Plantar FascitisNCT04204824
Ultrasound Treatment in the Management of Plantar Fasciitis
A study testing Ultrasound and exercise in people with Plantar Fascitis, run by The Sage Colleges.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Ultrasound and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis: A Randomized, Placebo-Controlled Study
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.
Read the 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:
- 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.
- Conditions
- Plantar Fascitis
- Being tested
- Ultrasound and exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound and exercise | Experimental | This group will receive ultrasound treatment, strengthening exercises and stretching exercises. Receives: Other: Ultrasound and exercise |
| Sham Ultrasound and exercise | Active comparator | This group will receive sham ultrasound treatment, strengthening exercises and stretching exercises. Receives: Other: Ultrasound and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change measures (baseline and up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Control vs. experimental
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Sage Colleges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204824
- Sponsor's protocol ID
- 399-2015-2016
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis: A Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04204824
- Acronym / sponsor ID
- 399-2015-2016
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Sage CollegesUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups: Control vs. experimental
| Arm | Type | Receives |
|---|---|---|
| Ultrasound and exercise | Experimental | Other: Ultrasound and exerciseThis group will receive ultrasound treatment, strengthening exercises and stretching exercises. |
| Sham Ultrasound and exercise | Active comparator | Other: Ultrasound and exerciseThis group will receive sham ultrasound treatment, strengthening exercises and stretching exercises. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and exerciseThe 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 | Other | Sham Ultrasound and exercise, Ultrasound and exercise |
Primary outcome
Visual Analog scale for pain
Time frame: Change measures (baseline and up to 5 weeks)
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.
Function
Time frame: Change measures (baseline and up to 5 weeks)
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.
Strength
Time frame: Change measures (baseline and up to 5 weeks)
Strength will be measured with a hand held dynamometer for the tibialis anterior, tibialis posterior, peroneus longus and brevis, and gastrocnemius.
Range of Motion
Time frame: Change measures (baseline and up to 5 weeks)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and exercise in people with Plantar Fascitis, run by The Sage Colleges.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog scale for pain (time frame: Change measures (baseline and up to 5 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.