Evaluating the effectiveness of load restriction in enhancing recovery after autologous whole-blood injection for plantar fasciitis

In patients with chronic plantar fasciitis, does post-injection load restriction compared to no load restriction improve recovery time and pain reduction following autologous whole-blood injection?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98064931

Enrollment

152

Registered

2024-08-09

Start date

2023-03-02

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery from plantar fasciitis in adults undergoing autologous whole-blood injection with and without load restriction Skin and Connective Tissue Diseases

Interventions

In this interventional study, adult patients diagnosed with plantar fasciitis who did not respond to at least two months of conservative treatment are randomly assigned to one of two groups. Interven

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age Range: 20 to 65 years old 2. Diagnosis: Diagnosed with plantar fasciitis that has not responded to at least two months of conservative treatment 3. Treatment History: No prior history of autologous whole-blood injections for plantar fasciitis 4. Consent: Willingness to provide informed consent for participation in the study 5. Mobility: Capable of using Canadian crutches if assigned to the load restriction group 6. Health Status: No significant systemic diseases or conditions affecting the foot or plantar fascia

Exclusion criteria

Exclusion criteria: 1. Heavy Labor Employment: Participants who are employed in jobs involving heavy physical labor 2. Use of Immunomodulatory Drugs: Individuals who are currently using immunomodulatory medications 3. Previous Injection History: Patients with a history of previous injections for plantar fasciitis 4. Bilateral Plantar Fasciitis: Individuals diagnosed with plantar fasciitis in both feet 5. Previous Foot Surgery: Patients who have undergone foot surgery in the past 6. Local Anesthetic Sensitivity: Individuals with known sensitivity or adverse reactions to local anesthetics 7. Rheumatological Diseases: Participants with diagnosed rheumatological conditions 8. Autoimmune/Neuropathic Diseases: Individuals with autoimmune or neuropathic disorders

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 13/01/2025: The following primary outcome measures are assessed at baseline, 3 days, 30 days, 90 days, and one-year post-treatment: 1. Pain intensity measured using a Visual Analog Scale (VAS) 2. Pressure pain threshold (PPT) measured using a digital algometer Previous primary outcome measure: The following primary outcome measures are assessed at baseline, 3 days, 30 days, and 90 days post-treatment: 1. Pain intensity measured using a Visual Analog Scale (VAS) 2. Pressure pain threshold (PPT) measured using a digital algometer	—

Measure

Time frame

Current primary outcome measure as of 13/01/2025: The following primary outcome measures are assessed at baseline, 3 days, 30 days, 90 days, and one-year post-treatment: 1. Pain intensity measured using a Visual Analog Scale (VAS) 2. Pressure pain threshold (PPT) measured using a digital algometer Previous primary outcome measure: The following primary outcome measures are assessed at baseline, 3 days, 30 days, and 90 days post-treatment: 1. Pain intensity measured using a Visual Analog Scale (VAS) 2. Pressure pain threshold (PPT) measured using a digital algometer

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Secondary

Measure	Time frame
Current secondary outcome measures as of 13/01/2025: 1. Analgesic Use measured using a self-reported diary recorded daily for 90 days post-treatment 2. Time to Return to Normal Activities measured using a patient-reported assessment of when they can comfortably resume daily activities at 3 days, 30 days, and 90 days post-treatment Previous secondary outcome measures: 1. Analgesic Use measured using a self-reported diary recorded daily for 90 days post-treatment 2. Time to Return to Normal Activities measured using a patient-reported assessment of when they can comfortably resume daily activities at 3 days, 30 days, and 90 days post-treatment 3. Functional Improvement measured using the Foot Function Index (FFI) questionnaire at baseline, 30 days, and 90 days post-treatment	—

Measure

Time frame

Current secondary outcome measures as of 13/01/2025: 1. Analgesic Use measured using a self-reported diary recorded daily for 90 days post-treatment 2. Time to Return to Normal Activities measured using a patient-reported assessment of when they can comfortably resume daily activities at 3 days, 30 days, and 90 days post-treatment Previous secondary outcome measures: 1. Analgesic Use measured using a self-reported diary recorded daily for 90 days post-treatment 2. Time to Return to Normal Activities measured using a patient-reported assessment of when they can comfortably resume daily activities at 3 days, 30 days, and 90 days post-treatment 3. Functional Improvement measured using the Foot Function Index (FFI) questionnaire at baseline, 30 days, and 90 days post-treatment

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Countries

Türkiye

Contacts

Public ContactOguzhan Gökalp

oguzhan.gokalp@usak.edu.tr+905059503231

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026