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Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT04709484
Recruitment Status : Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.


Condition or disease Intervention/treatment Phase
Plantar Fasciitis Drug: USG-guided steroid injection Drug: Palpation-guided steroid injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: double(participant, outcomes assesor double)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Arm Intervention/treatment
Experimental: USG-guided steroid injection group
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.
Drug: USG-guided steroid injection
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.
Other Name: no other names

Experimental: Palpation-guided steroid injection group
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.
Drug: Palpation-guided steroid injection
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.
Other Name: no other names




Primary Outcome Measures :
  1. Pain Severity [ Time Frame: day 0 (before intervention) ]
    visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect

  2. Pain Severity [ Time Frame: 1 month after intervention ]
    visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect

  3. Pain Severity [ Time Frame: 3 month after intervention ]
    visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect


Secondary Outcome Measures :
  1. Foot Function Index [ Time Frame: day 0 (before intervention) ]
    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.

  2. Foot Function Index [ Time Frame: 1 month after intervention ]
    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.

  3. Foot Function Index [ Time Frame: 3 month after intervention ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with plantar fasciitis
  2. Between the ages of 18-75
  3. Who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months
  4. Visual Anolog Scale value of 5 and above will be included in the study.

Exclusion Criteria:

  1. Having received any local injection therapy and physical therapy for heel pain within the last 4 months,
  2. 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
  3. with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease, or gout
  4. Pregnancy
  5. A recent history of aspirin or aspirin-like medication
  6. mental disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709484


Contacts
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Contact: Adem Erbirol +905426608788 aerbirol@hotmail.com

Locations
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Turkey
Adem ERBİROL
Isparta, Turkey
Contact: Adem Erbirol    +905426608788    aerbirol@hotmail.com   
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Investigators
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Study Director: Adem Erbirol Egirdir Bone Joint Diseases Treatment And Rehabilitation Hospital
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Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT04709484    
Other Study ID Numbers: dr.ademerbirol
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: other researchers would get information from the main researcher. therefore it was not shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:
Plantar Fasciitis
USG
Steroid
Injection
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases