Prolotherapy for the Treatment of Plantar Fasciitis

NCT ID: NCT01326351

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Regenerative Injection Therapy

Group Type EXPERIMENTAL

Regenerative injection therapy

Intervention Type PROCEDURE

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

Group Type SHAM_COMPARATOR

Dry needle injection

Intervention Type PROCEDURE

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.

Exercise

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Réseau de Santé Vitalité Health Network

OTHER

Sponsor Role lead

Responsible Party

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Réseau de santé Vitalité Health Network

Locations

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Dr.-Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, Canada

Site Status

Countries

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Canada

Central Contacts

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Richard Dumais, MD

Role: CONTACT

506-862-4721

Facility Contacts

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Richard Dumais, MD

Role: primary

506-862-4721

Other Identifiers

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prolo-2011

Identifier Type: -

Identifier Source: org_study_id

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