Plantar Fasciitis
Conditions
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.
Interventions
PROCEDURERegenerative 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.
PROCEDUREDry 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.
BEHAVIORALExercise
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.
Sponsors
Réseau de Santé Vitalité Health Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Contacts
Primary ContactRichard Dumais, MD
Outcome results
None listed