Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 737 for:    Botulinum Toxins, Type A

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 15, 2017
Last Update Posted Date August 22, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03054610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.
Official Title  ICMJE Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.
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.

Detailed Description

Plantar fasciitis represents the most frequent cause of chronic heel pain, usually occurs in patients 40 years or older, overweight, sedentary or with intense physical activity.

The plantar fascia function is to prevent foot collapse by its anatomical orientation and by its tensile forces; It originates at the base of the calcaneus and extends distally to the phalanges. The plantar fascia stretching prevents the displacement of the calcaneus and the metatarsals and maintains the medial longitudinal arch. Simulates a cable attached to the calcaneus and metatarsophalangeal joints. The windlass mechanism described by Hicks, for the action of the plantar fascia is usually explained when a dorsiflexion of the fingers occurs, this leads to an effective shortening of the length of the plantar fascia causing an elevation of the arch. The extension of the fingers increases the arch of tension with the metatarsophalangeal joint as axis or anchor point. The shortening of the plantar fascia resulting from the dorsiflexion of the hallux is the essence of the windlass mechanism. When a fasciotomy is performed, this mechanism is lost, decreasing the stability of the arch and this does not allow a phase of stable terminal stay.

Historically the development of plantar fasciitis is attributed to biomechanical defects such as hyperpronation, this contributes to excesive mobility of the foot, which increases the stress applied to the musculofascial structures and soft tissue through an elongation of plantar fascia. There are other studies that have shown that one of the main factors for the appearance of this disease is the mechanical overload and it has been reported that the tension necessary for the rupture of the windlass mechanism ranges from 1.4 to 3.4 of the body weight of the subject.

There is a great variety of therapies reported for the treatment of this pathology, intralesional application of steroids, platelet-rich plasma, intralesional botulinum toxin A, treatments such as extracorporeal shock waves, all of which are assisted by stretching excercises of the gastrocnemius and sole muscles or stretching of the plantar fascia.

The clinical use of botulinum toxin A has expanded beyond the original indications by its effects on cholinergic neurons. The increased interest in the potential role to treat conditions of chronic pain is partially based on the effects of the toxin on the modulation of the release of substance P, on the calcitonin-related gene peptide and glutamate. On the other hand, the toxin has shown its effect on the inhibition of inflamatory pain and on the release of neurotransmitters from primary sensory neurons in a rat model. It also inhibits peripheral sensitization, which leads to an indirect decrease in central sensitization. It is unclear whether the treatment of chronic plantar fasciitis with botulinum toxin A works by causing muscle paralysis or by analgesic anti-inflamatory effects or by both mechanisms. A combined effect, induction of paresia of the muscles originating in the medial calcaneus process and direct analgesia due to analgesic anti-inflamatory properties.

We performed a previous study, where we compared the use of botulinum toxin A against intralesional steroids; The application of botulinum toxin A was performed in the twin and sole muscle wombs, while dexamethasone was applied in the area of greatest fascia pain. Patients who received botulinum toxin had a faster and more sustained improvement than patients who received steroids.

Another common form of treatment for plantar fasciitis is the application of intralesional steroids; however, there are reports of complications associated with these drugs and one of the main ones is the rupture of the plantar fascia, which ranges from 2.4% to 5.7% ; Despite pain relief due to rupture, many patients have other associated complications such as lateral plantar nerve dysfunction, stress fractures, among others, mainly after 2 applications.

Objective and originality: The aim of our study is to demonstrate that the use of botulinum toxin A for the treatment of plantar fasciitis is superior to treatment with intralesional steroids. We try to establish a safer and less painful treatment therapy for the patient, since the use of steroids is associated with complications. We believe that the botulinum toxin A can also be applied intralesional, since there is information that indicates that this toxin has analgesic and anti-inflammatory effect in its local application and not only by the action of muscle relaxation by blocking the release of acetylcholine at the neuromuscular junctions.

General objective:

To assess the therapeutic effect of botulinum toxin A in patients diagnosed with plantar fasciitis.

Hypothesis:

The application of botulinum toxin A presents better results in the treatment of plantar fascitis than the use of intralesional steroids.

Material and Methods:

All patients who are recruited for the study will be explained regarding the treatment protocol, and will also sign informed consent prior to inclusion in the study. Measurement of the plantar fascia using ultrasound and measurement of ranges of movement of ankle flexion, as well as measuring and weighing patients to know their body mass index. They will be randomized into one of three treatment groups. Group 1 (control) treatment with 5 ml of anesthetic (Ropivacaine 7.5%), Group 2 (steroids) application of 1ml of Betamethasone plus 3 ml of local anesthetic and Group 3 (botulinum toxin A) 250 U, in the insertion zone of the plantar fascia. All patients will receive a detailed explanation of the stretching exercises of the plantar fascia, as well as their frequency and duration. Afterwards, the patients will be evaluated by a blinded investigator, at 2 weeks, 1 month, 3 months and 6 months after infiltration; evaluation scales will be applied: Visual Analogue Scale (EVA), Maryland Foot & Ankle Score, Foot & Ankle Outcome Score (AOFAS), Foot & Ankle Disability Index (FADI).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Plantar Fascitis
  • Botulinum Toxins, Type A
Intervention  ICMJE
  • Drug: Betamethason Sodium Phosphate
    Other Name: Celestone Soluspan
  • Drug: Ropivacaine
    Other Name: Ropiconest
  • Drug: Botulinum Toxins, Type A
    Other Name: Dysport
Study Arms  ICMJE
  • Active Comparator: Control
    5 ml of local anesthetic (ropivacaine 7.5%)
    Intervention: Drug: Ropivacaine
  • Active Comparator: Steroid
    1ml of steroid Betamethason Sodium Phosphate (Celestone®) and local anesthetic (ropivacaine 7.5%)
    Interventions:
    • Drug: Betamethason Sodium Phosphate
    • Drug: Ropivacaine
  • Experimental: BTX-A
    200U Botulinum Toxins, Type A
    Intervention: Drug: Botulinum Toxins, Type A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Carlos Acosta-Olivo, MD, PhD 528183467798 dr.carlosacosta@gmail.com
Contact: Jorge Elizondo-Rodríguez, MD 528183467798 doctorelizondo@yahoo.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03054610
Other Study ID Numbers  ICMJE OR15-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
Study Sponsor  ICMJE Universidad Autonoma de Nuevo Leon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Acosta-Olivo, MD, PhD Universidad Autonoma de Nuevo Leon
PRS Account Universidad Autonoma de Nuevo Leon
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP