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Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.

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ClinicalTrials.gov Identifier: NCT03054610
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Brief Summary:

Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in people 40 years of age or older, overweight, sedentary or with intense physical activity. It is caused by the over-stretching of the plantar fascia, which is a band of connective tissue that extends to the base of the phalanges. This produces micro-tears more commonly in its origin in the medial tuberosity of the calcaneus which causes an inflammatory process and pain. This pain usually occurs when the person gets up in the morning after sleeping or after sitting for a long time. That is when the fascia is stretched after being in a contraction position.

There are a great variety of treatments for this pathology, of these, one of the most common is the use of intralesional steroids, which a weighing that reduces symptomatology in many cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are extracorporeal shock waves, application of platelet-rich plasma and application of botulinum toxin A intralesional. All of them are accompanied by insoles, night splints and stretching exercises of the Achilles tendon and the plantar fascia.

Recent studies have shown that the application of botulinum toxin A intralesional in patients with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity and presentation time. Decreased inflammation of the plantar fascia has also been demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is applied regularly in the muscles to block the release of acetylcholine in the neuromuscular plaque and obtain its relaxation and not directly in the pain points. We believe that the botulinum toxin can be applied intralesional currently, since there is information that the toxin has analgesic and anti-inflammatory effect and not just muscle relaxation.

The aim of our work demonstrate that the use of botulinum toxin A and intralesional stretching exercises is superior to intralesional steroids and stretching trying to establish a safer and less painful therapy avoiding complications prior to the application of steroid application.


Condition or disease Intervention/treatment Phase
Plantar Fascitis Botulinum Toxins, Type A Drug: Betamethason Sodium Phosphate Drug: Ropivacaine Drug: Botulinum Toxins, Type A Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Active Comparator: Control
5 ml of local anesthetic (ropivacaine 7.5%)
Drug: Ropivacaine
Other Name: Ropiconest

Active Comparator: Steroid
1ml of steroid Betamethason Sodium Phosphate (Celestone®) and local anesthetic (ropivacaine 7.5%)
Drug: Betamethason Sodium Phosphate
Other Name: Celestone Soluspan

Drug: Ropivacaine
Other Name: Ropiconest

Experimental: BTX-A
200U Botulinum Toxins, Type A
Drug: Botulinum Toxins, Type A
Other Name: Dysport




Primary Outcome Measures :
  1. Foot and Ankle Disability Index [ Time Frame: 6 months ]
    We decided to include the FADI score because this type of pathology occurs in patients with sports activity and often causes disability in them, Values activities such as standing, walking on flat or uneven surfaces, inclined planes, time without discomfort while walking, and includes a module where sports activities are valued. Also it counts on an evaluation of the pain in foot and ankle. The best result obtained is 136 points.


Secondary Outcome Measures :
  1. Maryland Foot Score [ Time Frame: 6 months ]
    Is divided into several sections where pain is assessed, giving 45 points when there is no pain and 0 when there is inability to work, a function that is divided into two sections, walking and daily activities; And a section that evaluates the shape of the foot, the best score is 100, which means that there is no problem with the foot, and the lowest score is 0.

  2. Ankle-Hindfoot Scale [ Time Frame: 6 months ]
    American Foot and Ankle Orthopedic Society

  3. Visual Analogue scale [ Time Frame: 6 months ]
    Values the pain on a numerical scale of 0-10, where 0 means no pain and 10 greater degree of pain experienced by the patient, it is also complemented by a color scale, where green is equal to painless and red is the more intense pain the patient has had.

  4. Measurement of the plantar fascia using ultrasound [ Time Frame: 6 months ]
    Measure the thickness of the plantar fascia at the beginning and end of the protocol, placing the transducer at the insertion site of the plantar fascia.

  5. Body Mass Index [ Time Frame: 15 minutes ]
    Measure height and weight of patients at the beginning of the protocol.

  6. Measure degrees of dorsiflexion [ Time Frame: 6 months ]
    Use a goniometer as a tool to measure degrees of dorsiflexion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with chronic pain in the heel at the insertion of the plantar fascia in the posteroinferior tuberosity of the calcaneus.
  • Patients who agreed to be part of the study and signed informed consent.
  • Patients older than 18 years.
  • Patients with two or more weeks of evolution.

Exclusion Criteria:

  • Patients with another associated pathology such as knee or ankle dysfunction, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, etc.
  • Neurological abnormalities: mental retardation or some psychiatric abnormality.
  • Pregnant patients.
  • Previous surgery on the heel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054610


Contacts
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Contact: Carlos Acosta-Olivo, MD, PhD 528183467798 dr.carlosacosta@gmail.com
Contact: Jorge Elizondo-Rodríguez, MD 528183467798 doctorelizondo@yahoo.com

Locations
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Mexico
Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Carlos Acosta-Olivo, MD, PhD    528183467798    dr.carlosacosta@gmail.com   
Contact: Jorge Elizondo-Rodríguez, MD    528183467798    doctorelizondo@yahoo.com   
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Carlos Acosta-Olivo, MD, PhD Universidad Autonoma de Nuevo Leon

Additional Information:
Publications:

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Responsible Party: Carlos A Acosta-Olivo, Principal Investigator, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03054610     History of Changes
Other Study ID Numbers: OR15-001
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
plantar fascitis
Botulinum toxin A
Betamethason Sodium Phosphate
infiltration
plantar fascia

Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Ropivacaine
Betamethasone acetate phosphate
Botulinum Toxins, Type A
Botulinum Toxins
abobotulinumtoxinA
Betamethasone sodium phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Neuromuscular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists