The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis

NCT ID: NCT04175288

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2021-12-31

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

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultrasound, manual therapy and exercise

This group will receive Ultrasound, manual therapy and exercise

Group Type: EXPERIMENTAL

Ultrasound, manual therapy and exercise

Intervention Type: OTHER

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.

manual therapy and exercise

This group will receive manual therapy and exercise

Group Type: ACTIVE_COMPARATOR

Ultrasound, manual therapy and exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Sage Colleges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Elkins

Role: PRINCIPAL_INVESTIGATOR

The Sage Colleges

Locations

Neeti Pathare

Troy, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Neeti Pathare

Role: CONTACT

pathan@sage.edu

5182443127

Facility Contacts

Neeti Pathare

Role: primary

pathan@sage.edu

518-244-3127

Erin Elkins

Role: backup

westee@sage.edu

5182442449

Other Identifiers

802-2019-2020

Identifier Type: -

Identifier Source: org_study_id