Plantar FasciitisNCT05153681
Comparison of Peloid Therapy and Kinesio Tape Effectiveness in Patients With Plantar Fasciitis
An observational study of Plantar Fasciitis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The Plantar Fascia (PF) is a thick, fibrous sheath located in the middle of the sole of the foot, starting from the tuber calcanei in the calcaneus and extending to the level of the middle phalanges. Plantar Fasciitis (PFs) is inflammation and thickening of the PF where it attaches to the calcaneus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Peloid Therapy
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2021to 20 Feb 2022
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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
Study population: A total of 105 patients, 35 for peloid treatment, 35 for Kinesio tape, and 35 for home exercise, were included in our study.
Who may be able to join
- Pain on the sole of the foot for six weeks or longer,
- Being between the ages of 18-65,
- Pain that is 4 or more severe according to VAS,
- Localized tenderness on palpation medial to the calcaneal tuberosity,
- Heel pain when getting out of bed in the morning or after long periods of inactivity
Who cannot join
- Having neuropathic or radicular pain,
- Acute ankle trauma,
- Having surgical intervention on the heel before,
- Receiving non-operative treatment for the heel and sole in the last 6 months (corticosteroid injection, physical therapy applications, ESWT etc.),
- Presence of rheumatological diseases such as rheumatoid arthritis, psoriatic arthritis,
- Having orthopedic deformity in the foot/ankle,
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- Those with a history of uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological..),
- Those with a history of systemic endocrine disease (DM, hyperthyroidism..),
- History of major psychiatric illness
- Bleeding disorders and those using anticoagulants
- Those with malignancy,
- Being allergic to peloid therapy,
- Pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital
Konya
Süleyman Gül, +90 0544 7376129, drsuleymangul@gmail.com
About this study
The Plantar Fascia (PF) is a thick, fibrous sheath located in the middle of the sole of the foot, starting from the tuber calcanei in the calcaneus and extending to the level of the middle phalanges. Plantar Fasciitis (PFs) is inflammation and thickening of the PF where it attaches to the calcaneus. PFs are the most common cause of heel pain. Diagnosis is made by physical examination and radiological examinations. On physical examination, there is localized tenderness medial to the calcaneal tuberosity. In the treatment of plantar fasciitis, there are many applied methods such as anti-inflammatory agents, orthostotic supports, night splints, physical therapy, corticosteroid applications, night splint use, plastering, rest, lifestyle modification, laser, taping, exercise and ESWT. Kinesio tapes, which have been used in the conservative treatment of plantar fasciitis in recent years, are elastic tapes similar to the structural properties and flexibility of human skin, without limiting joint movements. Peloidotherapy is a special balneotherapy method made with natural mud. In both domestic and international scientific studies on peloid treatment, it has been shown that pain in patients decreases, physical functions improve, quality of life increases, and the amount of painkillers use decreases. We could not find any study comparing Peloidotherapy and Kinesioband methods routinely used in the treatment of PF in the literature.
Read the detailed description
The Plantar Fascia (PF) is a thick, fibrous sheath located in the middle of the sole of the foot, starting from the tuber calcanei in the calcaneus and extending to the level of the middle phalanges. It is a tendinous aponeurosis rather than a true layer of fascia and is an important static support for the longitudinal arch of the foot. Plantar Fasciitis (PFs) is inflammation and thickening of the PF where it attaches to the calcaneus. PFs are the most common cause of heel pain. It has been reported to occur in 10% of people during their lifetime. It is more common between the ages of 40-60. Although its main etiology is not fully understood, the most common theory is; microscopic tears as a result of mechanical overstretching of the fascia followed by chronic inflammation, but histological studies lack evidence to support inflammation. Diagnosis is made by physical examination and radiological examinations (ultrasonography, radiography). On physical examination, there is localized tenderness medial to the calcaneal tuberosity. In the treatment of plantar fasciitis, there are many applied methods such as anti-inflammatory agents, orthostotic supports, night splints, physical therapy, corticosteroid applications, night splint use, plastering, rest, lifestyle modification, laser, taping, exercise and ESWT.
Kinesio tapes, which have been used in the conservative treatment of plantar fasciitis in recent years, are elastic tapes similar to the structural properties and flexibility of human skin, without limiting joint movements. Kinesio taping technique provides physiological effects on skin, fascia, muscle and joint. After applying kinesio tape, it raises the skin in the taped area, increasing the space between it and the muscles and relieving the pressure in that area. It also helps to reduce tension and sensitivity by increasing blood circulation and prevents stimulation of pain receptors.
