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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03904966
Other study ID # 19KAEK063
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2019
Est. completion date September 15, 2019

Study information

Verified date May 2020
Source Hitit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 15, 2019
Est. primary completion date August 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Turkey Hitit University Erol Olcok Training and Research Hospital Çorum

Sponsors (1)

Lead Sponsor Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Kuyucu E, Gülenç B, Biçer 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. — View Citation

Ordahan B, Türkoglu 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. — View Citation

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. Polish. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale Pain on the plantar heel were evaluated with the visual analog scale (0-10 mm). High scores indicate increased pain. 30 days
Secondary Heel tenderness index 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
Secondary Foot function index 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
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