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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 curre

Detailed Summary:

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.

Sponsor: Universidad Autonoma de Nuevo Leon

Current Primary Outcome: Foot and Ankle Disability Index [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: Universidad Autonoma de Nuevo Leon

Dates:
Date Received: February 13, 2017
Date Started: January 2015
Date Completion: December 2018
Last Updated: February 15, 2017
Last Verified: February 2017