65 years diagnosed with plantar fasciitis by a physical medicine and rehabilitation specialist,
  • Cases willing to continue the study,
  • In the anamnesis, cases with severe pain when taking the first step after waking up in the morning or after a long period of inactivity and progressive aggravation of the pain as the activity continues,
  • Cases whose consent forms were obtained by being informed about the study.

Exclusion criteria

  • Cases who have undergone foot and ankle surgery,
  • Loss or decrease of sensation in the foot and ankle region for various reasons,
  • Difficulty in communication that prevents treatment and evaluations from being carried out effectively,
  • Pregnancy,
  • Presence of local infection,
  • Having a widespread or regional tumoral disease,
  • Having circulatory disorders in the lower extremities, bleeding,
  • Anticoagulant use,
  • Application of other treatment methods such as cold/hot application, exercise, orthosis use, electrotherapy agents,
  • Cases with a history of systemic, inflammatory, neurological or vascular disease.

Treatment and study plan

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: baseline, post treatment (at 1th week)

    ). VAS, with numbers from 0 to 10 on a 10 cm horizontal line; 0 means "no pain"; It was stated to the patients that 10 represented "unbearable pain". The degree of pain was recorded numerically between 0 and 10

Secondary outcomes

  1. Lower Extremity Functional Scale

    Time frame: baseline, post treatment (at 1th week)

    Lower Extremity Functional Scale; It is a scale developed to evaluate individuals' lower extremity functions, skills and activity limitations, translated into Turkish, and its validity and reliability have been established. Scoring is made between 0-80, with higher values indicating better functional level.

Other outcomes

  1. Plantar Fascia Elasticity Measurement

    Time frame: baseline, post treatment (at 1th week)

    The person will be asked to pull his/her fingers back without bending his/her knees and keeping the heel and metatarsal heads in contact with the wall, and the distance between the thumb and the wall will be measured in cm.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Acute Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Pain Severity and Lower Extremity Functionality in Plantar Fasciitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Dec 27, 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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