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Efficacy of Dry Needling in Plantar Fasciitis

Efficacy of Dry Needling in Plantar Fasciitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467465
Enrollment
30
Registered
2015-06-10
Start date
2014-05-31
Completion date
2016-05-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasciitis, Plantar

Keywords

Fasciosis plantar, physiotherapy, fascitis plantar, dry needling

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

Interventions

OTHERPhysical therapy modalities

Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.

DEVICEInvasive Physical therapy modalities

Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.1 day.Plantar fascia thickness in millimeters with ultrasonography at 0,5 centimeters from the calcaneo bone. Mean of 3 measures was taken.

Secondary

MeasureTime frameDescription
Pain Assessment in the Affected Heel, by Visual Analog Scale.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.
Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.1 dayPain 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.
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.1 dayRange 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.
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.3 monthRange 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.
Goniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.1 dayRange 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.

Countries

Spain

Participant flow

Participants by arm

ArmCount
Physical Therapy Modalities
Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises. Physical therapy modalities: Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
15
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. Invasive Physical therapy modalities: Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles. Primary completion date is after January 2017.
15
Total30

Baseline characteristics

CharacteristicPhysical Therapy ModalitiesInvasive Physical Therapy ModalitiesTotal
Age, Continuous53.67 years
STANDARD_DEVIATION 11
49.47 years
STANDARD_DEVIATION 12.44
51.57 years
STANDARD_DEVIATION 11.73
Region of Enrollment
Spain
15 participants15 participants30 participants
Sex: Female, Male
Female
6 Participants4 Participants10 Participants
Sex: Female, Male
Male
9 Participants11 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

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.

Time frame: 6 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.4.4 millimeters
Invasive Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.3.9 millimeters
p-value: 0.466Wilcoxon (Mann-Whitney)
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.

Time frame: 3 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.4.6 millimeters
Invasive Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.4.0 millimeters
p-value: 0.25Wilcoxon (Mann-Whitney)
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.

Time frame: 1 day.

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.5.3 millimeters
Invasive Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.4.7 millimeters
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.

Time frame: 1 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.5.0 millimeters
Invasive Physical Therapy ModalitiesUltrasonographic Evaluation of the Thickness of the Affected Plantar Fascia, in Longitudinal View.4.2 millimeters
p-value: 0.175Wilcoxon (Mann-Whitney)
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.

Time frame: 1 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.101 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.104 degrees
p-value: 0.651t-test, 1 sided
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.

Time frame: 6 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.104 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.108 degrees
p-value: 0.755t-test, 1 sided
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.

Time frame: 1 day

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.95 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extended.99 degrees
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.

Time frame: 3 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.100 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Extened.104 degrees
p-value: 0.387t-test, 1 sided
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.

Time frame: 6 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.110 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.110 degrees
p-value: 0.279t-test, 1 sided
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.

Time frame: 1 day

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.104 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.109 degrees
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.

Time frame: 1 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.108 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.110 degrees
p-value: 0.032t-test, 1 sided
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.

Time frame: 3 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.109 degrees
Invasive Physical Therapy ModalitiesGoniometric Assessment of Joint Range of Motion Ankle Dorsiflexion With Knee Flexed.110 degrees
p-value: 0.058t-test, 1 sided
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.

Time frame: 1 day

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.7 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.7 units on a scale
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.

Time frame: 1 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.4 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.4 units on a scale
p-value: 0.849Wilcoxon (Mann-Whitney)
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.

Time frame: 3 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.0 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.1 units on a scale
p-value: 0.425Wilcoxon (Mann-Whitney)
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.

Time frame: 6 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.0 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.0 units on a scale
p-value: 0.487Wilcoxon (Mann-Whitney)
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.

Time frame: 1 day.

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.8 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.7 units on a scale
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.

Time frame: 6 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.0 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.0 units on a scale
p-value: 0.066Wilcoxon (Mann-Whitney)
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.

Time frame: 3 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.2 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.0 units on a scale
p-value: 0.275Wilcoxon (Mann-Whitney)
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.

Time frame: 1 month

ArmMeasureValue (MEDIAN)
Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.3 units on a scale
Invasive Physical Therapy ModalitiesPain Assessment in the Affected Heel, by Visual Analog Scale.2 units on a scale
p-value: 0.737Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026