Prolotherapy for the Treatment of Plantar Fasciitis

Phase 4

• Conditions: Plantar Fasciitis
• Interventions: Procedure: Regenerative injection therapy; Procedure: Dry needle injection; Behavioral: Exercise

• Registration Number: NCT01326351
• Lead Sponsor: Réseau de Santé Vitalité Health Network

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-19
• Study Start: 2011-05
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regenerative Injection Therapy	Regenerative injection therapy	-
Dry needle	Dry needle injection	-
Exercise	Exercise	-

Primary Outcome Measures

Name	Time	Method
Assessment of pain and function of the affected foot during the course of treatment	Every 3 weeks from week 0 to 36	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

Name	Time	Method
Assessment of pain intensity and pain-related function impairment during the course of treatment	Every 3 weeks from week 0 to 36	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").

Trial Locations

Locations (1)

Dr.-Georges-L.-Dumont University Hospital Centre; 🇨🇦 Moncton, New Brunswick, Canada