Clinical trial NCT04271696: Comparison of Responsiveness of Different Pain and Disability Measurements in Plantar Fasciitis
Official title: Comparison of Responsiveness of Different Pain and Disability Measurements in Patients With Plantar Fasciitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plantar Fasciitis, Chronic
Keywords: Extracorporeal Shockwave Therapy
Minimal Clinically Important Difference
Pain Measurement
Patient Reported Outcome Measures
Plantar Fasciitis
Responsiveness
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients queued for ESWT

Brief summary: The aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the Physical Medicine and Rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave therapy (ESWT) treatment.

Detailed description: The study was designed as prospective observational research. Between December 2019 and May 2020, 90 patients who were admitted to the Physical Therapy and Rehabilitation outpatient clinic for ESWT were planned to be included in the study. Pre-treatment pain values of patients with 3 different examination methods (visual analog scale, numerical pain scale and heel sensitivity index), 3 different disability index Foot function index, Foot and Ankle Outcome Score, The American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score will be used.

These methods will be evaluated before and after ESWT treatment and the responsiveness and minimal clinically important difference of the questionnaires will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years and older
* Patients with chronic heel complaints for more than 1 month
* Patients queued for ESWT

Exclusion Criteria:

* Patients under the age of 18
* Patients who do not want to participate in the study voluntarily
* Patient undergone physical therapy for the same heel in the last 6 months
* Patients treated for heel pain
* Rheumatologic diseases that cause heel pain (ankylosing spondylitis, Behçet's disease)
* Neurological diseases (such as diabetic polyneuropathy, postpolio syndrome)
* Patients with malignancy
* Illiterate patients with speech pathology

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 15 days
measure: Numeric Rating Scale
timeFrame: 15 days
measure: Heel Tenderness Index
timeFrame: 15 days
measure: Foot Function Index
timeFrame: 15 days
measure: Foot and Ankle Outcome Score
timeFrame: 15 days
measure: American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: Gaziosmanpasa Training and Research Hospital
name: Ebru Y Yalcınkaya, Ass. Prof.
role: STUDY_CHAIR
References: