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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04108390
Other study ID # CIPI/19/012
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 25, 2020

Study information

Verified date January 2020
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date March 25, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

Other:
Dry needling
For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.

Locations

Country Name City State
Spain Fiom clinic Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Primary 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 1 day
Secondary Range of motion Assess the ankle range of motion with a goniometer. 1 day
Secondary Balance Assess the lower limb balance with the star excursion balance test 1 day
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