The Effectiveness of Ultrasound Treatment in the Management of Plantar Fasciitis

NCT04175288 | Unknown

• 1 other identifier: 802-2019-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• Heel raises

  Change measures (baseline and up to 5 weeks)

• 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)

Study Arms (2)

Ultrasound, manual therapy and exercise

EXPERIMENTAL

This group will receive Ultrasound, manual therapy and exercise

Other: Ultrasound, manual therapy and exercise

manual therapy and exercise

ACTIVE COMPARATOR

This group will receive manual therapy and exercise

Other: Ultrasound, manual therapy and exercise

Interventions

Ultrasound, manual therapy and exercise 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.

Ultrasound, manual therapy and exercise; manual therapy and exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Sage Colleges: lead

Study Sites (1)

Neeti Pathare

Troy, New York, 12309, United States

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves; Musculoskeletal Manipulations; Exercise

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erin Elkins

  The Sage Colleges

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeti Pathare

CONTACT

5182443127; pathan@sage.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 25, 2019
• Study Start: November 18, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)