Peloids (medical mud) are organic or inorganic substances formed as a result of geological and/or biological events. They can be found in nature as fine particles, or they are made into small, fine particles by some preliminary preparation processes. Peloidotherapy is a special balneotherapy method made with natural mud. It is used in the treatment of diseases such as degenerative joint diseases, soft tissue rheumatism, lumbardiscopathy, cervical discopathy, chronic low back and neck pain, joint pain. In both national and international scientific studies on peloid treatment, it has been shown that pain in patients decreases, physical functions improve, quality of life increases, and the amount of painkillers use decreases.
We could not find any study comparing Peloidotherapy and Kinesioband methods routinely used in the treatment of PF in the literature.
- Conditions
- Plantar Fasciitis
- Being tested
- Peloid Therapy
- Keywords
- mud therapy, balneotherapy, athletic Tape
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peloid TherapyOther
Also called Home exercise, Kinesio tape
Peloid therapy; A total of 10 sessions were applied for 30 minutes by heating the proximal part of the sole of the foot, including the heel part, at a temperature of 45 degrees. Kinesioband application: One strip is prepared as a rake with a length of about 25 cm, and the other strip is prepared as an I tape with a length of about 20 cm. The ankle is in a neutral position of 90 degrees. Lymphatic and mechanical correction technique is applied. Afterwards, the band is activated.
| Study group | Role | What they receive |
|---|---|---|
| Peloid Therapy | Peloidotherapy is a special balneotherapy method made with natural mud. In both domestic and international scientific studies on peloid treatment, it has been shown that pain in patients decreases, physical functions improve, quality of life increases, and the amount of painkillers use decreases. Receives: Other: Peloid Therapy | |
| Kinesio Tape | Kinesio tapes, which have been used in the conservative treatment of plantar fasciitis in recent years, are elastic tapes similar to the structural properties and flexibility of human skin, without limiting joint movements. | |
| Home exercise | In addition to the cold application, gastrocnemius and plantar fascia stretching and strengthening exercises were applied to patients with plantar fasciitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the efficacy of kinesio tape and peloid therapy in patients with plantar fasciitis
Measured: October 2020-February 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start20 Aug 2021
- Primary completion10 Feb 2022 (estimated)
- Study completion20 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süleyman Gül, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153681
- Sponsor's protocol ID
- KonyaMeramSH
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peloid Therapy and Kinesio Tape Effectiveness in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05153681
- Acronym / sponsor ID
- KonyaMeramSH
- Conditions
- Plantar Fasciitis
- Keywords
- mud therapy, balneotherapy, athletic Tape
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 20 Feb 2022 (estimated)
- First posted
- 10 Dec 2021 (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.
The Plantar Fascia (PF) is a thick, fibrous sheath located in the middle of the sole of the foot, starting from the tuber calcanei in the calcaneus and extending to the level of the middle phalanges. Plantar Fasciitis (PFs) is inflammation and thickening of the PF where it attaches to the calcaneus. PFs are the most common cause of heel pain. Diagnosis is made by physical examination and radiological examinations. On physical examination, there is localized tenderness medial to the calcaneal tuberosity. In the treatment of plantar fasciitis, there are many applied methods such as anti-inflammatory agents, orthostotic supports, night splints, physical therapy, corticosteroid applications, night splint use, plastering, rest, lifestyle modification, laser, taping, exercise and ESWT. Kinesio tapes, which have been used in the conservative treatment of plantar fasciitis in recent years, are elastic tapes similar to the structural properties and flexibility of human skin, without limiting joint movements. Peloidotherapy is a special balneotherapy method made with natural mud. In both domestic and international scientific studies on peloid treatment, it has been shown that pain in patients decreases, physical functions improve, quality of life increases, and the amount of painkillers use decreases. We could not find any study comparing Peloidotherapy and Kinesioband methods routinely used in the treatment of PF in the literature.
