VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148, United States
NCT Number: NCT05367271
This single-blinded, randomized-controlled trial compares the efficacy of ultrasound-guided onabotulinumtoxinA (BTX-A) injections to the flexor digitorum brevis with current standard of care corticosteroid injections to the plantar fascia for the treatment of refractory plantar fasciitis in patients that have failed six weeks of non-operative treatment.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Salt Lake City, Utah, 84148, United States
Treatment of plantar fasciitis is not well described in the current literature, often making management difficult for both providers and patients. Recent literature has suggested potential use of Onabotulinumtoxin A (BTX-A) as an effective treatment to reduce pain and allow patients to return to their previous level of functional activity. The study will consist of veteran patients at the George E Wahlen Department of Veteran's Affairs (SLC VA) in Salt Lake City, UT. This pilot study aims to randomize patients with plantar fasciitis into current standard of care treatment with corticosteroid injection into the plantar fascia and experimental treatment with BTX-A injection into the flexor digitorum brevis cohorts. We predict that those who receive BTX-A injections will report better outcomes on the Numeric Pain Rating Scale (NPRS) as well as the Foot and Ankle Ability Measure (FAAM) when compared to those receiving corticosteroid. The results of this study could aid in providing evidence towards more reliable and beneficial treatment of plantar fasciitis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20 units of Onabotulinum A in 200 µL of saline injected into the flexor digitorum brevis via ultrasound-guidance
Other names: OnabotulinumtoxinA, BTX-A
1 mL of 4 mg/mL dexamethasone with 2 mL of 1% lidocaine OR 1 mL of 4 mg/mL dexamethasone, 1 mL of 2% lidocaine and 1 mL saline injected into the plantar fascia
Other names: Cortisone
Time frame: Baseline to 1 (primary endpoint), 3, and 6 months
Measured via patient-reported Numeric Pain Rating Scale (NPRS)
Time frame: Baseline to 1 (primary endpoint), 3, and 6 months
Measured via patient-reported Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline to 1 (primary endpoint), 3, and 6 months
Measure how long therapeutic relief lasts
Western Institute for Veterans Research
Other
The Efficacy of Botulinum Toxin to the Flexor Digitorum Brevis Versus Corticosteroid to the Plantar Fascia for the Treatment of Refractory Plantar Fasciitis: A Randomized-Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07462169
Fasciitis, Fasciitis, Plantar
Banhā, Egypt
View Trial DetailsNCT07662941
Fasciitis, Fasciitis, Plantar
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07463794
Bone Diseases, Calcaneal Spur
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07616492
Fasciitis, Fasciitis, Plantar
Lahore, Punjab Province, Pakistan
View Trial Details