Low Back PainNCT03784144
Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
A study testing Biering-Sorensen Test and Prone Plank Test in people with Low Back Pain and Disk Herniated Lumbar, run by Hospital San José, Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain, Disk Herniated Lumbar
- What is being tested?
- Biering-Sorensen Test and Prone Plank Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChile
- Study dates
- 3 Dec 2018to 22 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- History of previous surgery in the lower extremities.
- Recent trauma (<6 months).
- Use of corticosteroids.
- Pregnancy.
- Cauda equina syndrome.
- Marrow-level lesions.
Show all 9Show fewer
- Progressive neurological involvement.
- History of rheumatological diseases.
- Inability to perform the test measurement.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain, Disk Herniated Lumbar
- Being tested
- Biering-Sorensen Test and Prone Plank Test
- Keywords
- Muscle endurance, Biering-Sorensen Test, Prone Plank Test., Dual task, time to failure
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biering-Sorensen Test and Prone Plank TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Strategy | Experimental | Performing a mathematical subtracting task (starting at 300, by sevens) Receives: Diagnostic Test: Biering-Sorensen Test and Prone Plank Test |
| Control | Active comparator | The patients will perform both tests without any cognitive condition Receives: Diagnostic Test: Biering-Sorensen Test and Prone Plank Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to task failure
Time in seconds from 0 to failure, where higher values represent a best muscle endurance.
Measured: 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.
Measured: through study completion, an average of 2 week
Secondary outcomes (1)
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).
Measured: through study completion, an average of 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start3 Dec 2018
- Primary completion7 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each test will be assessed in different days following a randomized order.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San José, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico La Florida
- Responsible party
- Principal investigator, Carlos Cruz Montecinos, Hospital San José, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784144
- Sponsor's protocol ID
- HSanJose
- Status last verified
- Jan 2019
- First submitted
- 19 Dec 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.
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.
PubMed 20926355Cruz-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.
PubMed 32888906
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
- ClinicalTrials.gov ID
- NCT03784144
- Acronym / sponsor ID
- HSanJose
- Conditions
- Low Back Pain, Disk Herniated Lumbar
- Keywords
- Muscle endurance, Biering-Sorensen Test, Prone Plank Test., Dual task, time to failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital San José, ChileUniversity, hospital or other
- Collaborators
- Hospital Clínico La Florida
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each test will be assessed in different days following a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Strategy | Experimental | Diagnostic Test: Biering-Sorensen Test and Prone Plank TestPerforming a mathematical subtracting task (starting at 300, by sevens) |
| Control | Active comparator | Diagnostic Test: Biering-Sorensen Test and Prone Plank TestThe patients will perform both tests without any cognitive condition |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- History of previous surgery in the lower extremities.
- Recent trauma (<6 months).
- Use of corticosteroids.
- Pregnancy.
- Cauda equina syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biering-Sorensen Test and Prone Plank TestAll patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position. | Diagnostic test | Cognitive Strategy, Control |
Primary outcome
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.
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.
1 secondary outcome
Pain Interference: Kinesiophobia
Time frame: through study completion, an average of 2 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 20926355Gomez-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.
- Derived from this study: PubMed 32888906Cruz-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.
- Individual participant dataSharing planned: No. Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biering-Sorensen Test and Prone Plank Test in people with Low Back Pain and Disk Herniated Lumbar, run by Hospital San José, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to task failure (time frame: through study completion, an average of 2 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.