Low Back Pain, MechanicalLBP-RCTNCT01567566
An Efficacy Study of Exercise Rehabilitation on Pain and Disability for Patients With Non-specific Low Back Pain
A study testing exercise rehabilitation program in people with Low Back Pain, Mechanical, run by Running Injury Clinic at 1 site in Canada.
Trial summary
The primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of NSLBP patients and aims to investigate the additive effect of hip stabilization exercises. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- exercise rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Aug 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Unilateral or bilateral NSLBP symptoms for a minimum of 6 weeks
- Current symptoms rated at least a 5/10 on a scaled from 0-10
Who cannot join
- Symptoms 'red flags' for underlying pathological conditions such as bowel and/or bladder problems, radicular symptoms, night pain
- Scoliosis
- Neurological impairment, discogenic pathology, vestibular disorder
- Pregnancy or within 1 year of giving birth
- Previous or ongoing complications from lower extremity injury or surgery in the past year
- Previous surgery to the lumbar spine or hip
- Use of any radiological interventions or injections such as prolotherapy, corticosteroid, or nerve block in the past 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Running Injury Clinic
Calgary, Alberta, T2N 1N4
Jill Baxter, BSc, 403 220 7411, jbaxter@ucalgary.ca
Karen D Kendall, PhD Cand.
About this study
Official title: The Effect of Hip Stabilizer Muscle Strengthening on Pain and Disability for Patients With Non-specific Low Back Pain: an Outcome-based Randomized Controlled Trial
The primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of NSLBP patients and aims to investigate the additive effect of hip stabilization exercises. The investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2) will be more effective in reducing pain and disability in NSLBP patients compared to the local (segmental) stabilizer program (T1).
Read the detailed description
The secondary objective of this study is to measure the changes in lumbopelvic and hip mechanics for both treatment groups following completion of the exercise programs. We hypothesize that there will be differences observed between groups following the 6wk rehabilitation programs, and that only the group completing the combined local (segmental) stabilizer and hip stabilizer strengthening program (T2) will demonstrate significant differences in mechanics compared to baseline testing.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- exercise rehabilitation program
- Keywords
- home based daily exercise program, local lumbopelvic stabilizer muscles, hip stabilizer muscles, real time ultrasound imaging
- 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.
exercise rehabilitation programOther
Also called Core stabilization exercises, Hip stabilization exercises
6 week home based exercise rehabilitation program with 6 weekly supervised sessions using real time ultrasound as biofeedback to augment training in both treatment arms
| Study group | Role | What they receive |
|---|---|---|
| Local lumbopelvic stabilizers | Active comparator | Not described Receives: Other: exercise rehabilitation program |
| Local lumbopelvic plus hip stabilizers | Experimental | Not described Receives: Other: exercise rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by a 10cm visual analogue scale
Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention
Measured: 6 weeks
Secondary outcomes (2)
Change in biomechanical variables using an eight camera motion capture system
Measures will be taken at baseline and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention
Measured: 6 weeks
Change in disability score as measured by the Oswestry Disability Questionnaire
Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Running Injury Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- WCB Alberta, Alberta Health services
- Responsible party
- Principal investigator, Karen D. Kendall, Running Injury Clinic
- Investigators
- Karen D Kendall, MKin, Principal investigator, Running Injury Clinic, Faculty of Kinesiology, University of CalgaryReed Ferber, PhD, Study director, Running Injury Clinic, Faculty of Kinesiology, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567566
- Sponsor's protocol ID
- RIC-WCB-001
- Acronym
- LBP-RCT
- Status last verified
- Mar 2012
- First submitted
- 27 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hip Stabilizer Muscle Strengthening on Pain and Disability for Patients With Non-specific Low Back Pain: an Outcome-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01567566
- Acronym / sponsor ID
- LBP-RCT / RIC-WCB-001
- Conditions
- Low Back Pain, Mechanical
- Keywords
- home based daily exercise program, local lumbopelvic stabilizer muscles, hip stabilizer muscles, real time ultrasound imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Running Injury ClinicUniversity, hospital or other
- Collaborators
- WCB Alberta, Alberta Health services
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 30 Mar 2012 (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 primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of NSLBP patients and aims to investigate the additive effect of hip stabilization exercises. The investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (T2) will be more effective in reducing pain and disability in NSLBP patients compared to the local (segmental) stabilizer program (T1).
Detailed description
The secondary objective of this study is to measure the changes in lumbopelvic and hip mechanics for both treatment groups following completion of the exercise programs. We hypothesize that there will be differences observed between groups following the 6wk rehabilitation programs, and that only the group completing the combined local (segmental) stabilizer and hip stabilizer strengthening program (T2) will demonstrate significant differences in mechanics compared to baseline testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local lumbopelvic stabilizers | Active comparator | Other: exercise rehabilitation program |
| Local lumbopelvic plus hip stabilizers | Experimental | Other: exercise rehabilitation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- Unilateral or bilateral NSLBP symptoms for a minimum of 6 weeks
- Current symptoms rated at least a 5/10 on a scaled from 0-10
Key exclusion criteria (7 listed)
- Symptoms 'red flags' for underlying pathological conditions such as bowel and/or bladder problems, radicular symptoms, night pain
- Scoliosis
- Neurological impairment, discogenic pathology, vestibular disorder
- Pregnancy or within 1 year of giving birth
- Previous or ongoing complications from lower extremity injury or surgery in the past year
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 |
|---|---|---|
| exercise rehabilitation programAlso: Core stabilization exercises, Hip stabilization exercises6 week home based exercise rehabilitation program with 6 weekly supervised sessions using real time ultrasound as biofeedback to augment training in both treatment arms | Other | Local lumbopelvic plus hip stabilizers, Local lumbopelvic stabilizers |
Primary outcome
Change in pain intensity measured by a 10cm visual analogue scale
Time frame: 6 weeks
Measures will be taken at baseline, at 3wk follow up, and at 6wk follow up to ivestigate the changes at mid point and following the exercise intervention
2 secondary outcomes
Change in biomechanical variables using an eight camera motion capture system
Time frame: 6 weeks
Change in disability score as measured by the Oswestry Disability Questionnaire
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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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.
Karen D Kendall, MKin principal investigator
Running Injury Clinic, Faculty of Kinesiology, University of Calgary
Reed Ferber, PhD study director
Running Injury Clinic, Faculty of Kinesiology, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise rehabilitation program in people with Low Back Pain, Mechanical, run by Running Injury Clinic at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 30 Mar 2012. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Baxter, BSc (403 220 7411, jbaxter@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by a 10cm visual analogue scale (time frame: 6 weeks). 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 30 Mar 2012.