Prolotherapy for the Treatment of Plantar Fasciitis

Plantar Fasciitis: Pain Relief and Improvement of Foot Function With Prolotherapy

The purpose of this study is to demonstrate that prolotherapy in conjunction with a physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia, relieves pain and improves function of people suffering of plantar fasciitis, an inflammation of the plantar fascia, after basic treatment failure.

Study Overview

• Status: Unknown
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Procedure: Regenerative injection therapy; Procedure: Dry needle injection; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Richard Dumais, MD; Phone Number: 506-862-4721; Email: rdumais72@gmail.com

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Dr.-Georges-L.-Dumont University Hospital Centre
      • Contact: Richard Dumais, MD; Phone Number: 506-862-4721; Email: rdumais72@gmail.com
      • Principal Investigator: Richard Dumais, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• have a diagnosis of Plantar Fasciitis
• experience pain in the plantar fascia for more than 6 months
• be capable to understand and execute physiotherapy exercises

Exclusion Criteria:

• previous operation of the plantar fascia
• deformation of the foot (congenital or acquired)
• presence or suspicion of infection of the skin at the site where the injection will occur
• history of systemic diseases capable of inducing pain or sensitivity to the feet (seronegative arthritis, diabetes, fibromyalgia, etc.)
• abnormal coagulation
• allergy to lidocaine and/or marcaine
• pregnancy
• lumbar, hip or knee pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise	Behavioral: Exercise; At-home exercise program that patients must perform 3 times a week for a total of 12 weeks. The exercise program consists of 3 stretching exercises, 1 muscle release exercise and 1 strengthening exercise.
Experimental: Regenerative Injection Therapy	Procedure: Regenerative injection therapy; Injection of 10cc of a 15% dextrose and 0.6% lidocaine solution free of epinephrine in one injection site (lateral infiltration of the plantar fascia). This injection will be performed following posterior tibial nerve blockade (injection of 10cc of 1% lidocaine and 0.25% bupivacaine solution free of epinephrine behind the posterior tibial artery). The intervention will be administered every three weeks until symptoms are alleviated for a maximum of 5 injection sessions. Furthermore, patients must perform an at-home exercise program 3 times a week for a total of 12 weeks. The exercise program consists of 3 stretching exercises, 1 muscle release exercise and 1 strengthening exercise.
Sham Comparator: Dry needle	Procedure: Dry needle injection; Injection of dry needle in one injection site (lateral infiltration of the plantar fascia). This injection will be performed following posterior tibial nerve blockade(injection of 10cc of 1% lidocaine and 0.25% bupivacaine solution free of epinephrine behind the posterior tibial artery). The intervention will be administered every three weeks until symptoms are alleviated for a maximum of 5 injection sessions. Furthermore, patients must perform an at-home exercise program 3 times a week for a total of 12 weeks. The exercise program consists of 3 stretching exercises, 1 muscle release exercise and 1 strengthening exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain and function of the affected foot during the course of treatment	The Maryland Foot Score questionnaire will be used. This questionnaire assesses pain and function of injured foot using a summated rating scale of 10 questions.	Every 3 weeks from week 0 to 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain intensity and pain-related function impairment during the course of treatment	The Brief Pain Inventory (short form) will be administered to assess pain intensity and pain-related functional impairment (physical and emotional). Four items assess the intensity of current pain and pain at ils least, worst, and average during the past day on scales form 0 ("no pain") to 10 ("pain as bad as you can imagine"). Seven more items measure pain-related functional interference in different domains (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) rated from 0 ("does not interfere") to 10 ("interferes completely").	Every 3 weeks from week 0 to 36

Collaborators and Investigators

• Sponsor: Réseau de Santé Vitalité Health Network

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 18, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: prolo-2011