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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784144
• Other study ID #: HSanJose
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: January 22, 2019

Study information

• Verified date: January 2019
• Source: Hospital San José, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 22, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Disk Herniated Lumbar
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Clínico La Florida	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San José, Chile	Hospital Clínico La Florida

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to task failure	Time in seconds from 0 to failure, where higher values represent a best muscle endurance.	through study completion, an average of 2 week
Primary	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.	through study completion, an average of 2 week
Secondary	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).	through study completion, an average of 2 week