The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis

Sponsor

Western Institute for Veterans Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT05367271

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fasciitis	Drug: Botulinum Toxin A Drug: Dexamethasone	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum Toxin A (BTX-A)	Drug: Botulinum Toxin A 20 units of Onabotulinum A in 1 mL of saline injected into the flexor digitorum brevis via ultrasound-guidance Other Names: OnabotulinumtoxinA BTX-A
Active Comparator: Corticosteroid	Drug: Dexamethasone 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

Arm

Intervention/Treatment

Experimental: Botulinum Toxin A (BTX-A)

Drug: Botulinum Toxin A

20 units of Onabotulinum A in 1 mL of saline injected into the flexor digitorum brevis via ultrasound-guidance

Other Names:

OnabotulinumtoxinA

BTX-A

Active Comparator: Corticosteroid

Drug: Dexamethasone

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

Outcome Measures

Primary Outcome Measures

Change in general pain levels [Baseline to 1 (primary endpoint), 3, and 6 months]
Measured via patient-reported Numeric Pain Rating Scale (NPRS)

Secondary Outcome Measures

Change in foot and ankle-induced difficulties with activities of daily living [Baseline to 1 (primary endpoint), 3, and 6 months]
Measured via patient-reported Foot and Ankle Ability Measure (FAAM)
Number of subjects dropping out for repeat injection or surgical intervention [Baseline to 1 (primary endpoint), 3, and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed increased pain when pressure applied at the medial calcaneal tubercle
X-ray negative for calcaneal fractures, tumors, enthesopathy or osteoarthritis
Patient with plantar fasciitis who have failed 6 weeks of non-operative treatment