Gluteus Medius Dry Needling and Ankle Instability
Primary Purpose
Chronic Instability of Joint, Trigger Point Pain, Myofascial
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Instability of Joint focused on measuring ankle, dry needling, trigger point
Eligibility Criteria
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.
Sites / Locations
- Fiom clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Individuals for this group will be treat with a dry needling intervention at the gluteus medius trigger point.
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).
Outcomes
Primary Outcome Measures
Pain intensity
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.
Pain pressure threshold
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
Secondary Outcome Measures
Range of motion
Assess the ankle range of motion with a goniometer.
Balance
Assess the lower limb balance with the star excursion balance test
Full Information
NCT ID
NCT04108390
First Posted
September 26, 2019
Last Updated
January 25, 2020
Sponsor
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04108390
Brief Title
Gluteus Medius Dry Needling and Ankle Instability
Official Title
Effectiveness of Gluteus Medius Dry Needling in Patients With Chronic Ankle Instability
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 25, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Instability of Joint, Trigger Point Pain, Myofascial
Keywords
ankle, dry needling, trigger point
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Individuals for this group will be treat with a dry needling intervention at the gluteus medius trigger point.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Dry needling
Other Intervention Name(s)
Manual Therapy
Intervention Description
For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
1 day
Title
Pain pressure threshold
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Range of motion
Description
Assess the ankle range of motion with a goniometer.
Time Frame
1 day
Title
Balance
Description
Assess the lower limb balance with the star excursion balance test
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fiom clinic
City
Madrid
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Gluteus Medius Dry Needling and Ankle Instability
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