NCT03784144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

December 19, 2018

Last Update Submit

January 22, 2019

Conditions

Keywords

Muscle enduranceBiering-Sorensen TestProne Plank Test.Dual tasktime to failure

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Pain Interference: Kinesiophobia

    through study completion, an average of 2 week

Study Arms (2)

Cognitive Strategy

EXPERIMENTAL

Performing a mathematical subtracting task (starting at 300, by sevens)

Diagnostic Test: Biering-Sorensen Test and Prone Plank Test

Control

ACTIVE COMPARATOR

The patients will perform both tests without any cognitive condition

Diagnostic Test: Biering-Sorensen Test and Prone Plank Test

Interventions

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.

Cognitive StrategyControl

Eligibility Criteria

Age20 Years - 50 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico La Florida

Santiago, 8150215, Chile

Location

Related Publications (2)

  • 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.

    PMID: 20926355BACKGROUND
  • 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Each test will be assessed in different days following a randomized order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

December 3, 2018

Primary Completion

January 7, 2019

Study Completion

January 22, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.

Locations