search
Back to results

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

Primary Purpose

Plantar Fascitis, Calcaneus Spur

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape
Extracorporeal shock wave therapy
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hitit University Erol Olcok Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

ESWT+ Kinesiotaping

ESWT+Shamtaping

ESWT

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Visual analog scale
Pain on the plantar heel were evaluated with the visual analog scale (0-10 mm). High scores indicate increased pain.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
April 3, 2019
Last Updated
May 30, 2020
Sponsor
Hitit University
search

1. Study Identification

Unique Protocol Identification Number
NCT03904966
Brief Title
The Effect of Kinesio-tape and Shock Wave Therapy on Plantar Fasciitis
Official Title
The Effect of Low-dye Kinesio Taping in Addition to Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis, Calcaneus Spur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantOutcomes Assessor
Masking Description
To ensure group concealment, randomization will be done by using opaque, sealed envelopes and the assessors will be blinded to
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT+ Kinesiotaping
Arm Type
Experimental
Arm Description
Low-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy
Arm Title
ESWT+Shamtaping
Arm Type
Sham Comparator
Arm Description
Sham taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy
Arm Title
ESWT
Arm Type
Other
Arm Description
Extracorporeal shock wave therapy for 5 sessions (5-week)
Intervention Type
Device
Intervention Name(s)
Kinesio tape
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy
Intervention Description
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Pain on the plantar heel were evaluated with the visual analog scale (0-10 mm). High scores indicate increased pain.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Heel tenderness index
Description
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).
Time Frame
30 days
Title
Foot function index
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeliz Bahar Ozdemir
Organizational Affiliation
Hitit University Erol Olcok Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hitit University Erol Olcok Training and Research Hospital
City
Çorum
ZIP/Postal Code
19000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
60 days
Citations:
PubMed Identifier
29185674
Citation
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.
Results Reference
background
PubMed Identifier
30375530
Citation
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.
Results Reference
background
PubMed Identifier
1110027
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. No abstract available. Polish.
Results Reference
background
PubMed Identifier
28985751
Citation
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.
Results Reference
background
PubMed Identifier
33410228
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs