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

Not Applicable

Completed

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

• Registration Number: ISRCTN98064931
• Lead Sponsor: sak University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-02
• Study Start: 2024-08-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary outcome measures are assessed at baseline, 3 days, 30 days, and 90 days post-treatment:<br>1. Pain intensity measured using a Visual Analog Scale (VAS) <br>2. Pressure pain threshold (PPT) measured using a digital algometer

Secondary Outcome Measures

Name	Time	Method
1. Analgesic Use measured using a self-reported diary recorded daily for 90 days post-treatment<br>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<br>3. Functional Improvement measured using the Foot Function Index (FFI) questionnaire at baseline, 30 days, and 90 days post-treatment