Efficacy of Dry Needling in Plantar Fasciitis

U

Universidad Complutense de Madrid

Status

Completed

Conditions

Fasciitis, Plantar

Treatments

Other: Physical therapy modalities
Device: Invasive Physical therapy modalities

Study type

Interventional

Funder types

Other

Identifiers

NCT02467465
Univ. Complutense de Madrid

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion 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.

Exclusion criteria

  • Presence of neoplastic disease.
  • Presence 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Physical therapy modalities
Experimental group
Description:
Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.
Treatment:
Other: Physical therapy modalities
Invasive Physical therapy modalities
Experimental group
Description:
Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Previously, DN will be applied in gastrocnemius and soleus muscles.
Treatment:
Device: Invasive Physical therapy modalities
Other: Physical therapy modalities

Trial documents
3

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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