Clinical trial NCT04204824: 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: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: The Sage Colleges
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Control vs. experimental
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of ultrasound treatment in addition to an exercise program to improve pain and function in individuals with plantar fasciitis.

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 Few randomized control studies have been published with respect to treatment of PF with ultrasound. Only one study of this nature was published in 1995 by Crawford et al.3 This research found the true ultrasound was no more effective then sham ultrasound and the authors concluded that future studies need to clarify ultrasound parameters with respect to intensity, duty cycle, frequency, area, duration, dosage, and treatment size.

The purpose of this study is to examine the effectiveness of ultrasound treatment in addition to an exercise program to improve pain and function in individuals with plantar fasciitis. The investigator's primary hypothesis is individuals with PF will show a greater improvement in pain and function with ultrasound and an exercise program as compared to just an exercise program alone.

Research Questions for each outcome measure:

1. Following the four week intervention period, the experimental or the True Ultrasound group (TUG) group will show a greater improvement in their pain rating during two different time intervals: Pain in the previous 24 hours and with initial steps in the morning, as well as three different functional activities: Pain during single limb stance, 30 minutes of standing during ADLs, and walking 1000meter (.62miles) according to the Visual Analog Scale (VAS) compared to the control group.

2 Following the four week intervention period, the experimental group, TUG, will show an improved percentage of level of function in ADLs and sports as measured by the Foot and Ankle Ability Measure (FAAM) as compared to the control group.

3 Following the four week intervention period the experimental group, TUG, will demonstrate an improved range of motion (ROM) of ankle dorsiflexion in subtalar neutral as measured by a goniometer as compared to the control group.

4 Following a four week intervention period the experimental group, TUG, will demonstrate an increase in ankle strength of the Anterior Tibialis, Posterior Tibialis, Peroneus Longus, Peroneus Brevis, and Gastrocnemius as measured by a hand held dynamometer as compared to the control group.

Eligibility criteria: Inclusion Criteria:

* a progressive onset of heel pain lasting 6 months or less, localized to the medial calcaneal tubercle and pain with first steps in the morning.

Exclusion Criteria:

* all patients currently receiving treatment for plantar fasciitis within the last 6 months including night splints, orthotic management, 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 with 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
* pregnant women
* Participants with Type I or II Diabetes Mellitis, systemic inflammatory arthritis, cancer, active tuberculosis, psoriasis, decreased circulation, infections, cemented joint replacements
* patients with pacemakers, thrombophlebitis, uncontrolled bleeding or taking blood thinning medication.

Primary outcomes:
measure: Visual Analog scale for pain
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Function
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Strength
timeFrame: Change measures (baseline and up to 5 weeks)
measure: Range of Motion
timeFrame: Change measures (baseline and up to 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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