NCT06917937

Brief Summary

Plantar fasciitis (PF) involves the degeneration of the medial calcaneal tuberosity and nearby perifascial tissues in the heel. It is the leading cause of heel pain, typically resulting from repetitive strain on the plantar fascia, causing structural damage. Key risk factors for PF include an increased body mass index in active individuals and a greater range of plantar flexion motion. Treatment options for PF vary, and there is no clear consensus on the most effective approach. Conservative treatments may include rest, stretching exercises for the plantar fascia and Achilles tendon, strengthening exercises for foot intrinsic muscles, nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics, heel pads, dorsiflexion night splints, and corticosteroid injections. These treatments may be used individually or in combination. Corticosteroid injections are the most frequently used invasive treatment. However, there has been limited research examining the effects of corticosteroid injections combined with exercises targeting intrinsic foot muscle strength on functionality and walking distance. The objective of this study was to evaluate the impact of an exercise program added to corticosteroid injections on pain relief and functional performance in individuals with PF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 28, 2025

Last Update Submit

March 7, 2026

Conditions

Keywords

FootFoot DiseasePlantar FasciitisExerciseSteroid

Outcome Measures

Primary Outcomes (21)

  • Muscle Shortness Tests

    Plantar and Dorsi Flexion Flexibility, Gastrocnemius Shortness, Hamstring Shortness, Hip Flexor Shortness, Tensor Fascia Lata Shortness shortness tests were performed.

    a day before the rehabilitation

  • Muscle Shortness Tests

    Plantar and Dorsi Flexion Flexibility, Gastrocnemius Shortness, Hamstring Shortness, Hip Flexor Shortness, Tensor Fascia Lata Shortness shortness tests were performed.

    up to 3 weeks

  • Muscle Shortness Tests

    Plantar and Dorsi Flexion Flexibility, Gastrocnemius Shortness, Hamstring Shortness, Hip Flexor Shortness, Tensor Fascia Lata Shortness shortness tests were performed.

    up to 6 weeks

  • American Orthopedic Foot and Ankle Society Hindfoot Clinical Evaluation System (AOFAS- hindfoot)

    The AOFAS hindfoot clinical assessment system evaluates the ankle, subtalar, talonavicular, and calcaneocuboid joints. The scoring system allocates 50 points for function, 40 points for pain, and 10 points for alignment. A higher score indicates a better condition for the patient.

    a day before the rehabilitation

  • American Orthopedic Foot and Ankle Society Hindfoot Clinical Evaluation System (AOFAS- hindfoot)

    The AOFAS hindfoot clinical assessment system evaluates the ankle, subtalar, talonavicular, and calcaneocuboid joints. The scoring system allocates 50 points for function, 40 points for pain, and 10 points for alignment. A higher score indicates a better condition for the patient.

    up to 3 weeks

  • American Orthopedic Foot and Ankle Society Hindfoot Clinical Evaluation System (AOFAS- hindfoot)

    The AOFAS hindfoot clinical assessment system evaluates the ankle, subtalar, talonavicular, and calcaneocuboid joints. The scoring system allocates 50 points for function, 40 points for pain, and 10 points for alignment. A higher score indicates a better condition for the patient.

    up to 6 weeks

  • American Orthopedic Foot and Ankle Society Midfoot Clinical Evaluation System (AOFAS- midfoot)

    This scale allocates 45 points for function, 40 points for pain, and 15 points for alignment. Higher scores indicate that the patient's condition is favorable.

    a day before the rehabilitation

  • American Orthopedic Foot and Ankle Society Midfoot Clinical Evaluation System (AOFAS- midfoot)

    This scale allocates 45 points for function, 40 points for pain, and 15 points for alignment. Higher scores indicate that the patient's condition is favorable.

    up to 3 weeks

  • American Orthopedic Foot and Ankle Society Midfoot Clinical Evaluation System (AOFAS- midfoot)

    This scale allocates 45 points for function, 40 points for pain, and 15 points for alignment. Higher scores indicate that the patient's condition is favorable.

    up to 6 weeks

  • Foot Function Index

    It is a 23-item questionnaire designed to assess how foot pathology affects pain, disability, and activity limitations. The FFI score was calculated based on 5 questions related to pain (with a maximum of 50 points). Each question was scored on a scale from 0 to 10, where 0 represents no pain and 10 indicates unbearable pain. In our study, we utilized the Turkish version of the FFI questionnaire.

    a day before the rehabilitation

  • Foot Function Index

    It is a 23-item questionnaire designed to assess how foot pathology affects pain, disability, and activity limitations. The FFI score was calculated based on 5 questions related to pain (with a maximum of 50 points). Each question was scored on a scale from 0 to 10, where 0 represents no pain and 10 indicates unbearable pain. In our study, we utilized the Turkish version of the FFI questionnaire.

    up to 3 weeks

  • Foot Function Index

    It is a 23-item questionnaire designed to assess how foot pathology affects pain, disability, and activity limitations. The FFI score was calculated based on 5 questions related to pain (with a maximum of 50 points). Each question was scored on a scale from 0 to 10, where 0 represents no pain and 10 indicates unbearable pain. In our study, we utilized the Turkish version of the FFI questionnaire.

    up to 6 weeks

  • 6-minute walk test

    The 6MWT is a simple, safe, and well-tolerated test that effectively reflects daily life activities. In our study, the 6MWT was conducted in a 30-meter long, flat, enclosed corridor. We measured the patient's heart rate, respiratory rate, and blood pressure before the test, immediately after completion, and again 5 minutes later. Fatigue levels were evaluated using the Borg Scale, and the distance walked by the patient was recorded in meters.

    a day before the rehabilitation

  • 6-minute walk test

    The 6MWT is a simple, safe, and well-tolerated test that effectively reflects daily life activities. In our study, the 6MWT was conducted in a 30-meter long, flat, enclosed corridor. We measured the patient's heart rate, respiratory rate, and blood pressure before the test, immediately after completion, and again 5 minutes later. Fatigue levels were evaluated using the Borg Scale, and the distance walked by the patient was recorded in meters.

    up to 3 weeks

  • 6-minute walk test

    The 6MWT is a simple, safe, and well-tolerated test that effectively reflects daily life activities. In our study, the 6MWT was conducted in a 30-meter long, flat, enclosed corridor. We measured the patient's heart rate, respiratory rate, and blood pressure before the test, immediately after completion, and again 5 minutes later. Fatigue levels were evaluated using the Borg Scale, and the distance walked by the patient was recorded in meters.

    up to 6 weeks

  • 50 meters walking test

    The test evaluates walking ability, and patients were instructed to walk at their own comfortable pace for a distance of 50 meters. The stopwatch was started with the command to begin at the starting point. Upon reaching the 50-meter mark, we stopped the stopwatch and recorded the time.

    a day before the rehabilitation

  • 50 meters walking test

    The test evaluates walking ability, and patients were instructed to walk at their own comfortable pace for a distance of 50 meters. The stopwatch was started with the command to begin at the starting point. Upon reaching the 50-meter mark, we stopped the stopwatch and recorded the time.

    up to 3 weeks

  • 50 meters walking test

    The test evaluates walking ability, and patients were instructed to walk at their own comfortable pace for a distance of 50 meters. The stopwatch was started with the command to begin at the starting point. Upon reaching the 50-meter mark, we stopped the stopwatch and recorded the time.

    up to 6 weeks

  • Visual Analogue Scale

    Patients were asked to indicate their current pain level on a visual analog scale, which consisted of a 10 cm line. The distance was then measured using a ruler and recorded. A lower score indicates decreased pain.

    a day before the rehabilitation

  • Visual Analogue Scale

    Patients were asked to indicate their current pain level on a visual analog scale, which consisted of a 10 cm line. The distance was then measured using a ruler and recorded. A lower score indicates decreased pain.

    up to 3 weeks

  • Visual Analogue Scale

    Patients were asked to indicate their current pain level on a visual analog scale, which consisted of a 10 cm line. The distance was then measured using a ruler and recorded. A lower score indicates decreased pain.

    up to 6 weeks

Study Arms (2)

(Exercise program in added on to corticosteroid injection (Group I)

EXPERIMENTAL

Our exercise program in our study; (i) foot intrinsic muscle strengthening exercise (with a load of 3 kg), (ii) plantar fascia stretching with finger extension, (iii) standing gastrocnemius muscle stretching, (iv) sitting achilles tendon stretching, (v) plantar fascia and gastrocnemius stretch on the step, (vi) cold massage exercise in the arch of the foot. We stated that the group to which exercise was added should do the exercises regularly for 6 weeks, in the specified number and time.

Other: Exercise ProgramOther: Corticosteroid injection

Corticosteroid injection (Group II)

ACTIVE COMPARATOR

The orthopedic physician administered the corticosteroid injection as a mixture of 1 ml of arthropane (5 mg of triamcinolone hexacetonide) and 4 ml of citanest. Before the application, the physician cleaned the area to be treated with 10% povidone iodine. He made a single dose injection by entering the painful point determined by palpation around the calcaneal spur and plantar fascia from the percutaneous foot-heel lateral. The patients were in the prone position with the ankle in a neutral position.

Other: Corticosteroid injection

Interventions

Our exercise program in our study; (i) foot intrinsic muscle strengthening exercise (with a load of 3 kg), (ii) plantar fascia stretching with finger extension, (iii) standing gastrocnemius muscle stretching, (iv) sitting achilles tendon stretching, (v) plantar fascia and gastrocnemius stretch on the step, (vi) cold massage exercise in the arch of the foot. We stated that the group to which exercise was added should do the exercises regularly for 6 weeks, in the specified number and time.

(Exercise program in added on to corticosteroid injection (Group I)

The orthopedic physician administered the corticosteroid injection as a mixture of 1 ml of arthropane (5 mg of triamcinolone hexacetonide) and 4 ml of citanest. Before the application, the physician cleaned the area to be treated with 10% povidone iodine. He made a single dose injection by entering the painful point determined by palpation around the calcaneal spur and plantar fascia from the percutaneous foot-heel lateral. The patients were in the prone position with the ankle in a neutral position. After the application, he covered the area with a sterile cloth and said to remove it after 3 hours. He stated that patients could apply ice to the injected area if necessary for pain control, and advised patients to avoid all jogging and other high-impact activities on the day of injection. No additional treatments, including NSAIDs, orthoses, and night splints, were allowed during the study period.

(Exercise program in added on to corticosteroid injection (Group I)Corticosteroid injection (Group II)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those over the age of 18
  • Those who have pain in the plantar region for 1 month and this pain is 5 or more according to VAS,
  • Those who describe pain on the first step of the morning,
  • Those with plantar fascia tenderness on palpation,
  • Patients who will be in harmony with the physician and physiotherapist in exercise and follow-up throughout the entire study period.

You may not qualify if:

  • Cases with fracture, entrapment neuropathy and rupture,
  • Those with neurological and systemic diseases,
  • Those with a Body Mass Index (BMI) of more than 40,
  • Conditions with a local contraindication to corticosteroid,
  • Participants who have situations that may prevent their safety, execution or interpretation of the results during the continuation of the training and applied of the test protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot DiseasesFasciitis, PlantarMotor Activity

Interventions

Resistance TrainingAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFasciitisBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective single-center study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 9, 2025

Study Start

September 16, 2018

Primary Completion

March 3, 2019

Study Completion

May 5, 2019

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations