Clinical trial NCT06055933: Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
Official title: Acute Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Pain Severity and Lower Extremity Functionality in Plantar Fasciitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plantar Fasciitis
Keywords: Plantar fasciitis
extracorporeal shock wave therapy
ESWT
placebo ESWT
plantar fascia
Kinesio Taping
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers with a diagnosis of plantar fasciitis and meeting inclusion criteria

Brief summary: 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?

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, post treatment (at 1th week)
Secondary outcomes:
measure: Lower Extremity Functional Scale
timeFrame: baseline, post treatment (at 1th week)
Other outcomes:
measure: Plantar Fascia Elasticity Measurement
timeFrame: baseline, post treatment (at 1th week)
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan Üniversitesi
Study officials:
affiliation: Necmettin Erbakan University
name: Hanife Doğan
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: abdulkadir dağbaşı
role: STUDY_CHAIR
affiliation: Karamanoğlu Mehmetbey Üniversitesi
name: Aynur Başaran
role: STUDY_CHAIR
References: