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Prolotherapy for the Treatment of Plantar Fasciitis

R

Réseau de Santé Vitalité Health Network

Status and phase

Unknown
Phase 4

Conditions

Plantar Fasciitis

Treatments

Behavioral: Exercise
Procedure: Dry needle injection
Procedure: Regenerative injection therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01326351
prolo-2011

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Regenerative Injection Therapy
Experimental group
Treatment:
Procedure: Regenerative injection therapy
Dry needle
Sham Comparator group
Treatment:
Procedure: Dry needle injection
Exercise
Active Comparator group
Treatment:
Behavioral: Exercise

Trial contacts and locations

1

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Central trial contact

Richard Dumais, MD

Data sourced from clinicaltrials.gov

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