Efficacy of Dry Needling in Plantar Fasciitis

Fasciitis, Plantar Clinical Trial

Official title:

Efficacy of Dry Needling in Plantar Fasciitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467465
• Other study ID #: Univ. Complutense de Madrid
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2020
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Other:
• Physical therapy modalities
Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.

Device:
• Invasive Physical therapy modalities
Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.

Locations

Country	Name	City	State
Spain	Clínica Universitaria de Podología de la Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.	1 day.
Primary	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.	1 month
Primary	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.	3 month
Primary	Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.	Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.	6 month
Secondary	Pain Assessment in the Affected Heel, by Visual Analog Scale.	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	1 day.
Secondary	Pain Assessment in the Affected Heel, by Visual Analog Scale.	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	1 month
Secondary	Pain Assessment in the Affected Heel, by Visual Analog Scale.	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	3 month
Secondary	Pain Assessment in the Affected Heel, by Visual Analog Scale.	First step pain measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	6 month
Secondary	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	1 day
Secondary	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	1 month
Secondary	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	3 month
Secondary	Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.	Pain after long periods of rest measured by Visual Analogue Scale, from 0 to 10 points, in the affected heel. In the Visual Analogue Scale, 0 represents the lowest score and 10 represents the highest score when the patient felt the maximum level of pain.	6 month
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	1 day
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values.Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	1 month
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	3 month
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.	Range of motion of ankle dorsiflexion with knee extended measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	6 month
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	1 day
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	1 month
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	3 month
Secondary	Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.	Range of motion of ankle dorsiflexion with knee flexed 90º measured in grades using a goniometer. There is not exist minimum and maximum scores for the goniometric assessment, because the limits of the range of motion depends on the joint mobility, then, for this measure, higher values are better results than lower values. Clinically, it means that one patient with 100 degrees of range of motion has more mobility than another with 90 degrees.	6 month