Clinical trial NCT04175288: The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis
Official title: The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis: A Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: The Sage Colleges
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of ultrasound treatment in addition to a program consisting of manual therapy and exercise (stretching and strengthening exercises) to improve pain and function in individuals with plantar fasciitis. Our primary hypothesis is individuals with plantar fasciitis will show a greater improvement in pain and function with ultrasound, manual therapy and an exercise program compared to manual therapy and exercise program alone.

Detailed description: Plantar fasciitis (PF) is a common cause of foot pain, affecting an estimated 2 million people per year.1 Although there are large numbers of people seeking medical attention for this condition, there remains some confusion among health care providers as to the most efficacious treatment and some authors conclude that no data solidly supports effectiveness of treatment.2

Several randomized control studies have been published with respect to treatment of PF with ultrasound. The current literature on the effectiveness of US in individuals with PF is largely inconsistent in the parameters. One study by Crawford and Snaith,3 found the true ultrasound was no more effective than sham ultrasound and the authors concluded that future studies need to clarify ultrasound parameters. In contrast, a recent study that utilized different parameters,4 concluded that the US group showed significant changes in pain and function. Strengthening and stretching exercises are well documented through the literature to improve function and decrease pain in patients with PF.5-8 It has been reported within the literature that patients with PF have subtalar, tarsometatarsal, and first metatarsalphangeal (MTP) joint hypo mobility into dorsiflexion, which reduces dorsiflexion range of motion (ROM) and places the windlass mechanism at a mechanical disadvantage which has been theorized to place increased stress on the plantar fascia.9-12 A variety of studies have explored the effects of manual therapy in conjunction with exercises to address the limitations in ankle dorsiflexion ROM.9-12

Eligibility criteria: Inclusion Criteria:

* 18 years and above
* onset of plantar heel pain (localized to the medial calcaneal tubercle and have had pain with first steps in the morning)
* both acute and chronic stages of plantar fasciitis

Exclusion Criteria:

* participants currently receiving treatment for plantar fasciitis within the last 6 months including iontophoresis with dexamethasone or acetic acid, corticosteroid injections, extracorporeal shock wave laser therapy, microwave diathermy, radiotherapy, stereotactic radiofrequency, trigger-point needling with infiltration, and ultrasound
* participants that have numbness or tingling with or without provocation in the lower extremity, undiagnosed pain, strength impairment of the ankle of less than a 3+/5 measured with specific manual muscle tests for the gastrocnemius
* participants who are pregnant
* participants who have Type I or II Diabetes Mellitus, systemic inflammatory arthritis, cancer, pacemakers, active tuberculosis, thrombophlebitis, psoriasis, decreased circulation, bleeding disorders or on blood thinning medications, cemented ankle joint replacements, ankle plastic components, acute lower extremity fracture, joint instability and/or hypermobility and osteoporosis.

Primary outcomes:
measure: Pain during ADL
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Range of Motion
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Functional foot and ankle measure (ADL and sports)
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Heel raises
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Navicular drop
timeFrame: Change measures (baseline and up to 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Troy
country: United States
facility: Neeti Pathare
state: New York
Study officials:
affiliation: The Sage Colleges
name: Erin Elkins
role: PRINCIPAL_INVESTIGATOR
References: