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

NCT04271696 | Unknown

• 1 other identifier: GaziosmanpasaTREH12
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis, Chronic

Keywords

Extracorporeal Shockwave Therapy; Minimal Clinically Important Difference; Pain Measurement; Patient Reported Outcome Measures; Plantar Fasciitis; Responsiveness

Outcome Measures

Primary Outcomes (6)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients queued for ESWT

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Ebru Y Yalcınkaya, Ass. Prof.

  Gaziosmanpasa Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Mehmet A Guler, M.D.

CONTACT

+905054930098; makifguler89@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: February 13, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

TU (1)