An interventional study of Injection of autologous whole blood to the plantar fascia and Injection of normal saline to the plantar fascia in Plantar Fascitis, sponsored by Sultan Qaboos University. Recruiting at 1 site in Oman. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Sultan Qaboos University · Not applicable, Interventional, and Treatment
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.
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:
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.
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Patients assigned in this group will have 2 ml of blood withdrawn from a peripheral vein, then mixed with 1 mL Lidocaine 2% for a total of 3mL volume in one syringe.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 Patients will have 2 ml of blood withdrawn from a peripheral vein for blinding proposes.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.
223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.
Browse Fasciitis, Plantar studies →Sultan Qaboos University is the lead sponsor of 50 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic plantar fasciitis patients who will receive autologous whole blood injection.
Biological: Injection of autologous whole blood to the plantar fascia
Chronic plantar fasciitis patients who will receive normal saline injection.
Device: Injection of normal saline 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.
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.
Visual Analog Scale
Visual Analog Scale (VAS) to assess the pain score from 0 (minimum) to 10 (maximum)
Time frame: 12 months
Foot Function Index
a questionnaire based index to assess the foot function (from 0% minimum to 100% maximum)
Time frame: 12 months
Foot and Ankle Ability Measure (FAAM)
a questionnaire based index to assess foot and ankle ability in various daily life activities.
Time frame: 12 months
Change in Plantar fascia thickness
Measurement of the change in plantar fascia thickness using ultrasound
Time frame: before the treatment and 12 months after the treatment.
Started Jul 2023 (actual). Primary completion is estimated for Jul 2024, 11 months after the start.
Of 104 non-industry interventional studies with no phase under Fasciitis, Plantar, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 11 months is close to that.
Counting every sponsor, half of 109 studies reached it within 11 months; a quarter within 6 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sultan Qaboos University