The Effectiveness of 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: Recruiting

Administrative data

• NCT number: NCT04175288
• Other study ID #: 802-2019-2020
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2019
• Source: The Sage Colleges
• Contact: Neeti Pathare
• Phone: 5182443127
• Email: pathan[@]sage.edu
• 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Neeti Pathare	Troy	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Sage Colleges

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change measures (baseline and up to 5 weeks)
Primary	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.	Change measures (baseline and up to 5 weeks)
Primary	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.	Change measures (baseline and up to 5 weeks)
Primary	Heel raises		Change measures (baseline and up to 5 weeks)
Primary	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.	Change measures (baseline and up to 5 weeks)