Low Back PainPhase 2NCT01061632
High(Deadlift) Versus Low Intensity Motor Control Exercises on Low Back Pain
A Phase 2 study of Low Back Pain, run by Luleå Tekniska Universitet.
Trial summary
The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Low Back Pain
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 2
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- low back pain over 3 month
- the pain must originate locally from the lowe back and be nociceptive
Who cannot join
- -
About this study
Official title: Effects of High(Deadlift) Versus Low Intensity Motor Control Exercises on Patients With Peripherally Mediated Low Back Pain
The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain
- Conditions
- Low Back Pain
- Being tested
- High intensity motor control exercise (deadlift), Low intensity motor control exercise
- Keywords
- deadlift, motor control, exercises, pain, function, functional capacity
- Medical subject headings
- Low Back Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity motor control exercise (deadlift)Procedure or surgery
12 treatment sessions over a 8 week period is planned for the high intensity motor control exercise.
Low intensity motor control exerciseProcedure or surgery
12 sessions of low intensity motor control exercises over 8 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Selfrated function, symptoms and pain-rating
Measured: 8 weeks, 6 month, 12 month
Secondary outcomes (1)
Functional capacity
Measured: 8 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionJan 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University, Norrlandskliniken, County Council of Norrbotten, Sweden
- Responsible party
- Sponsor
- Investigators
- Kerstin Öhrling, As professor, Study director, Luleå Tekniska Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061632
- Sponsor's protocol ID
- LTU_marklyft
- Status last verified
- Mar 2013
- First submitted
- 20 Jan 2010
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.
PubMed 25641309Berglund L, Aasa B, Hellqvist J, Michaelson P, Aasa U. Which Patients With Low Back Pain Benefit From Deadlift Training? J Strength Cond Res. 2015 Jul;29(7):1803-11. doi: 10.1519/JSC.0000000000000837.
PubMed 25559899
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High(Deadlift) Versus Low Intensity Motor Control Exercises on Patients With Peripherally Mediated Low Back Pain
- ClinicalTrials.gov ID
- NCT01061632
- Acronym / sponsor ID
- LTU_marklyft
- Conditions
- Low Back Pain
- Keywords
- deadlift, motor control, exercises, pain, function, functional capacity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Collaborators
- Umeå University, Norrlandskliniken, County Council of Norrbotten, Sweden
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Feb 2010 (estimated)
- 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.
The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- low back pain over 3 month
- the pain must originate locally from the lowe back and be nociceptive
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| High intensity motor control exercise (deadlift)12 treatment sessions over a 8 week period is planned for the high intensity motor control exercise. | Procedure or surgery | – |
| Low intensity motor control exercise12 sessions of low intensity motor control exercises over 8 weeks | Procedure or surgery | – |
Primary outcome
Selfrated function, symptoms and pain-rating
Time frame: 8 weeks, 6 month, 12 month
1 secondary outcome
Functional capacity
Time frame: 8 weeks, 6 months
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 8 Mar 2013.
- Derived from this study: PubMed 25641309Aasa B, Berglund L, Michaelson P, Aasa U. Individualized low-load motor control exercises and education versus a high-load lifting exercise and education to improve activity, pain intensity, and physical performance in patients with low back pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Feb;45(2):77-85, B1-4. doi: 10.2519/jospt.2015.5021.
- Derived from this study: PubMed 25559899Berglund L, Aasa B, Hellqvist J, Michaelson P, Aasa U. Which Patients With Low Back Pain Benefit From Deadlift Training? J Strength Cond Res. 2015 Jul;29(7):1803-11. doi: 10.1519/JSC.0000000000000837.
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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.
Kerstin Öhrling, As professor study director
Luleå Tekniska Universitet
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Low Back Pain, run by Luleå Tekniska Universitet.
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 2 inclusion and 1 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Selfrated function, symptoms and pain-rating (time frame: 8 weeks, 6 month, 12 month). 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 NCT01061632, 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 8 Mar 2013.