- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904966
The Effect of Kinesio-tape and Shock Wave Therapy on Plantar Fasciitis
The Effect of Low-dye Kinesio Taping in Addition to Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis
Foot problems are common in society. Accordingly, loss of workforce, quality of life and mental health deterioration can be observed in employees and hardship in daily life activities, balance-walking problems and fall risk increase in older adults. The presence of athletic and sedentary populations causes a large number of patients to apply to outpatient clinics with the complaint of heel pain every year. Plantar fasciitis (plantar heel pain), although multifactorial origin, obesity, overload bearing and ankle joint motion reduction factors are thought to play an active role in the emergence of discomfort.
Foot orthoses are a common treatment used for plantar heel pain, but a period of several weeks is usually required between the diagnosis and transportation to the orthosis due to the production process. Therefore, short-term therapies such as supportive banding are used to alleviate the symptoms of this intermediate period. The low-dye taping technique is the most commonly used banding technique and has been found to be effective in randomized controlled trials. In addition, there is a rare study in the literature showing the efficacy of Kinesio taping method. Although both were found to be useful in the treatment of plantar fasciitis, no randomized controlled trial was studied in this patient population of the low-dye method with Kinesio taping. In the studies, the early period of banding therapy is mentioned and studies on relatively longer treatment response are still required. Our hypothesis is that low-dye Kinesio-banding treatment added to ESWT treatment for patients diagnosed with plantar fasciitis will be effective on foot functionality by reducing the pain of the patient both in the early and later period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Çorum, Turkey, 19000
- Hitit University Erol Olcok Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain when the plantar fascia is palpated,
- Imaging of calcaneal spur radiographically,
- Description of the first step pain, after prolonged resting or awakening in the morning
- Continue with pain despite other conservative methods (NSAI, exercise, etc.)
Exclusion Criteria:
- History of steroid injection in the heel region for the same diagnosis in the last three months,
- Rheumatic disease,
- Coagulopathy, thrombophlebitis, neoplasia, systemic inflammatory diseases,
- Foot and or lumbar surgery, symptoms of lumbar radiculopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESWT+ Kinesiotaping
Low-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy
|
Kinesio tape will be applied on the plantar heel (the most painful area) of the patients for the treatment of plantar fasciitis, in addition to the extracorporeal shock wave therapy
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis.
(5 sessions for 5-week)
|
Sham Comparator: ESWT+Shamtaping
Sham taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy
|
Kinesio tape will be applied on the plantar heel (the most painful area) of the patients for the treatment of plantar fasciitis, in addition to the extracorporeal shock wave therapy
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis.
(5 sessions for 5-week)
|
Other: ESWT
Extracorporeal shock wave therapy for 5 sessions (5-week)
|
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis.
(5 sessions for 5-week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: 30 days
|
Pain on the plantar heel were evaluated with the visual analog scale (0-10 mm).
High scores indicate increased pain.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heel tenderness index
Time Frame: 30 days
|
Evaluation of the sensitivity of the heel by the physician (Heel tenderness index: 0= no pain, 1= painful, 2= painful and winces and 3= painful, winces and withdraws).
|
30 days
|
Foot function index
Time Frame: 30 days
|
It measures the impact of foot pathology on function in terms of pain, disability and activity restriction.
The questionnaire consists of 23 self-reported items divided into 3 subscales on the basis of patient values: pain, disability and activity limitation.
|
30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Frassanito P, Cavalieri C, Maestri R, Felicetti G. Effectiveness of Extracorporeal Shock Wave Therapy and kinesio taping in calcific tendinopathy of the shoulder: a randomized controlled trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):333-340. doi: 10.23736/S1973-9087.17.04749-9. Epub 2017 Nov 29.
- Ordahan B, Turkoglu G, Karahan AY, Akkurt HE. Extracorporeal Shockwave Therapy Versus Kinesiology Taping in the Management of Plantar Fasciitis: A Randomized Clinical Trial. Arch Rheumatol. 2017 Apr 17;32(3):227-233. doi: 10.5606/ArchRheumatol.2017.6059. eCollection 2017 Sep.
- Zielinski J. [Treatment of uterine corpus cancer of the I/1 stage. I. Complex treatment of uterine corpus cancer]. Ginekol Pol. 1975 Jan;46(1):49-55. No abstract available. Polish.
- Kuyucu E, Gulenc B, Bicer H, Erdil M. Assessment of the kinesiotherapy's efficacy in male athletes with calcaneal apophysitis. J Orthop Surg Res. 2017 Oct 6;12(1):146. doi: 10.1186/s13018-017-0637-5.
- Bahar-Ozdemir Y, Atan T. Effects of adjuvant low-dye Kinesio taping, adjuvant sham taping, or extracorporeal shockwave therapy alone in plantar fasciitis: A randomised double-blind controlled trial. Int J Clin Pract. 2021 May;75(5):e13993. doi: 10.1111/ijcp.13993. Epub 2021 Jan 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19KAEK063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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