Plantar FascitisNCT03904966
The Effect of Kinesio-tape and Shock Wave Therapy on Plantar Fasciitis
A study testing Kinesio tape and Extracorporeal shock wave therapy in people with Plantar Fascitis and Calcaneus Spur, run by Hitit University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fascitis, Calcaneus Spur
- What is being tested?
- Kinesio tape and Extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Erol Olcok Training and Research Hospital
Çorum, 19000
About this study
Official title: 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.
Read the 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.
- Conditions
- Plantar Fascitis, Calcaneus Spur
- Being tested
- Kinesio tape, Extracorporeal shock wave therapy
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapeDevice
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 therapyDevice
Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)
| Study group | Role | What they receive |
|---|---|---|
| ESWT+ Kinesiotaping | Experimental | Low-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy Receives: Device: Kinesio tape; Device: Extracorporeal shock wave therapy |
| ESWT+Shamtaping | Sham comparator | Sham taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy Receives: Device: Kinesio tape; Device: Extracorporeal shock wave therapy |
| ESWT | Other | Extracorporeal shock wave therapy for 5 sessions (5-week) Receives: Device: Extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Pain on the plantar heel were evaluated with the visual analog scale (0-10 mm). High scores indicate increased pain.
Measured: 30 days
Secondary outcomes (2)
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).
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start8 Apr 2019
- Primary completion5 Aug 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Bahar Ozdemir, Hitit University
- Investigators
- Yeliz Bahar Ozdemir, Principal investigator, Hitit University Erol Olcok Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904966
- Sponsor's protocol ID
- 19KAEK063
- Status last verified
- May 2020
- First submitted
- 3 Apr 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 29185674Ordahan 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.
PubMed 30375530Zielinski 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.
PubMed 1110027Kuyucu 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.
PubMed 28985751Bahar-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.
PubMed 33410228
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-dye Kinesio Taping in Addition to Extracorporeal Shock Wave Therapy in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT03904966
- Acronym / sponsor ID
- 19KAEK063
- Conditions
- Plantar Fascitis, Calcaneus Spur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| ESWT+ Kinesiotaping | Experimental | Device: Kinesio tape, Device: Extracorporeal shock wave therapyLow-dye Kinesio taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy |
| ESWT+Shamtaping | Sham comparator | Device: Kinesio tape, Device: Extracorporeal shock wave therapySham taping technique 4 times in 5 weeks in addition to extracorporeal shock wave therapy |
| ESWT | Other | Device: Extracorporeal shock wave therapyExtracorporeal shock wave therapy for 5 sessions (5-week) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapeKinesio 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 | ESWT+ Kinesiotaping, ESWT+Shamtaping |
| Extracorporeal shock wave therapyExtracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week) | Device | ESWT, ESWT+ Kinesiotaping, ESWT+Shamtaping |
Primary outcome
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 secondary outcomes
Heel tenderness index
Time frame: 30 days
Foot function index
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Background: PubMed 29185674Frassanito 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.
- Background: PubMed 30375530Ordahan 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.
- Background: PubMed 1110027Zielinski 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.
- Background: PubMed 28985751Kuyucu 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.
- Derived from this study: PubMed 33410228Bahar-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeliz Bahar Ozdemir principal investigator
Hitit University Erol Olcok Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape and Extracorporeal shock wave therapy in people with Plantar Fascitis and Calcaneus Spur, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904966, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.