NCT03904966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 8, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

April 3, 2019

Last Update Submit

May 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Heel tenderness index

    30 days

  • Foot function index

    30 days

Study Arms (3)

ESWT+ Kinesiotaping

EXPERIMENTAL

Low-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy

Device: Kinesio tapeDevice: Extracorporeal shock wave therapy

ESWT+Shamtaping

SHAM COMPARATOR

Sham taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy

Device: Kinesio tapeDevice: Extracorporeal shock wave therapy

ESWT

OTHER

Extracorporeal shock wave therapy for 5 sessions (5-week)

Device: Extracorporeal shock wave therapy

Interventions

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

ESWT+ KinesiotapingESWT+Shamtaping

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

ESWTESWT+ KinesiotapingESWT+Shamtaping

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital

Çorum, 19000, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 29185674BACKGROUND
  • 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.

    PMID: 30375530BACKGROUND
  • 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.

    PMID: 1110027BACKGROUND
  • 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.

    PMID: 28985751BACKGROUND
  • 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.

MeSH Terms

Conditions

Heel Spur

Interventions

Athletic TapeExtracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

ExostosesHyperostosisBone DiseasesMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentUltrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Yeliz Bahar Ozdemir

    Hitit University Erol Olcok Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To ensure group concealment, randomization will be done by using opaque, sealed envelopes and the assessors will be blinded to
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

April 8, 2019

Primary Completion

August 5, 2019

Study Completion

September 15, 2019

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
60 days

Locations