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How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients

Primary Purpose

Physical Therapy Modalities, Pain Measurement, Trigger Point Pain, Myofascial

Status
Terminated
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Treadmill exercise
Sponsored by
Becerra, Pablo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Therapy Modalities focused on measuring Humans, Excercise therapy, Hot temperature, Post dry needling, Range of motion, articular, Muscle Strength

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Complejo Hospitalario San Jose

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treadmill

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.
Ankle Range of Motion (ROM)
It is the degree of angular movement allowed by the ankle joint measured by kinovea.

Secondary Outcome Measures

Muscular strength of triceps sural
By means of the heel rise test, the patient must perform a bipodal plantiflexion measured in the maximum number of repetitions in 30 seconds.

Full Information

First Posted
January 3, 2022
Last Updated
January 15, 2022
Sponsor
Becerra, Pablo
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1. Study Identification

Unique Protocol Identification Number
NCT05193695
Brief Title
How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
Official Title
Heat or Excesice in Treadmill as Techique to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
full sample size
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Becerra, Pablo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy Modalities, Pain Measurement, Trigger Point Pain, Myofascial, Ankle Fractures, Rehabilitation, Needles
Keywords
Humans, Excercise therapy, Hot temperature, Post dry needling, Range of motion, articular, Muscle Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients remained in the supine position for 20 minutes lying on a stretcher after dry needling.
Arm Title
Treadmill
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Treadmill exercise
Other Intervention Name(s)
Treadmill after dry needling
Intervention Description
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)
Primary Outcome Measure Information:
Title
Perceived pain intensity
Description
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
Time Frame
Change from baseline (baseline and immediately after treatment)
Title
Ankle Range of Motion (ROM)
Description
It is the degree of angular movement allowed by the ankle joint measured by kinovea.
Time Frame
Change from baseline (baseline and immediately after treatment)
Secondary Outcome Measure Information:
Title
Muscular strength of triceps sural
Description
By means of the heel rise test, the patient must perform a bipodal plantiflexion measured in the maximum number of repetitions in 30 seconds.
Time Frame
Change from baseline (baseline and immediately after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Use of analgesics. Insurmountable fear of needles. Immune disease. Clotting disorders. Sensory disorders. Psychiatric / psychological illness. Cancer. Rheumatic diseases.
Facility Information:
Facility Name
Complejo Hospitalario San Jose
City
Santiago
ZIP/Postal Code
8380419
Country
Chile

12. IPD Sharing Statement

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How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients

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