Clinical trial NCT02467465: Efficacy of Dry Needling in Plantar Fasciitis
Official title: Efficacy of Dry Needling in Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar
Keywords: Fasciosis plantar
physiotherapy
fascitis plantar
dry needling
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
timeFrame: 1 day.
measure: Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
timeFrame: 1 month
measure: Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
timeFrame: 3 month
measure: Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
timeFrame: 6 month
Secondary outcomes:
measure: Pain Assessment in the Affected Heel, by Visual Analog Scale.
timeFrame: 1 day.
measure: Pain Assessment in the Affected Heel, by Visual Analog Scale.
timeFrame: 1 month
measure: Pain Assessment in the Affected Heel, by Visual Analog Scale.
timeFrame: 3 month
measure: Pain Assessment in the Affected Heel, by Visual Analog Scale.
timeFrame: 6 month
measure: Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
timeFrame: 1 day
measure: Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
timeFrame: 1 month
measure: Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
timeFrame: 3 month
measure: Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
timeFrame: 6 month
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
timeFrame: 1 day
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
timeFrame: 1 month
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.
timeFrame: 3 month
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
timeFrame: 6 month
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
timeFrame: 1 day
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
timeFrame: 1 month
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
timeFrame: 3 month
measure: Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
timeFrame: 6 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Study officials:
affiliation: Principal Investigator
name: Suárez Miguel, Physician
role: PRINCIPAL_INVESTIGATOR
References: