NCT05193695

Brief Summary

Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. This generates disuse and atrophy of the posterior musculature of the leg called the triceps sural, which makes it difficult to restart and perform the gait. We conducted this research because practically all patients with this type of diagnosis have trigger points in these muscles, and dry needling technique is one of the best for its treatment, but has the disadvantage that it produces post dry needling pain of 48 hours and there is not enough information, or consensus on which method is better to reduce post dry needling pain. This study aims to prove wich technique is most useful in reducing pain post dry needling for the treatment of trigger points in the triceps sural muscle in ankle post fracture patients.

Trial Health

57
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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

January 3, 2022

Last Update Submit

January 15, 2022

Conditions

Physical Therapy ModalitiesPain MeasurementTrigger Point Pain, MyofascialAnkle FracturesRehabilitationNeedles

Keywords

HumansExcercise therapyHot temperaturePost dry needlingRange of motion, articularMuscle Strength

Outcome Measures

Primary Outcomes (2)

  • Perceived pain intensity

    Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.

    Change from baseline (baseline and immediately after treatment)

  • Ankle Range of Motion (ROM)

    It is the degree of angular movement allowed by the ankle joint measured by kinovea.

    Change from baseline (baseline and immediately after treatment)

Secondary Outcomes (1)

  • Muscular strength of triceps sural

    Change from baseline (baseline and immediately after treatment)

Study Arms (2)

Control

NO INTERVENTION

Patients remained in the supine position for 20 minutes lying on a stretcher after dry needling.

Treadmill

EXPERIMENTAL

The patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002).

Other: Treadmill exercise

Interventions

Treadmill exerciseOTHER

the patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002)

Also known as: Treadmill after dry needling
Treadmill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages between 18 and 60 years of age.
  • Man or woman.
  • At least one trigger point, active or latent, in the triceps sural muscle of the fractured ankle.
  • Perform full load without using technical aids.

You may not qualify if:

  • Use of analgesics.
  • Insurmountable fear of needles.
  • Immune disease.
  • Clotting disorders.
  • Sensory disorders.
  • Psychiatric / psychological illness.
  • Cancer.
  • Rheumatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario San Jose

Santiago, 8380419, Chile

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesAnkle Fractures

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesFractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 18, 2022

Study Start

August 9, 2018

Primary Completion

April 4, 2019

Study Completion

April 30, 2019

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

CL(1)