NCT02467465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

September 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

May 27, 2015

Results QC Date

March 17, 2020

Last Update Submit

August 25, 2020

Conditions

Keywords

Fasciosis plantarphysiotherapyfascitis plantardry needling

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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

  • 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

  • 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 Outcomes (16)

  • Pain Assessment in the Affected Heel, by Visual Analog Scale.

    1 day.

  • Pain Assessment in the Affected Heel, by Visual Analog Scale.

    1 month

  • Pain Assessment in the Affected Heel, by Visual Analog Scale.

    3 month

  • Pain Assessment in the Affected Heel, by Visual Analog Scale.

    6 month

  • Pain Assessment in the Affected Heel After Long Periods of Rest, by Visual Analog Scale.

    1 day

  • +11 more secondary outcomes

Study Arms (2)

Physical therapy modalities

EXPERIMENTAL

Manual therapy techniques aimed to relaxed gastrocnemius and soleus muscles tone, movilizations, stretching and home exercises.

Other: Physical therapy modalities

Invasive Physical therapy modalities

EXPERIMENTAL

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 modalitiesDevice: Invasive Physical therapy modalities

Interventions

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

Invasive Physical therapy modalitiesPhysical therapy modalities

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

Invasive Physical therapy modalities

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Results Point of Contact

Title
Miguel Suárez Varela
Organization
Universidad Complutense de Madrid

Study Officials

  • Suárez Miguel, Physician

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy degree

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 10, 2015

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

September 9, 2020

Results First Posted

August 18, 2020

Record last verified: 2020-07

Locations