Ultrasound Treatment in the Management of Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis: A Randomized, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204824
• Other study ID #: 399-2015-2016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: December 2019
• Source: The Sage Colleges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Other:
• Ultrasound and exercise
The control group's ultrasound will be set at an intensity of 0 w/cm2. The first 3 treatments to the experimental group will be continuous ultrasound with an intensity of 1.0w/cm2 for 7 minutes. The next 6 treatments for the experimental group (2 times a week for 3 weeks) will have pulsed ultrasound at an intensity of 1.0w/cm2 with a 50% (1:1) duty cycle for 10 minutes. All will have a frequency of 3 MHZ. All participants in each group will be given specific exercises targeting intrinsic and extrinsic muscles of the foot and ankle. Exercises will be performed with a level of thera-band that is challenging to the individual participant in each plane of motion without increased pain for 3 sets of 10 repetitions each and one time each day independently at home during the duration of the treatment protocol (4 weeks) and recorded in an exercise log diary Specific stretches for the plantar fascia and Achilles tendon will be performed 3 times each for 30 second intervals and at home

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Sage Colleges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog scale for pain	The Visual Analog Scale will be used to measure pain at the initial evaluation and at the conclusion of the study for the following intervals: 1) over the previous 24 hour period, 2) with the initial steps first thing in the morning, 3) in single limb stance, 4) after standing for 30 minutes in the course of the participants normal standing activities, and 5) after walking for 1000 meters. This scale has a minimum value of 0 and a maximum value of 10. Higher scores mean worst outcomes.	Change measures (baseline and up to 5 weeks)
Primary	Function	The Foot and Ankle Ability Measure is a functional outcome measure validated in the physical therapy setting.7 It will be used to measure differences in ability in activities of daily living and sports at the initial evaluation and at the conclusion of the study. The final score is reported in % (100% being the maximum value). Higher scores reflect better outcomes.	Change measures (baseline and up to 5 weeks)
Primary	Strength	Strength will be measured with a hand held dynamometer for the tibialis anterior, tibialis posterior, peroneus longus and brevis, and gastrocnemius.	Change measures (baseline and up to 5 weeks)
Primary	Range of Motion	Dorsiflexion active range of motion (AROM) and dorsiflexion passive range of motion (PROM) measurements will be collected at the initial evaluation and at the conclusion of the treatment protocol. Dorsiflexion AROM and PROM will be measured in prone with the forefoot aligned in the frontal plane, the subtalar joint in neutral, the goniometer measuring the sagittal plane with the proximal arm aligned with the fibular head and the distal arm aligned along the lateral border of the 5th metatarsal by the principal investigator.	Change measures (baseline and up to 5 weeks)