Efficacy of Dry Needling in Plantar Fasciitis

August 25, 2020 updated by: Miguel Suárez Varela, Universidad Complutense de Madrid
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Clínica Universitaria de podología de la Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical therapy modalities
Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.
Other: Physical therapy modalities
Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
Experimental: Invasive Physical therapy modalities
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time Frame: 1 day.
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
1 day.
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time Frame: 1 month
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
1 month
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time Frame: 3 month
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
3 month
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.
Time Frame: 6 month
Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time Frame: 1 day.
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.
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time Frame: 1 month
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
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time Frame: 3 month
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
Pain Assessment in the Affected Heel, by Visual Analog Scale.
Time Frame: 6 month
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
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time Frame: 1 day
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
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time Frame: 1 month
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
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time Frame: 3 month
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
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.
Time Frame: 6 month
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Time Frame: 1 day
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Time Frame: 1 month
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.
Time Frame: 3 month
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.
Time Frame: 6 month
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time Frame: 1 day
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time Frame: 1 month
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time Frame: 3 month
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
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.
Time Frame: 6 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Complutense de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suárez Miguel, Physician, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Univ. Complutense de Madrid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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