Clinical trial NCT05589285: Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar Fasciitis
Official title: Outcomes of Autologous Whole Blood Injection for the Treatment of Plantar: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Keywords: plantar fasciitis
Whole blood injection
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 12 months
measure: Foot Function Index
timeFrame: 12 months
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 12 months
measure: Change in Plantar fascia thickness
timeFrame: before the treatment and 12 months after the treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Sultan Qaboos Univeristy Hospital
Study officials:
affiliation: Sultan Qaboos University Hospital
name: Wafa Al Baluki
role: PRINCIPAL_INVESTIGATOR
References: