Efficacy of Dry Needling in Plantar Fasciitis
Condition: Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      The plantar fasciitis (PF) is the most common cause of pain on the underside of the heel.
      About 10% to 20% of the population suffer once during their lifetime. PF concept began to
      describe at the end of XX century through the discovery of new clinical and histopathological
      signs of the plantar fascia. The difficulty of diagnosis, understanding and treatment of PF
      require us to develop new treatment avenues to improve the approach and the understanding of
      it. Dry needling (DN) as a treatment of myofascial pain syndrome (MPS) and myofascial trigger
      points (MTP) of muscle associated with the pathology, it may be a good treatment strategy, as
      demonstrated in the treatment of MPS in other body regions such as the neck, shoulder or the
      lumbar spine.
    

Detailed description: 
      Hypothesis:

      Add dry needling to a physiotherapy intervention, increases the efficacy of treatment for
      plantar fasciosis.

      Objectives:

      General:

      Test the efficacy of DN in addition to physiotherapy treatment includes: manual therapy and
      home exercises; directed to normalize muscle tone and inhibit MTP of the gastrocnemius and
      soleus muscles, in a group of patients who have been diagnosed with PF.

      The variables to measure the efficacy are:

      Pain assessment in the affected heel, by visual analog scale (VAS). Ultrasonographic
      assessment of the thickness of the plantar fascia affected, in longitudinal view, compared
      with the contralateral.

      Goniometric assessment of joint range of ankle dorsiflexion, compared with the contralateral.

      Specific:

      Analyze the efficacy of the combination of DN treatment with manual therapy and home
      exercise, in patients who have been diagnosed with PF through monitoring and comparison
      between groups.

      Methodology:

      Type of study: clinical trial.

      Sample:

      It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of
      0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the
      second to detect a difference equal to or greater than 0.6 units. It is assumed that the
      common standard deviation is 0.57. It has been estimated loss rate of 0%.

      population: patients with a confirmed diagnosis of PF, who agree to participate in the study
      after signing the informed consent and carry out the selection criteria.

      Sample:

      It has been used sample size calculator GRANMO version 7.12, and accepting an alpha risk of
      0.05 and a beta risk of 0.2, 15 subjects were required in the first group and 15 in the
      second to detect a difference equal to or greater than 0.6 units. It is assumed that the
      common standard deviation is 0.57. It has been estimated loss rate of 0%.

      Selection criteria:

      Ultrasonographic study in which a proximal thickened affected plantar fascia is observed
      greater than or equal to 4 mm.

      Pain fell to the first steps in the morning. Pain with palpation at the insertion of the
      medial calcaneal tubercle, above 5, in a 10-point VAS.

      Pathology time evolution of greater than or equal to 4 weeks. Age of patients over 18 years.
      Acceptance by the patient to participate in the study, having signed the informed consent.

      Absence of neoplastic disease. Absence of neurological, sensory, orthopedic and / or surgical
      alterations. The patient is already doing treatment of physical medicine and rehabilitation.
      Be subjected to antiplatelet drug therapy. Fear of needles (needle phobia). Difficulty for
      the patient to understand the instructions to be followed during the study.

      Methods of collecting information:

      Personal data for each patient and relevant to the study, collected in a protocolized
      questionnaire, as well as an Excel sheet. All this in a personal history, encoded according
      to a table of alphanumeric equivalents, allowing subsequent statistical analysis with
      SPSS19.0 program.

      Statistical method:

      Initially, a descriptive statistical analysis will be conducted: qualitative variables were
      summarized by frequency distribution and quantitative by its average and standard deviation.
      Also it summarizes the information graphically using box plots, bar charts and pie charts.

      Furthermore an inferential analysis using parametric or non-parametric techniques,
      particularly for the main objective analysis of variance was used in two groups (assuming a
      normal distribution for the variable response) U test or Mann-Whitney will be made in the
      case lack of normal. To study the response variables in each test group the Student t test or
      unimuestral averages Wilcoxon signed ranks for related samples was used.

      For the analysis of qualitative variables the test of Chi-square test and the association
      between quantitative variables will be analyzed using the Pearson correlation coefficients
      and Spearman.

      To test these significant differences in values of p <0.05 was assumed. Statistical analysis
      was performed using the statistical software SPSS v19.0
    

Intervention name(s): Physical therapy modalities; Invasive Physical therapy modalities
Intervention type(s): Other; Device
Intervention description(s): Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.; Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fasciosis plantar; physiotherapy; fascitis plantar; dry needling