Ultrasound Treatment in the Management of Plantar Fasciitis

NCT04204824 | Completed

• 1 other identifier: 399-2015-2016
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Ultrasound and exercise

EXPERIMENTAL

This group will receive ultrasound treatment, strengthening exercises and stretching exercises.

Other: Ultrasound and exercise

Sham Ultrasound and exercise

ACTIVE COMPARATOR

This group will receive sham ultrasound treatment, strengthening exercises and stretching exercises.

Other: Ultrasound and exercise

Interventions

Ultrasound and exercise OTHER

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

Sham Ultrasound and exercise; Ultrasound and exercise

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Sage Colleges: lead

MeSH Terms

Interventions

High-Energy Shock Waves; Exercise

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An independent investigator will set the parameters with the machine outside the treatment area and not in sight of the principal investigator or participant. The face of the machine will then be covered so neither the principal investigator nor the participant can see the settings.The principal investigator and the participants will not be aware of their group assignments until conclusion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: Control vs. experimental

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share