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

Primary Purpose

Low Back Pain, Disk Herniated Lumbar

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Biering-Sorensen Test and Prone Plank Test
Sponsored by
Hospital San José, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Back Pain focused on measuring Muscle endurance, Biering-Sorensen Test, Prone Plank Test., Dual task, time to failure

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínico La Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Strategy

Control

Arm Description

Performing a mathematical subtracting task (starting at 300, by sevens)

The patients will perform both tests without any cognitive condition

Outcomes

Primary Outcome Measures

Time to task failure
Time in seconds from 0 to failure, where higher values represent a best muscle endurance.
Pain evaluation
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.

Secondary Outcome Measures

Pain Interference: Kinesiophobia
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).

Full Information

First Posted
December 19, 2018
Last Updated
January 22, 2019
Sponsor
Hospital San José, Chile
Collaborators
Hospital Clínico La Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03784144
Brief Title
Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
Official Title
Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San José, Chile
Collaborators
Hospital Clínico La Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Disk Herniated Lumbar
Keywords
Muscle endurance, Biering-Sorensen Test, Prone Plank Test., Dual task, time to failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each test will be assessed in different days following a randomized order.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Strategy
Arm Type
Experimental
Arm Description
Performing a mathematical subtracting task (starting at 300, by sevens)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The patients will perform both tests without any cognitive condition
Intervention Type
Diagnostic Test
Intervention Name(s)
Biering-Sorensen Test and Prone Plank Test
Intervention 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.
Primary Outcome Measure Information:
Title
Time to task failure
Description
Time in seconds from 0 to failure, where higher values represent a best muscle endurance.
Time Frame
through study completion, an average of 2 week
Title
Pain evaluation
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
through study completion, an average of 2 week
Secondary Outcome Measure Information:
Title
Pain Interference: Kinesiophobia
Description
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).
Time Frame
through study completion, an average of 2 week

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Clínico La Florida
City
Santiago
ZIP/Postal Code
8150215
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.
Citations:
PubMed Identifier
20926355
Citation
Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.
Results Reference
background
PubMed Identifier
32888906
Citation
Cruz-Montecinos C, Nunez-Cortes R, Guzman-Gonzalez B, Andersen LL, Garcia-Masso X, Calatayud J. The Relevance of Dual Tasking for Improving Trunk Muscle Endurance After Back Surgery. Arch Phys Med Rehabil. 2021 Mar;102(3):463-469. doi: 10.1016/j.apmr.2020.07.015. Epub 2020 Sep 2.
Results Reference
derived

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

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