- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108390
Gluteus Medius Dry Needling and Ankle Instability
Effectiveness of Gluteus Medius Dry Needling in Patients With Chronic Ankle Instability
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Madrid, Spain
- Fiom clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
Other Names:
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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).
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For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 1 day
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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.
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1 day
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Pain pressure threshold
Time Frame: 1 day
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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
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion
Time Frame: 1 day
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Assess the ankle range of motion with a goniometer.
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1 day
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Balance
Time Frame: 1 day
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Assess the lower limb balance with the star excursion balance test
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1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIPI/19/012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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