NCT06533683

Brief Summary

The term \"heel pain\" is used to describe a common, painful condition that is localized in the plantar part of the heel and worsens when weight is placed on the heel. Patients with heel pain are more likely to have thickened plantar fascia, abnormal plantar fascia tissue, thicker plantar heel fat pad, and calcaneal spur. Calcaneal spurs are bony protrusions that typically occur just in front of the medial calcaneal tuberosity. Systemic medical treatments, physical therapy agents, exercise and local injections are often applied for heel pain caused by plantar fasciitis and calcaneal spur. This study is to examine the effects of ESWT and kinesio taping on pain and other clinical outcomes in patients with calcaneal spurs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

calcaneal spurextracorporeal shock wave therapykinesio tapingplantar fasciitis

Outcome Measures

Primary Outcomes (1)

  • Pain level before treatment and 3rd month after treatment

    Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)

    From enrollment to the end of treatment at 3rd month

Secondary Outcomes (3)

  • Assessment of heel sensitivity

    From enrollment to the end of treatment at 3rd month

  • Assessment of functionality

    From enrollment to the end of treatment at 3rd month

  • Assessment of quality of life

    From enrollment to the end of treatment at 3rd month

Study Arms (2)

Group 1 : ESWT treatment group

ESWT treatment is applied once a week for 5 weeks

Group 2 : Kinesio taping treatment group

Kinesio taping was also applied once a week, for a total of 5 sessions. The rake method was used for kinesio taping.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Şişli Hamidiye Etfal Training and Research Hospital with complaints of heel pain were evaluated. The data of patients who underwent ESWT and kinesio taping were compared with the information on the hospital system.

You may qualify if:

  • Aged 18 years and over with heel pain
  • A calcaneal spur seen on foot radiographs

You may not qualify if:

  • Those who had received a steroid injection into the heel within the past three months
  • Those who had experienced trauma or surgery to the foot and ankle within the past six months
  • Those with a rheumatic disease affecting the foot and ankle (e.g., spondyloarthritis)
  • Those with open wounds or infections in the area to be treated with lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heel SpurFasciitis, Plantar

Condition Hierarchy (Ancestors)

ExostosesHyperostosisBone DiseasesMusculoskeletal DiseasesFoot DiseasesFasciitis

Study Officials

  • Banu Kuran, Professor

    Şişli Hamidiye Etfal Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 1, 2024

Study Start

September 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations