- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06917937
The Additive Effect of Exercise in Addition to Corticosteroid Injection in Plantar Fasciitis
The Additive Effect of Exercise in Addition to Corticosteroid Injection for Pain and Functional Performance in Plantar Fasciitis: A Single-Center Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kütahya, Turkey (Türkiye), 43000
- Kutahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: (Exercise program in added on to corticosteroid injection (Group I)
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.
|
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.
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. |
|
Active Comparator: Corticosteroid injection (Group II)
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Shortness Tests
Time Frame: a day before the rehabilitation
|
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
Time Frame: up to 3 weeks
|
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
Time Frame: up to 6 weeks
|
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)
Time Frame: a day before the rehabilitation
|
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)
Time Frame: up to 3 weeks
|
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)
Time Frame: up to 6 weeks
|
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)
Time Frame: a day before the rehabilitation
|
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)
Time Frame: up to 3 weeks
|
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)
Time Frame: up to 6 weeks
|
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
Time Frame: a day before the rehabilitation
|
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
Time Frame: up to 3 weeks
|
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
Time Frame: up to 6 weeks
|
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
Time Frame: a day before the rehabilitation
|
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
Time Frame: up to 3 weeks
|
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
Time Frame: up to 6 weeks
|
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
Time Frame: a day before the rehabilitation
|
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
Time Frame: up to 3 weeks
|
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
Time Frame: up to 6 weeks
|
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
Time Frame: a day before the rehabilitation
|
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
Time Frame: up to 3 weeks
|
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
Time Frame: up to 6 weeks
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Skin Diseases
- Behavior
- Skin and Connective Tissue Diseases
- Fasciitis
- Foot Diseases
- Fasciitis, Plantar
- Motor Activity
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
- Adrenal Cortex Hormones
Other Study ID Numbers
- KSBU-PF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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