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OpenTrials
Completed

NCT Number: NCT03784144

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

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.

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Key information

Conditions

Low Back Pain Back Pain Disk Herniated Lumbar Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico La Florida

Santiago, 8150215, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biering-Sorensen Test and Prone Plank Test

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Hospital San José, Chile

Other

Collaborators

  • Hospital Clínico La Florida

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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