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

NCT04709484 | Completed Results

• 1 other identifier: dr.ademerbirol
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

Plantar Fasciitis; USG; Steroid; Injection

Outcome Measures

Primary Outcomes (3)

• 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.

  day 0 (before intervention)

• 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.

  1 month after intervention

• 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.

  3 month after intervention

Secondary Outcomes (3)

• Foot Function Index

  day 0 (before intervention)

• Foot Function Index

  1 month after intervention

• Foot Function Index

  3 month after intervention

Study Arms (2)

USG-guided steroid injection group

EXPERIMENTAL

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

Palpation-guided steroid injection group

EXPERIMENTAL

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

Interventions

USG-guided steroid injection DRUG

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.

Also known as: no other names

USG-guided steroid injection group

Palpation-guided steroid injection DRUG

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.

Also known as: no other names

Palpation-guided steroid injection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Adem ERBİROL

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Results Point of Contact

• Title: Adem Erbirol
• Organization: SultanAbdulhamid

aerbirol@hotmail.com

+905426608788

Study Officials

• Adem Erbirol

  Egirdir Bone Joint Diseases Treatment And Rehabilitation Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double(participant, outcomes assesor double)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: March 11, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)