Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar Fasciitis

NCT ID: NCT05589285

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-13
• Study Completion Date: 2025-07-01

Brief Summary

The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.

The hypothesis is that Autologous whole blood (AWB) injection is more effective than sham injections in the treatment of plantar fasciitis.

Participants will receive an autologous whole blood injection over the plantar fascia, and will be followed up to study the response.

Researchers will compare the effects with a control group who will receive normal saline injection.

Detailed Description

Research objectives and hypothesis. The aim of this study is to investigate the effectiveness of whole blood injection as a safe and effective method of treatment of chronic plantar fasciitis.

The hypothesis is that AWB injection is more effective than sham injections in the treatment of plantar fasciitis.

Study design and research methods:

1. Study design:Randomized prospective single blinded study

2. Primary and secondary endpoints:

Patients will be followed 6, 12, 24 weeks, and 12 months after the injection to assess the effects and improvement of symptoms.

The outcomes will be measured using different scales that reflects resolution of symptoms such us: Visual Analog Scale (VAS), Foot Function Index (FFI) Foot and Ankle Ability Measure (FAAM). All questionnaires will be translated to Arabic for Arabic speakers. Moreover, the thickness of the plantar fascia will be measured by ultrasound before and after treatment. The operator of the ultrasound is a foot and ankle consultant trained on operating ultrasound.

3. Study treatments or interventions. Patients with the diagnosis of chronic plantar fasciitis will be recruited to the clinic and asked to participate. The primary investigator and co-investigators will be responsible to explain the nature of the study and take a written informed consent prior to inclusion in the study.

Treatment method for group 1:

Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.

Treatment method for group 2:

This will be the control group (placebo group). Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.

Blinding:

Participants will not be aware on the type of injection they received, as both groups will have their blood withdrawn, and the injection will be prepared and given behind a curtain. Blinding of the investigators during treatment administration is not possible as the color of the syringe will give away the type of injection. The type of injection the patient received will not be mentioned in the electronic patient record. Thus, during all the subsequent follow up visits the investigator will not know which treatment group the patient is in to prevent bias.

Post injection:

All patients will be on the conservative management protocol of physiotherapy and orthotics and they will be instructed to perform stretching exercises on daily basis and to record it in dairy. There will be no restrictions in activity. Patients will be instructed not to use NSAIDs.

Randomization:

Patients will be randomized into two groups with a ratio of 1:1 using a computer based randomization system.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Chronic plantar fasciitis patients who will receive autologous whole blood injection.

Group Type: EXPERIMENTAL

Injection of autologous whole blood to the plantar fascia

Intervention Type: BIOLOGICAL

Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.

Control group

Chronic plantar fasciitis patients who will receive normal saline injection.

Group Type: SHAM_COMPARATOR

Injection of normal saline to the plantar fascia

Intervention Type: DEVICE

This will be the control group receiving sham injection. Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.

Interventions

Injection of autologous whole blood to the plantar fascia

Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe. The patient will be asked to lie down in the clinic bed, and the injection will be administered to the plantar fascia by the principal investigator using a sterile technique.

Intervention Type: BIOLOGICAL

Injection of normal saline to the plantar fascia

This will be the control group receiving sham injection. Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes. They will be asked to lie down on the clinic bed, 1 ml of normal saline will be administered under sterile technique by the principal investigator. The blood that was withdrawn initially will be discarded.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with chronic plantar fasciitis (persistence of symptoms despite 12 weeks of conservative management)
• Age: adults patients more than 18 years
• Not having responded to primary conservative managements such as rest, shoe insoles, conventional physical therapy, exercise therapy, and nonsteroidal anti-inflammatory drugs (NSAIDs).

Exclusion Criteria

1. Neurological or vascular insufficiencies in the painful heel

2. Osteomyelitis, fracture of the calcaneus

3. Recent infection in the treatment area, history of rheumatic diseases

4. Immunosuppressive therapy or coagulation disturbance and/or therapy, long-term treatment with corticosteroids

5. Previous heel surgery

6. Patient with diabetes mellitus,

7. Pregnancy

8. Received corticosteroid injection

9. Four weeks since the last anaesthetic injection, iontophoresis, ultrasound and

10. electromyostimulation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Wafa Al Baluki

Consultant foot and ankle orthopaedics surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wafa Al Baluki

Role: PRINCIPAL_INVESTIGATOR

Sultan Qaboos University Hospital

Locations

Sultan Qaboos Univeristy Hospital

Muscat, , Oman

Site Status: RECRUITING

Countries

Oman

Central Contacts

Wafa Al Baluki, BSc, MD, FRCSC.

Role: CONTACT

albaluki@squ.edu.om

+968 71 9999 31 ext. +968 2414 3486

Asma Al Rasbi, MD

Role: CONTACT

asma.alrasbi@gmail.com

+968 97767028

Facility Contacts

Wafa Al Baluki

Role: primary

albaluki@squ.edu.om

+968 71 9999 31

Other Identifiers

MREC 2864

Identifier Type: -

Identifier Source: org_study_id