Detailed description
The Plantar Fascia (PF) is a thick, fibrous sheath located in the middle of the sole of the foot, starting from the tuber calcanei in the calcaneus and extending to the level of the middle phalanges. It is a tendinous aponeurosis rather than a true layer of fascia and is an important static support for the longitudinal arch of the foot. Plantar Fasciitis (PFs) is inflammation and thickening of the PF where it attaches to the calcaneus. PFs are the most common cause of heel pain. It has been reported to occur in 10% of people during their lifetime. It is more common between the ages of 40-60. Although its main etiology is not fully understood, the most common theory is; microscopic tears as a result of mechanical overstretching of the fascia followed by chronic inflammation, but histological studies lack evidence to support inflammation. Diagnosis is made by physical examination and radiological examinations (ultrasonography, radiography). On physical examination, there is localized tenderness medial to the calcaneal tuberosity. In the treatment of plantar fasciitis, there are many applied methods such as anti-inflammatory agents, orthostotic supports, night splints, physical therapy, corticosteroid applications, night splint use, plastering, rest, lifestyle modification, laser, taping, exercise and ESWT.
Kinesio tapes, which have been used in the conservative treatment of plantar fasciitis in recent years, are elastic tapes similar to the structural properties and flexibility of human skin, without limiting joint movements. Kinesio taping technique provides physiological effects on skin, fascia, muscle and joint. After applying kinesio tape, it raises the skin in the taped area, increasing the space between it and the muscles and relieving the pressure in that area. It also helps to reduce tension and sensitivity by increasing blood circulation and prevents stimulation of pain receptors.
Peloids (medical mud) are organic or inorganic substances formed as a result of geological and/or biological events. They can be found in nature as fine particles, or they are made into small, fine particles by some preliminary preparation processes. Peloidotherapy is a special balneotherapy method made with natural mud. It is used in the treatment of diseases such as degenerative joint diseases, soft tissue rheumatism, lumbardiscopathy, cervical discopathy, chronic low back and neck pain, joint pain. In both national and international scientific studies on peloid treatment, it has been shown that pain in patients decreases, physical functions improve, quality of life increases, and the amount of painkillers use decreases.
We could not find any study comparing Peloidotherapy and Kinesioband methods routinely used in the treatment of PF in the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peloid Therapy | – | Other: Peloid TherapyPeloidotherapy is a special balneotherapy method made with natural mud. In both domestic and international scientific studies on peloid treatment, it has been shown that pain in patients decreases, physical functions improve, quality of life increases, and the amount of painkillers use decreases. |
| Kinesio Tape | – | –Kinesio tapes, which have been used in the conservative treatment of plantar fasciitis in recent years, are elastic tapes similar to the structural properties and flexibility of human skin, without limiting joint movements. |
| Home exercise | – | –In addition to the cold application, gastrocnemius and plantar fascia stretching and strengthening exercises were applied to patients with plantar fasciitis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 105 patients, 35 for peloid treatment, 35 for Kinesio tape, and 35 for home exercise, were included in our study.
Key inclusion criteria (5 listed)
- Pain on the sole of the foot for six weeks or longer,
- Being between the ages of 18-65,
- Pain that is 4 or more severe according to VAS,
- Localized tenderness on palpation medial to the calcaneal tuberosity,
- Heel pain when getting out of bed in the morning or after long periods of inactivity
Key exclusion criteria (13 listed)
- Having neuropathic or radicular pain,
- Acute ankle trauma,
- Having surgical intervention on the heel before,
- Receiving non-operative treatment for the heel and sole in the last 6 months (corticosteroid injection, physical therapy applications, ESWT etc.),
- Presence of rheumatological diseases such as rheumatoid arthritis, psoriatic arthritis,
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 |
|---|---|---|
| Peloid TherapyAlso: Home exercise, Kinesio tapePeloid therapy; A total of 10 sessions were applied for 30 minutes by heating the proximal part of the sole of the foot, including the heel part, at a temperature of 45 degrees. Kinesioband application: One strip is prepared as a rake with a length of about 25 cm, and the other strip is prepared as an I tape with a length of about 20 cm. The ankle is in a neutral position of 90 degrees. Lymphatic and mechanical correction technique is applied. Afterwards, the band is activated. | Other | Peloid Therapy |
Primary outcome
Comparison of the efficacy of kinesio tape and peloid therapy in patients with plantar fasciitis
Time frame: October 2020-February 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fasciitis, run by Konya Meram State Hospital 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Dec 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Mr Gül (+90 544 737 6129, drsuleymangul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the efficacy of kinesio tape and peloid therapy in patients with plantar fasciitis (time frame: October 2020-February 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2021.