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The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound, manual therapy and exercise
Sponsored by
The Sage Colleges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Neeti PathareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound, manual therapy and exercise

manual therapy and exercise

Arm Description

This group will receive Ultrasound, manual therapy and exercise

This group will receive manual therapy and exercise

Outcomes

Primary Outcome Measures

Pain during ADL
The Numerical Rating Scale/Numerical Pain Rating Scale (NPRS) is a pain scale that has been proven to be a reliable and valid outcome measure when used to assess chronic pain
Range of Motion
Dorsiflexion active range of motion will be measured at baseline and at the conclusion of the study by the other principal investigator. Participants will be in a weight-bearing lunge position with the leg to be measured in front and toes facing the wall. The participant will be asked to maximally bend the knee without lift of the heel.
Functional foot and ankle measure (ADL and sports)
The Foot and Ankle Ability Measure (FAAM) is a functional outcome measure validated in the physical therapy setting.20 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.
Heel raises
Navicular drop
All subjects will be seated in a chair with the hips and knees flexed to 90 degrees. The subtalar joint neutral position will be 1st identified through appropriate technique. Following this, the examiner will identify the most anterior and inferior position of the navicular tuberosity and mark it with a washable fine tip marker. The participant will be asked to hold that position while the height of the navicular tuberosity will be measured with a digital caliper. Following measurements in seated position for both feet, participants will be asked to stand and assume a relaxed stance position. The process measuring the navicular height position with a digital caliper as described above in seated position will be repeated in standing position. The difference between the seated and standing navicular positions will be defined as the Navicular drop.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2019
Last Updated
November 21, 2019
Sponsor
The Sage Colleges
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1. Study Identification

Unique Protocol Identification Number
NCT04175288
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Sage Colleges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound, manual therapy and exercise
Arm Type
Experimental
Arm Description
This group will receive Ultrasound, manual therapy and exercise
Arm Title
manual therapy and exercise
Arm Type
Active Comparator
Arm Description
This group will receive manual therapy and exercise
Intervention Type
Other
Intervention Name(s)
Ultrasound, manual therapy and exercise
Intervention Description
The experimental group will receive ultrasound (US) for 3 sessions a week for 4 weeks, with continuous US (1.8 w/cm2, 1 Mega Hz 8 minutes). Manual therapy will include posterior glides to talocrural joint, subtalar lateral glide, a 1st tarsometatarsal joint dorsal glide and extension mobilization to the 1st metatarsophalangeal joint. All participants in each group will be given specific exercises by the investgators targeting intrinsic and extrinsic muscles of the foot and ankle. Specific stretches for the plantar fascia and Achilles tendon, will be performed. Home exercises will be recorded using a log.
Primary Outcome Measure Information:
Title
Pain during ADL
Description
The Numerical Rating Scale/Numerical Pain Rating Scale (NPRS) is a pain scale that has been proven to be a reliable and valid outcome measure when used to assess chronic pain
Time Frame
Change measures (baseline and up to 5 weeks)
Title
Range of Motion
Description
Dorsiflexion active range of motion will be measured at baseline and at the conclusion of the study by the other principal investigator. Participants will be in a weight-bearing lunge position with the leg to be measured in front and toes facing the wall. The participant will be asked to maximally bend the knee without lift of the heel.
Time Frame
Change measures (baseline and up to 5 weeks)
Title
Functional foot and ankle measure (ADL and sports)
Description
The Foot and Ankle Ability Measure (FAAM) is a functional outcome measure validated in the physical therapy setting.20 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.
Time Frame
Change measures (baseline and up to 5 weeks)
Title
Heel raises
Time Frame
Change measures (baseline and up to 5 weeks)
Title
Navicular drop
Description
All subjects will be seated in a chair with the hips and knees flexed to 90 degrees. The subtalar joint neutral position will be 1st identified through appropriate technique. Following this, the examiner will identify the most anterior and inferior position of the navicular tuberosity and mark it with a washable fine tip marker. The participant will be asked to hold that position while the height of the navicular tuberosity will be measured with a digital caliper. Following measurements in seated position for both feet, participants will be asked to stand and assume a relaxed stance position. The process measuring the navicular height position with a digital caliper as described above in seated position will be repeated in standing position. The difference between the seated and standing navicular positions will be defined as the Navicular drop.
Time Frame
Change measures (baseline and up to 5 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeti Pathare
Phone
5182443127
Email
pathan@sage.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Elkins
Organizational Affiliation
The Sage Colleges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neeti Pathare
City
Troy
State/Province
New York
ZIP/Postal Code
12309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeti Pathare
Phone
518-244-3127
Email
pathan@sage.edu
First Name & Middle Initial & Last Name & Degree
Erin Elkins
Phone
5182442449
Email
westee@sage.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis

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