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

• ClinicalTrials.gov Identifier: NCT06055933
• Recruitment Status: Completed
• First Posted: September 28, 2023
• Last Update Posted: December 5, 2023
• Sponsor: Necmettin Erbakan University
• Information provided by (Responsible Party): hanife dogan, Necmettin Erbakan University

Study Description

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?

Condition or disease
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Acute Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Pain Severity and Lower Extremity Functionality in Plantar Fasciitis
• Actual Study Start Date: October 2, 2023
• Actual Primary Completion Date: October 9, 2023
• Actual Study Completion Date: December 4, 2023

Groups and Cohorts

Group/Cohort
ESWT; To the ESWT group, with the ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shock/session values was applied with a 15 mm head in a single session. Shock waves were applied directly to the most sensitive point detected in the medial of the calcaneus.
Placebo ESWT; The placebo ESWT group was given the ESWT device sound recorded from the external audio device and the application was performed without the ESWT device operating.
ESWT+KT; With ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shocks/session was applied in a single session with a 15 mm head. Shock waves will be applied directly to the most sensitive point detected in the medial calcaneus, then a tape consisting of 96% cotton and 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Volunteers with a diagnosis of plantar fasciitis and meeting inclusion criteria

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.

Contacts and Locations

Locations

Turkey

Necmettin Erbakan Üniversitesi

Konya, Turkey, 42090

Sponsors and Collaborators

Necmettin Erbakan University

Investigators

• Principal Investigator: Hanife Doğan; Necmettin Erbakan University
• Study Chair: abdulkadir dağbaşı; Necmettin Erbakan University
• Study Chair: Aynur Başaran; Karamanoğlu Mehmetbey Üniversitesi

More Information

• Responsible Party: hanife dogan, associate professor, Necmettin Erbakan University
• ClinicalTrials.gov Identifier: NCT06055933
• Other Study ID Numbers: ADagbasi001
• First Posted: September 28, 2023
• Last Update Posted: December 5, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hanife dogan, Necmettin Erbakan University:

Plantar fasciitis; extracorporeal shock wave therapy; ESWT; placebo ESWT; plantar fascia; Kinesio Taping

Additional relevant MeSH terms:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases