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

• ClinicalTrials.gov Identifier: NCT03784144
• Recruitment Status: Completed
• First Posted: December 21, 2018
• Last Update Posted: January 23, 2019
• Sponsor: Hospital San José, Chile
• Collaborator: Hospital Clínico La Florida
• Information provided by (Responsible Party): Carlos Cruz Montecinos, Hospital San José, Chile

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain; Disk Herniated Lumbar	Diagnostic Test: Biering-Sorensen Test and Prone Plank Test	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each test will be assessed in different days following a randomized order.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
• Actual Study Start Date: December 3, 2018
• Actual Primary Completion Date: January 7, 2019
• Actual Study Completion Date: January 22, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Chile

Hospital Clínico La Florida

Santiago, Chile, 8150215

Sponsors and Collaborators

Hospital San José, Chile

Hospital Clínico La Florida

More Information

Publications:

Gómez-Pérez L, López-Martínez AE, Ruiz-Párraga 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cruz-Montecinos C, Núñez-Cortés R, Guzmán-González B, Andersen LL, García-Massó 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.

• Responsible Party: Carlos Cruz Montecinos, Principal Investigator, Hospital San José, Chile
• ClinicalTrials.gov Identifier: NCT03784144
• Other Study ID Numbers: HSanJose
• First Posted: December 21, 2018
• Last Update Posted: January 23, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.

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

Keywords provided by Carlos Cruz Montecinos, Hospital San José, Chile:

Muscle endurance; Biering-Sorensen Test; Prone Plank Test.; Dual task; time to failure

Additional relevant MeSH terms:

Low Back Pain; Back Pain; Pain; Neurologic Manifestations