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
Recruitment status was Not yet recruiting
Sponsor:
Réseau de Santé Vitalité Health Network
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
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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
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 May 16, 2013