Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
USG-guided steroid injection
Palpation-guided steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar Fasciitis, USG, Steroid, Injection
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with plantar fasciitis
- Between the ages of 18-75
- Who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months
- Visual Anolog Scale value of 5 and above will be included in the study.
Exclusion Criteria:
- Having received any local injection therapy and physical therapy for heel pain within the last 4 months,
- Any history of surgery for heel pain, tarsal tunnel syndrome, calcaneal fracture, Achilles tendinopathy, any deformity of the foot and ankle including pes, planus or pes cavus deformity
- with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease, or gout
- Pregnancy
- A recent history of aspirin or aspirin-like medication
- mental disability
Sites / Locations
- Adem ERBİROL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
USG-guided steroid injection group
Palpation-guided steroid injection group
Arm Description
In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
Outcomes
Primary Outcome Measures
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
Secondary Outcome Measures
Foot Function Index
Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.
Foot Function Index
Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.
Foot Function Index
Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.
Full Information
NCT ID
NCT04709484
First Posted
January 12, 2021
Last Updated
October 18, 2021
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT04709484
Brief Title
Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
Official Title
Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Plantar fasciitis, often described as overloading of the plantar fascia, is the most common cause of heel pain in adults. It is characterized by a sharp pain along the medial aspect of the heel, which is worse with the first step taken in the morning or at the beginning of an activity and decreases as the person warms up. The etiology of plantar fasciitis is multifactorial and not well understood. Poor biomechanics and changes in the structure of the foot can lead to repeated micro-trauma at the beginning of the plantar fascia, causing inflammation and degeneration. Plantar fasciitis is more common in sedentary individuals and athletes and those participating in running sports. Other risk factors associated with plantar fasciitis include reduced ankle dorsiflexion, increased body mass index (BMI), and work-related weight loss activities.
Current treatments for plantar fasciitis, such as plantar fascia stretching exercises, strapping, extracorporeal shock wave therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), arch braces, and heel pads are mainly aimed at reducing inflammation. Corticosteroid injections are usually reserved for refractory plantar fasciitis after conservative noninvasive attempts have failed. It has been shown to effectively reduce heel pain in patients with plantar fasciitis. The strong anti-inflammatory effect of corticosteroids can speed up the process of pain relief.
In our study, we aimed to compare the effectiveness of USG and palpation guidance blind steroid injection in patients diagnosed with plantar fasciitis.
Detailed Description
It is planned to enroll 60 (sixty) patients in the study. Patients diagnosed with plantar fasciitis, between the ages of 18-75, who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months, and those with a Visual Anolog Scale value of 5 and above will be included in the study. Any local injection therapy and physical therapy for heel pain in the last 4 months, any surgery history for heel pain, history of tarsal tunnel syndrome, ankle effusion showing intra-articular disease, healed calcaneal fracture, Achilles tendinopathy, foot including pes and any deformity of the ankle, planus or pes cavus deformity; Patients with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease or gout, pregnancy, history of aspirin or aspirin-like medication, and mental insufficiency will be excluded from the study.
In the study, the patients will be filled in Visual Analogue Scale (VAS) and Foot Function Indez (FFI) questionnaires. Patients will be randomized into 2 groups according to the Random Number Generation. The first group will be the USG-guided steroid injection group, and the second group will be the palpation-guided steroid injection group. In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under the guidance of USG. In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone. There will be pre-injection, 1st month and 3rd month controls after injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar Fasciitis, USG, Steroid, Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double(participant, outcomes assesor double)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USG-guided steroid injection group
Arm Type
Experimental
Arm Description
In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
Arm Title
Palpation-guided steroid injection group
Arm Type
Experimental
Arm Description
In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
Intervention Type
Drug
Intervention Name(s)
USG-guided steroid injection
Other Intervention Name(s)
no other names
Intervention Description
In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
Intervention Type
Drug
Intervention Name(s)
Palpation-guided steroid injection
Other Intervention Name(s)
no other names
Intervention Description
In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
Primary Outcome Measure Information:
Title
Pain Severity
Description
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
Time Frame
day 0 (before intervention)
Title
Pain Severity
Description
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
Time Frame
1 month after intervention
Title
Pain Severity
Description
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
Time Frame
3 month after intervention
Secondary Outcome Measure Information:
Title
Foot Function Index
Description
Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.
Time Frame
day 0 (before intervention)
Title
Foot Function Index
Description
Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.
Time Frame
1 month after intervention
Title
Foot Function Index
Description
Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.
Time Frame
3 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with plantar fasciitis
Between the ages of 18-75
Who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months
Visual Anolog Scale value of 5 and above will be included in the study.
Exclusion Criteria:
Having received any local injection therapy and physical therapy for heel pain within the last 4 months,
Any history of surgery for heel pain, tarsal tunnel syndrome, calcaneal fracture, Achilles tendinopathy, any deformity of the foot and ankle including pes, planus or pes cavus deformity
with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease, or gout
Pregnancy
A recent history of aspirin or aspirin-like medication
mental disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adem Erbirol
Organizational Affiliation
Egirdir Bone Joint Diseases Treatment And Rehabilitation Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Adem ERBİROL
City
Isparta
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
other researchers would get information from the main researcher. therefore it was not shared.
Learn more about this trial
Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
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