Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
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| ClinicalTrials.gov Identifier: NCT06055933 |
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Recruitment Status :
Completed
First Posted : September 28, 2023
Last Update Posted : December 5, 2023
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| Tracking Information | ||||||||||
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| First Submitted Date | September 20, 2023 | |||||||||
| First Posted Date | September 28, 2023 | |||||||||
| Last Update Posted Date | December 5, 2023 | |||||||||
| Actual Study Start Date | October 2, 2023 | |||||||||
| Actual Primary Completion Date | October 9, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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.
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
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.
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| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | 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 | |||||||||
| 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? |
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| 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. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Probability Sample | |||||||||
| Study Population | Volunteers with a diagnosis of plantar fasciitis and meeting inclusion criteria | |||||||||
| Condition | Plantar Fasciitis | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
90 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Actual Study Completion Date | December 4, 2023 | |||||||||
| Actual Primary Completion Date | October 9, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 65 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Turkey | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT06055933 | |||||||||
| Other Study ID Numbers | ADagbasi001 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | hanife dogan, Necmettin Erbakan University | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Necmettin Erbakan University | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Necmettin Erbakan University | |||||||||
| Verification Date | December 2023 | |||||||||