- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03784144
Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Santiago, Chile, 8150215
- Hospital Clinico La Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Strategy
Performing a mathematical subtracting task (starting at 300, by sevens)
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of 2 week
|
|
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.
|
through study completion, an average of 2 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
through study completion, an average of 2 week
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSanJose
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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