Low Back PainNCT02633917
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
A study testing Standard exercises in people with Low Back Pain, run by Universidad Complutense de Madrid.
Trial summary
The purpose of the present study was to evaluate and compare the effects of motor control exercises and standard exercises in the pain, incapacity and medicine intake of subjects with unspecific low-back pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Standard exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Mar 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects should be independent to walk
- subjects should have unspecific low back pain during at least the last two months
- subjects should have had at least two recidives of low back pain within the last year
Who cannot join
- subjects with concomitant pathologies that impede the performance of exercises
- pregnants
- subjects with oncologic pathologies
- subjects with cognitive alterations that impede the understanding of the tests
About this study
Official title: Motor Control Exercises vs Standard Exercises in Patients With Unspecific Low Back Pain
The purpose of the present study was to evaluate and compare the effects of motor control exercises and standard exercises in the pain, incapacity and medicine intake of subjects with unspecific low-back pain.
Read the detailed description
Eighty-four subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated into control group (who received one hour of standard physiotherapy exercises every days during ten days) or intervention group (who received one hour of control motor exercises every days during ten days). One month after finishing these ten days, patients should perform a home-based exercises program during two months (control group performed home-based standard physiotherapy exercises; intervention group performed home-based motor control exercises). Pain (visual analogic scale), incapacity index (Roland Morris questionnaire) and medicine intake (diary) were evaluated before the intervention, one month and three months after ending the first ten days of intervention.
- Conditions
- Low Back Pain
- Being tested
- Motor control exercises, Standard exercises
- Keywords
- Low back pain, Motor control, Joint mobilization
- 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.
Motor control exercisesBehavioural
exercises to strength the lumbar musculature and control the posture
Standard exercisesBehavioural
general exercises
| Study group | Role | What they receive |
|---|---|---|
| Motor control exercises | Experimental | One group should perform motor control exercises Receives: Behavioral: Motor control exercises |
| Standard exercises | Active comparator | the other group should perform standard physiotherapy exercises Receives: Behavioral: Standard exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale.
Visual analogic scale
Measured: The day before beginning the intervention, one month and three months after the first ten days of intervention
Secondary outcomes (2)
Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.
Roland Morris questionnaire
Measured: The day before beginning the intervention, one month and three months after the first ten days of intervention
Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.
diary
Measured: The day before beginning the intervention, one month and three months after the first ten days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Plaza Manzano, Universidad Complutense de Madrid
- Investigators
- Gustavo Plaza-Manzano, Ph.D, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633917
- Sponsor's protocol ID
- CI 10/374
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control Exercises vs Standard Exercises in Patients With Unspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT02633917
- Acronym / sponsor ID
- CI 10/374
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Motor control, Joint mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Dec 2015 (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 purpose of the present study was to evaluate and compare the effects of motor control exercises and standard exercises in the pain, incapacity and medicine intake of subjects with unspecific low-back pain.
Detailed description
Eighty-four subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated into control group (who received one hour of standard physiotherapy exercises every days during ten days) or intervention group (who received one hour of control motor exercises every days during ten days). One month after finishing these ten days, patients should perform a home-based exercises program during two months (control group performed home-based standard physiotherapy exercises; intervention group performed home-based motor control exercises). Pain (visual analogic scale), incapacity index (Roland Morris questionnaire) and medicine intake (diary) were evaluated before the intervention, one month and three months after ending the first ten days of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor control exercises | Experimental | Behavioral: Motor control exercisesOne group should perform motor control exercises |
| Standard exercises | Active comparator | Behavioral: Standard exercisesthe other group should perform standard physiotherapy exercises |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects should be independent to walk
- subjects should have unspecific low back pain during at least the last two months
- subjects should have had at least two recidives of low back pain within the last year
Key exclusion criteria (4 listed)
- subjects with concomitant pathologies that impede the performance of exercises
- pregnants
- subjects with oncologic pathologies
- subjects with cognitive alterations that impede the understanding of the tests
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 |
|---|---|---|
| Motor control exercisesexercises to strength the lumbar musculature and control the posture | Behavioural | Motor control exercises |
| Standard exercisesgeneral exercises | Behavioural | Standard exercises |
Primary outcome
Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale.
Time frame: The day before beginning the intervention, one month and three months after the first ten days of intervention
Visual analogic scale
2 secondary outcomes
Change in incapacity index from baseline at one month and three months after the intervention, measured with the Roland Morris questionnaire.
Time frame: The day before beginning the intervention, one month and three months after the first ten days of intervention
Change in medication intake from baseline at one month and three months after the intervention, measured with a diary that subjects should complete.
Time frame: The day before beginning the intervention, one month and three months after the first ten days of intervention
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 17 Dec 2015.
Related trials for Low Back Pain
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode
Low Back Pain, Functional Motor Disorder
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.
Gustavo Plaza-Manzano, Ph.D study director
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Standard exercises in people with Low Back Pain, run by Universidad Complutense de Madrid.
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 4 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 17 Dec 2015. 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.
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?
Change in pain level from baseline at one month and three months after the intervention, measured with a visual analogic scale. (time frame: The day before beginning the intervention, one month and three months after the first ten days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2015.