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The Effect of Kinesio-tape and Shock Wave Therapy on Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT03904966
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Yeliz Bahar Ozdemir, Hitit University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Plantar Fascitis Calcaneus Spur Device: Kinesio tape Device: Extracorporeal shock wave therapy Not Applicable

Detailed Description:
One of the most common musculoskeletal pathologies of the foot and pain is plantar heel pain. In the studies, it was stated that the feeling of foot pain and stiffness was between 18% and 63%. The plantar fascia is the most common cause of heel pain in adult age. Due to overuse, such as standing for a long time or running, it is assumed that it occurs as a result of micro-injury on the surface of the plantar fascia. It has been reported that 10% of the general population will be encountered throughout life. Although the exact cause is not known, middle age, obesity, excessive foot pronation, pes cavus, running, pes planus and long-term standing are among the reasons that facilitate. Patients experience severe pain in the first step they take after sitting for a long time or when they get up in the morning and start to walk and the pain is triggered by the tension of the plantar fascia and overlapping weight onto the foot. A large number of conservative methods have been used in the treatment of plantar fasciitis. Anti-inflammatory agents (Non-steroidal anti-inflammatory drugs, steroid injections), physical therapy modalities (iontophoresis, ultrasound, extracorporeal shock wave therapy, electrical stimulation, cryotherapy, and whirlpool), manual therapy, stretching therapy and external support (orthosis and banding) treatment most of these methods. Orthosis and taping aim to correct poor biomechanics in the foot while most of the other treatment programs are suppressing symptoms. Extracorporeal shock wave therapy (ESWT), which is another treatment modality that is used effectively in treatment, is currently preferred in delayed and nonunion fractures, calcified tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, patellar tendinitis, and calcaneal spur. In a recent prospective study, ESWT treatment was not superior to Kinesio-taping, and both treatments were found to be similar in both pain reduction and increased functionality.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: To ensure group concealment, randomization will be done by using opaque, sealed envelopes and the assessors will be blinded to
Primary Purpose: Treatment
Official Title: The Effect of Low-dye Kinesio Taping in Addition to Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: ESWT+ Kinesiotaping
Low-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy
Device: Kinesio tape
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

Device: 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
Device: Kinesio tape
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

Device: Extracorporeal shock wave therapy
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)

ESWT
Extracorporeal shock wave therapy for 5 sessions (5-week)
Device: Extracorporeal shock wave therapy
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904966


Contacts
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Contact: Yeliz Bahar Ozdemir yelizbahar1@gmail.com
Contact: Yeliz Bahar Ozdemir +903645219523

Locations
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Turkey
Hitit University Erol Olcok Training and Research Hospital Recruiting
Çorum, Turkey, 19000
Contact: Yeliz Bahar Ozdemir       yelizbahar1@gmail.com   
Sponsors and Collaborators
Hitit University
Investigators
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Principal Investigator: Yeliz Bahar Ozdemir Hitit University Erol Olcok Training and Research Hospital

Publications:
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Responsible Party: Yeliz Bahar Ozdemir, Principal Investigator, Hitit University
ClinicalTrials.gov Identifier: NCT03904966     History of Changes
Other Study ID Numbers: 19KAEK063
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: 60 days

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

Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Heel Spur
Musculoskeletal Diseases
Foot Diseases
Exostoses
Hyperostosis
Bone Diseases