Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.
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| ClinicalTrials.gov Identifier: NCT03054610 |
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Recruitment Status :
Recruiting
First Posted : February 15, 2017
Last Update Posted : August 22, 2019
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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
| 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 |
|---|---|
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Active Comparator: Control
5 ml of local anesthetic (ropivacaine 7.5%)
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Drug: Ropivacaine
Other Name: Ropiconest |
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Active Comparator: Steroid
1ml of steroid Betamethason Sodium Phosphate (Celestone®) and local anesthetic (ropivacaine 7.5%)
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Drug: Betamethason Sodium Phosphate
Other Name: Celestone Soluspan Drug: Ropivacaine Other Name: Ropiconest |
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Experimental: BTX-A
200U Botulinum Toxins, Type A
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Drug: Botulinum Toxins, Type A
Other Name: Dysport |
- 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.
- 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.
- Ankle-Hindfoot Scale [ Time Frame: 6 months ]American Foot and Ankle Orthopedic Society
- 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.
- 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.
- Body Mass Index [ Time Frame: 15 minutes ]Measure height and weight of patients at the beginning of the protocol.
- 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 |
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.
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
| Contact: Carlos Acosta-Olivo, MD, PhD | 528183467798 | dr.carlosacosta@gmail.com | |
| Contact: Jorge Elizondo-Rodríguez, MD | 528183467798 | doctorelizondo@yahoo.com |
| 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 | |
| Principal Investigator: | Carlos Acosta-Olivo, MD, PhD | Universidad Autonoma de Nuevo Leon |
Additional Information:
Publications:
| 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:
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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 |