Gluteus Medius Dry Needling and Ankle Instability

January 25, 2020 updated by: Carlos Romero Morales, Universidad Europea de Madrid

Effectiveness of Gluteus Medius Dry Needling in Patients With Chronic Ankle Instability

Randomized clinical trial in individuals with chronic ankle instability. Main outcomes were as follows: pain intensity, pressure pain threshold, lower limb balance and range of motion. The sample will be divided in two groups: 1) dry needling at the gluteus medius trigger point (intervention). 2) dry needling 1,5 cm from the gluteus medius trigger point (control).

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Inclusion criteria will be: individuals with chronic ankle instability, 20 to 50 years old. Exclusion criteria: any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.

Initially, the base measurements were as follows: paint intensity, pressure pain threshold at the gluteus medius trigger point, ankle range of motion and balance of the lower limb.

Once baseline measurements will be taken, the same evaluations will be performed at 4 weeks from the start.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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

      • Madrid, Spain
        • Fiom clinic

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

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • individuals with chronic ankle instability, 20 to 50 years old.

Exclusion Criteria:

  • any lower limb disease, fractures, infections, pregnancy, received any treatment in the previous 3 months.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Individuals for this group will be treat with a dry needling intervention at the gluteus medius trigger point.
For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
Other Names:
  • Manual Therapy
Active Comparator: Control group
Individuals for this group will be treat with a dry needling technique at 1,5 cm from the trigger point (not in the trigger point).
For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
Other Names:
  • Manual Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 1 day
Individuals reported the pain intensity with the Visual Analogue Scale (VAS scale). The minimum and maximum scores were 0 (no pain) 100 (the worst pain). There was no sub-scales.
1 day
Pain pressure threshold
Time Frame: 1 day
Pain pressure threshold were recorded with a pressure algometer. Evaluator press the trigger point with the algometer until the patient feel pain. The outcome will be recorder and expressed in kg/cm2
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion
Time Frame: 1 day
Assess the ankle range of motion with a goniometer.
1 day
Balance
Time Frame: 1 day
Assess the lower limb balance with the star excursion balance test
1 day

Collaborators and Investigators

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

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 (Actual)

September 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Anticipated)

March 25, 2020

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 25, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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