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

• ClinicalTrials.gov Identifier: NCT04709484
• Recruitment Status: Completed
• First Posted: January 14, 2021
• Results First Posted: October 20, 2021
• Last Update Posted: October 20, 2021
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Information provided by (Responsible Party): Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• 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
• Actual Study Start Date: March 11, 2021
• Actual Primary Completion Date: June 1, 2021
• Actual Study Completion Date: August 1, 2021

Arms and Interventions

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

Outcome Measures

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 more severe pain. Higher values represent a worse outcome.
2. Pain Severity [ Time Frame: 1 month after intervention ]
   visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.
3. Pain Severity [ Time Frame: 3 month after intervention ]
   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 :

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. Higher values represent a worse outcome.
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. Higher values represent a worse outcome.
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. Higher values represent a worse outcome.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Adem ERBİROL

Isparta, Turkey

Sponsors and Collaborators

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

• Study Director: Adem Erbirol; Egirdir Bone Joint Diseases Treatment And Rehabilitation Hospital

  Study Documents (Full-Text)

Documents provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:

Study Protocol  [PDF] March 1, 2021

Statistical Analysis Plan  [PDF] August 1, 2021

More Information

• 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
• Results First Posted: October 20, 2021
• Last Update Posted: October 20, 2021
• Last Verified: October 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.

• 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:

Fasciitis; Fasciitis, Plantar; Musculoskeletal Diseases; Foot Diseases