Plantar Fasciitis and Therapeutic Ultrasound

NCT02679326 | Completed

• 1 other identifier: 4/2015
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).

Conditions

Plantar Fasciitis

Keywords

Therapeutic ultrasound, Treatment, Plantar fasciitis

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NPRS) at morning

  pain level at the heel at the first step in the morning.

  at morning after 4 weeks of treatment

Secondary Outcomes (3)

• NPRS during the day

  1 day

• Foot & Ankle computerized adaptive test (CAT)

  2 & 4 weeks of treatment

• Algometric test

  4 weeks of treatment

Study Arms (2)

study group

EXPERIMENTAL

will receive stretching guidance and high level active Ultrasound

Device: Therapeutic ultrasound

control group

PLACEBO COMPARATOR

will receive stretching guidance and very low level of Ultrasound

Device: Therapeutic ultrasound

Interventions

Therapeutic ultrasound DEVICE

control group; study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Worsening symptoms first steps in the morning or at the beginning of walking after sitting for long periods, and after long walking or standing.
• Pain at the bottom of the heel produced by weight bearing or local press.
• Pain level 3 or higher on NPRS at first steps in the morning.
• Tenderness, swelling, or both in the region of proximal plantar fascia and at medial plantar tuberosity of the calcaneous.
• Gradual development of pain at the bottom of the heel.

You may not qualify if:

• Peripheral neuropathy.
• Tarsal tunnel syndrome (TTS) \\ Fat Pad Syndrome (FPS).
• Calcaneal cyst, Fracture or bone cancer.
• Osteo Arthritis (OA) of the foot fingers or Rheumatoid arthritis (RA).
• Foot surgery at the last year.
• Steroid injections at the last six months.
• Pregnancy.
• Foot infection or diabetic foot.
• Stress fractures of the heel.
• Unavailability in advance to participate in research.

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Maccabee Health Services Physical therapy Clinic

Rehovot, Southern District, Israel

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Ron Ben-izhak, PHD

  Maccabi Healthcare Services, Israel

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Double blinded RCT

Study Record Dates

• First Submitted: February 7, 2016
• First Posted: February 10, 2016
• Study Start: May 1, 2015
• Primary Completion: May 28, 2017
• Study Completion: May 28, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-01

Locations

IL (1)