Comparison of Responsiveness of Different Pain and Disability Measurements in Plantar Fasciitis

Comparison of Responsiveness of Different Pain and Disability Measurements in Patients With Plantar Fasciitis

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.

Study Overview

• Status: Unknown
• Conditions: Plantar Fasciitis, Chronic

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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34255
    • Recruiting
    • Gaziosmanpasa Training and Research Hospital
    • Contact: Mehmet Akif Guler, M.D.; Phone Number: 05054930098; Email: makifguler89@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients queued for ESWT

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Pain severity assessment on a line from 0 to 10 points. As "0" means no pain and "10" points is the worst pain ever.	15 days
Numeric Rating Scale	11 points scale as 0 means no pain and 10 points means worst pain ever.	15 days
Heel Tenderness Index	0-3 points according to the palpation of the heel. "0" means no pain, "1" = painful, "2" = painful and winces and "3"= painful,winces and withdraws.	15 days
Foot Function Index	A Foot Function Index was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. Higher scores show higher disability and worst outcomes.	15 days
Foot and Ankle Outcome Score	The Foot and Ankle Outcome Score is an adaption of Knee injury and Osteoarthritis Outcome Score that assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.	15 days
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score	The questionnaire includes nine items that can be divided into three subscales (pain, function and alignment). Each of the nine items is scored, accumulating to a total score ranging from 0 points (indicating severe pain and impairment) to 100 points (no symptoms or impairment).	15 days

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Study Chair: Ebru Y Yalcınkaya, Ass. Prof., Gaziosmanpasa Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Responsiveness; Patient Reported Outcome Measures; Extracorporeal Shockwave Therapy; Plantar Fasciitis; Pain Measurement; Minimal Clinically Important Difference
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: GaziosmanpasaTREH12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No