NCT05153681

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 29, 2021

Last Update Submit

November 29, 2021

Conditions

Keywords

mud therapybalneotherapyathletic Tape

Outcome Measures

Primary Outcomes (1)

  • Comparison of the efficacy of kinesio tape and peloid therapy in patients with plantar fasciitis

    October 2020-February 2021

Study Arms (3)

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.

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.

Interventions

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.

Also known as: Home exercise, Kinesio tape
Peloid Therapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Mud TherapyAthletic Tape

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

BalneologyTherapeuticsBandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

August 20, 2021

Primary Completion

February 10, 2022

Study Completion

February 20, 2022

Last Updated

December 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations