Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery

January 22, 2019 updated by: Carlos Cruz Montecinos, Hospital San José, Chile
Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test. Each test will be assessed in different days following a randomized order.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position. Each exercise will perform under two conditions.

On the control condition, the patients will perform both tests without any cognitive condition, while on the experimental condition they will be instructed to perform both tests while performing a mathematical subtracting task (starting at 300, by sevens).

The starting condition will be randomly assigned with a 5-minute rest prior to the next condition. Time to task failure and pain perception using a visual analog scale will be assessed.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 8150215
        • Hospital Clinico La Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20-50 years.
  • Surgery of lumbar discectomy or lumbar arthrodesis with at least 3 months of evolution.
  • Acceptance to participate in the study.

Exclusion Criteria:

  • History of previous surgery in the lower extremities.
  • Recent trauma (<6 months).
  • Use of corticosteroids.
  • Pregnancy.
  • Cauda equina syndrome.
  • Marrow-level lesions.
  • Progressive neurological involvement.
  • History of rheumatological diseases.
  • Inability to perform the test measurement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Strategy
Performing a mathematical subtracting task (starting at 300, by sevens)
Diagnostic test: Biering-Sorensen Test and Prone Plank Test
All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position.
Active Comparator: Control
The patients will perform both tests without any cognitive condition
Diagnostic test: Biering-Sorensen Test and Prone Plank Test
All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to task failure
Time Frame: through study completion, an average of 2 week
Time in seconds from 0 to failure, where higher values represent a best muscle endurance.
through study completion, an average of 2 week
Pain evaluation
Time Frame: through study completion, an average of 2 week
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
through study completion, an average of 2 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Interference: Kinesiophobia
Time Frame: through study completion, an average of 2 week
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
through study completion, an average of 2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San José, Chile

Collaborators

Hospital Clínico La Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

January 7, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSanJose

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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