Prolotherapy for the Treatment of Plantar Fasciitis

Study Overview
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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.

Official Title
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Plantar Fasciitis: Pain Relief and Improvement of Foot Function With Prolotherapy

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Procedure: Regenerative injection therapy
* Procedure: Dry needle injection
* Behavioral: Exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regenerative Injection Therapy<br> | Procedure: Regenerative injection therapy<br>* 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.<br>|
| Sham Comparator: Dry needle<br> | Procedure: Dry needle injection<br>* 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.<br>|
| Active Comparator: Exercise<br> | Behavioral: Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain intensity and pain-related function impairment during the course of treatment | 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). | Every 3 weeks from week 0 to 36 |