Prolotherapy for the Treatment of Plantar Fasciitis
Primary Purpose
Plantar Fasciitis
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Regenerative injection therapy
Dry needle injection
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis
Eligibility 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
Sites / Locations
- Dr.-Georges-L.-Dumont University Hospital Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Regenerative Injection Therapy
Dry needle
Exercise
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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").
Full Information
NCT ID
NCT01326351
First Posted
March 29, 2011
Last Updated
April 18, 2011
Sponsor
Réseau de Santé Vitalité Health Network
1. Study Identification
Unique Protocol Identification Number
NCT01326351
Brief Title
Prolotherapy for the Treatment of Plantar Fasciitis
Official Title
Plantar Fasciitis: Pain Relief and Improvement of Foot Function With Prolotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Réseau de Santé Vitalité Health Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regenerative Injection Therapy
Arm Type
Experimental
Arm Title
Dry needle
Arm Type
Sham Comparator
Arm Title
Exercise
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Regenerative injection therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dry needle injection
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of pain and function of the affected foot during the course of treatment
Description
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.
Time Frame
Every 3 weeks from week 0 to 36
Secondary Outcome Measure Information:
Title
Assessment of pain intensity and pain-related function impairment during the course of treatment
Description
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").
Time Frame
Every 3 weeks from week 0 to 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Dumais, MD
Phone
506-862-4721
Email
rdumais72@gmail.com
Facility Information:
Facility Name
Dr.-Georges-L.-Dumont University Hospital Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 2Z3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Dumais, MD
Phone
506-862-4721
Email
rdumais72@gmail.com
First Name & Middle Initial & Last Name & Degree
Richard Dumais, MD
12. IPD Sharing Statement
Learn more about this trial
Prolotherapy for the Treatment of Plantar Fasciitis
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