NCT04108390

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

September 26, 2019

Last Update Submit

January 25, 2020

Conditions

Chronic Instability of JointTrigger Point Pain, Myofascial

Keywords

ankledry needlingtrigger point

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Range of motion

    1 day

  • Balance

    1 day

Study Arms (2)

Intervention group

EXPERIMENTAL

Individuals for this group will be treat with a dry needling intervention at the gluteus medius trigger point.

Other: Dry needling

Control group

ACTIVE COMPARATOR

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).

Other: Dry needling

Interventions

Dry needlingOTHER

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

Also known as: Manual Therapy
Control groupIntervention group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fiom clinic

Madrid, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry NeedlingMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 30, 2019

Study Start

September 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 25, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

Locations

ES(1)