Prolotherapy for the Treatment of Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01326351
• Other study ID #: prolo-2011
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: April 18, 2011
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2011
• Source: Réseau de Santé Vitalité Health Network
• Contact: Richard Dumais, MD
• Phone: 506-862-4721
• Email: rdumais72[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Canada	Dr.-Georges-L.-Dumont University Hospital Centre	Moncton	New Brunswick

Sponsors (1)

Lead Sponsor	Collaborator
Réseau de Santé Vitalité Health Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes