Early Intervention With Therapeutic Exercise in Plantar Fasciopathy (PIPex-FP)

April 26, 2024 updated by: Javier Marco Lledó, Universidad Miguel Hernandez de Elche

Efficacy of an Early Intervention Programme Using Therapeutic Exercise in Patients With Plantar Fasciopathy

The aim of this project is to evaluate the efficacy of a therapeutic exercise programme in patients with plantar fasciitis applied early and aimed at strengthening the hip and foot musculature.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients will be informed about the study to be carried out and will give their prior informed consent. The programme has a first part of teaching directed to patients by physiotherapists, and a second part of application at home, with a duration of 12 weeks. An experimental study will be designed with random assignment of patients with similar characteristics to two groups. The non-experimental group will receive their usual treatment (medication and recommnendations as stretching) and the experimental group will follow their usual treatment and also participate in the therapeutic programe.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Javier Marco, PhD
  • Phone Number: 34 965 919405
  • Email: jmarco@umh.es

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with referred pain in the medial plantar area of the heel, accentuated with initial steps after a period of inactivity but also worsening after prolonged body weight bearing, of at least 3 months evolution prior to inclusion in the study.
  • Reproduction of the pain referred by the patient with palpation at the proximal insertion of the plantar fascia.

Exclusion Criteria:

  • Pregnancy.
  • Injection of corticoids in the area in the 6 months prior to recruitment.
  • Previous illnesses that may alter gait (central or peripheral neurological pathology, degenerative and inflammatory arthropathies, systemic illnesses).
  • Existence of concomitant foot pathology (metatarsalgia, stress fractures, neuropathies due to entrapment, tendinitis, history of foot/ankle surgery, etc.).
  • People who do not have the capacity to understand and follow an exercise programme.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
People with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician and will also participate in the therapeutic exercise programme.
Other: Muscle strengthening
Strengthening exercises for the intrinsic muscles of the foot and hips
Active Comparator: Non-experimental group
Individuals with PF who will receive the usual treatment (oral analgesic/anti-inflammatory drug) prescribed by the primary care physician
Drug: Standard treatment (oral analgesic/anti-inflammatory drug)
oral analgesic/anti-inflammatory drug. Education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
For its estimation a numerical pain rating scale will be used, where 0 represents no pain (at all) and 10, the worst pain imaginable. Using this instrument the patient should rate the intensity of pain at the start of walking in the morning (the first step), the worst time of the day and the average level of pain the participant has experienced in the last week. This is an easy to complete, quick and simple scale. A 2-point change on this scale is a clinically important difference in people with chronic pain.
It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
Disability
Time Frame: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
To be estimated using the Spanish version of the foot function index. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability and activity limitation.
It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
General health and health-related quality of life:
Time Frame: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
Is a generic instrument for measuring health-related quality of life. It has 5 health dimensions: mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression. Each of these has three levels of severity
It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
Physical activity
Time Frame: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
t will be measured through the International Physical Activity Questionnaire (IPAQ). This questionnaire consists of 7 items. The aim of this instrument is to record the degree of physical activity, sitting hours and walking time of the subjects who complete it.
It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
Overall perception of clinical change
Time Frame: It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.
The overall rating of change will be obtained using an 11-point scale. It measures the overall perceived change in the condition of their heel pain from the time they started the study to the present as "worse", "no change" or "better".
It will be assessed at baseline and at 12 weeks (at the end of the intervention period), with a subsequent follow-up period at 3 and 6 months after the end of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Investigators

  • Study Chair: Javier Marco, PhD, Universidad Miguel Hernandez de Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2024

Primary Completion (Estimated)

May 10, 2024

Study Completion (Estimated)

February 10, 2025

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProtocoloFP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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