Prolotherapy for the Treatment of Plantar Fasciitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Réseau de Santé Vitalité Health Network.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Réseau de Santé Vitalité Health Network
ClinicalTrials.gov Identifier:
NCT01326351
First received: March 29, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Plantar Fasciitis
Procedure: Regenerative injection therapy
Procedure: Dry needle injection
Behavioral: Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plantar Fasciitis: Pain Relief and Improvement of Foot Function With Prolotherapy

Resource links provided by NLM:


Further study details as provided by Réseau de Santé Vitalité Health Network:

Primary Outcome Measures:
  • Assessment of pain and function of the affected foot during the course of treatment [ Time Frame: Every 3 weeks from week 0 to 36 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Assessment of pain intensity and pain-related function impairment during the course of treatment [ Time Frame: Every 3 weeks from week 0 to 36 ] [ Designated as safety issue: Yes ]
    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").


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326351

Contacts
Contact: Richard Dumais, MD 506-862-4721 rdumais72@gmail.com

Locations
Canada, New Brunswick
Dr.-Georges-L.-Dumont University Hospital Centre Not yet recruiting
Moncton, New Brunswick, Canada, E1C 2Z3
Contact: Richard Dumais, MD    506-862-4721    rdumais72@gmail.com   
Principal Investigator: Richard Dumais, MD         
Sponsors and Collaborators
Réseau de Santé Vitalité Health Network
  More Information

No publications provided

Responsible Party: Dr. Richard Dumais/ Professor, Pain Clinic Director, Anesthetist and Chronic Pain Specialist, Réseau de santé Vitalité Health Network
ClinicalTrials.gov Identifier: NCT01326351     History of Changes
Other Study ID Numbers: prolo-2011
Study First Received: March 29, 2011
Last Updated: April 18, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on October 01, 2014