NCT01326351

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

9 months

First QC Date

March 29, 2011

Last Update Submit

April 18, 2011

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Every 3 weeks from week 0 to 36

Secondary Outcomes (1)

  • Assessment of pain intensity and pain-related function impairment during the course of treatment

    Every 3 weeks from week 0 to 36

Study Arms (3)

Regenerative Injection Therapy

EXPERIMENTAL
Procedure: Regenerative injection therapy

Dry needle

SHAM COMPARATOR
Procedure: Dry needle injection

Exercise

ACTIVE COMPARATOR
Behavioral: Exercise

Interventions

Regenerative injection therapyPROCEDURE

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.

Regenerative Injection Therapy
Dry needle injectionPROCEDURE

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.

Dry needle
ExerciseBEHAVIORAL

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.

Exercise

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moncton, New Brunswick, E1C 2Z3, Canada

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Exercise

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Richard Dumais, MD

CONTACT

506-862-4721rdumais72@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

March 30, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 19, 2011

Record last verified: 2011-04

Locations

CA(1)