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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03784144
Other study ID # HSanJose
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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