Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Incobotulinum Toxin A: will be administered 2 ampoules (200 IU) of Incobotulinum toxin , injectable solution presentation 100 IU ampoule with powder diluted in 1 ml of 0.9% saline solution in a single application at 4 points, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).

Glucocorticoid: Program in which 2 ml of dexamethasone will be administered in an 8 mg/2 ml ampoule diluted in 2 ml of lidocaine injectable solution in a 50 ml bottle (20 mg/ml) in a single application at 1 point, in addition to a therapeutic exercise program in the teaching service to later do it at home that will be done daily for 4 months (cryotherapy for 15 minutes on the plantar fascia, active mobilizations of the ankle and foot for 5 minutes, stretching exercises for the triceps surae and plantar fascia for 20 seconds, 3 repetitions, strengthening of intrinsic muscles of the foot).

Study summary

Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis .

Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: GROUP A: Patients who accept intralesional infiltration with incobotulinum toxin . GROUP B: Patients who accept intralesional infiltration with dexamethasone.

Both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. The visual analogue scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Foot and Ankle Disability Index (FADI) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p \<0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.

Eligibility

Primary outcome measure(s)

• Visual Analogue Pain Scale — Initially, 4, 8 and 16 weeks.
  zero is equivalent to no pain and 10 indicates the worst possible pain
• Clinical Functional Status of the Ankle and Foot — Initially, 4, 8 and 16 weeks.
  Result of the total summative score of the American Foot and Ankle Society Scale, Excellent=90-100, Good =80-89, Medium=70-79, Poor=\<70.
• Index of Functional Disability of the Foot and Ankle in Activities of Daily Living — Initially, 4, 8 and 16 weeks.
  Result of the total summative score of the Ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0
• Index of Functional Disability of the Foot and Ankle in Sports Activities — Initially, 4, 8 and 16 weeks.
  Result of the total summative score of the ankle disability index scale. Absence of disability or pain = 100 Mild=80-99 Moderate=50-79 Severe:1-49 Maximum disability level = 0

Trial sites (1)

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