- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175288
The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis
The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis: A Randomized, Placebo-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neeti Pathare
- Phone Number: 5182443127
- Email: pathan@sage.edu
Study Locations
-
-
New York
-
Troy, New York, United States, 12309
- Recruiting
- Neeti Pathare
-
Contact:
- Neeti Pathare
- Phone Number: 518-244-3127
- Email: pathan@sage.edu
-
Contact:
- Erin Elkins
- Phone Number: 5182442449
- Email: westee@sage.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultrasound, manual therapy and exercise
This group will receive Ultrasound, manual therapy and exercise
|
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.
|
Active Comparator: manual therapy and exercise
This group will receive manual therapy and exercise
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during ADL
Time Frame: Change measures (baseline and up to 5 weeks)
|
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
|
Change measures (baseline and up to 5 weeks)
|
Range of Motion
Time Frame: Change measures (baseline and up to 5 weeks)
|
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.
|
Change measures (baseline and up to 5 weeks)
|
Functional foot and ankle measure (ADL and sports)
Time Frame: Change measures (baseline and up to 5 weeks)
|
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.
|
Change measures (baseline and up to 5 weeks)
|
Heel raises
Time Frame: Change measures (baseline and up to 5 weeks)
|
Change measures (baseline and up to 5 weeks)
|
|
Navicular drop
Time Frame: Change measures (baseline and up to 5 weeks)
|
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.
|
Change measures (baseline and up to 5 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin Elkins, The Sage Colleges
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 802-2019-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plantar Fascitis
-
Cairo UniversityNot yet recruiting
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...RecruitingPlantar FascitisItaly
-
Chinese University of Hong KongRecruiting
-
Istanbul Medeniyet UniversityNot yet recruiting
-
Chinese University of Hong KongRecruitingPlantar FascitisHong Kong
-
Stanford UniversityNot yet recruitingPlantar Fascitis
-
Hospital for Special Surgery, New YorkActive, not recruiting
-
Riphah International UniversityCompletedPlantar FascitisPakistan
-
Sultan Qaboos UniversityRecruitingPlantar FascitisOman
-
Mike O'Callaghan Military HospitalCompleted
Clinical Trials on Ultrasound, manual therapy and exercise
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosRecruitingEpicondylalgiaUnited States
-
Alabama Physical Therapy & AcupunctureUniversidad Rey Juan CarlosCompletedLateral EpicondylitisUnited States
-
University of PalermoCompleted
-
Proaxis TherapyVirginia Commonwealth University; Arcadia University; National Athletic Trainers...CompletedShoulder Impingement SyndromeUnited States
-
Josue Fernandez CarneroUniversidad Autonoma de MadridCompletedCervicalgia | Neck Pains | Posterior Cervical Pains | Posterior Neck Pain
-
Universidad de ZaragozaCompleted
-
Royal College of Surgeons, IrelandUnknownHip OsteoarthritisIreland
-
University of AlcalaRecruitingTemporomandibular DisorderSpain
-
Universitat Internacional de CatalunyaRecruiting
-
Hasan Kalyoncu UniversityCompletedTemporomandibular Disorders | Dysphagia, Oral PhaseTurkey