Low Back PainNCT01085604
Recurrent Low Back Pain:Linking Mechanisms to Outcomes
An observational study of Low Back Pain, run by Drexel University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization. Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core Stabilization
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Jun 2015
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic physical therapy clinic community
Who may be able to join
- No history of low back is defined as:
- no pain limiting performance of daily activities for greater than 3 days,
- no pain for which they sought medical or allied health intervention.
- Inclusion Criteria for individuals with a history of low back pain:
- duration of the current episode of low back pain less than 3 months,
- average pain intensity over past 2 weeks at least 3 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
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- no medical intervention for low back pain in last 6 months,
- Oswestry disability score greater than 20%
- a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings.
Who cannot join
- permanent structural spinal deformity (e.g., scoliosis)
- history of spinal fracture or diagnosis of osteoporosis
- diagnosis of inflammatory joint disease
- signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
- previous spinal surgery
- frank neurological loss, i.e., weakness and sensory loss
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- history of neurologic disease that required hospitalization,
- active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
- leg length discrepancy of greater than 2.5 cm.
- pregnancy
- vestibular dysfunction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Drexel University
Philadelphia, Pennsylvania, 19102
Optimum Physical Therapy Associates
West Chester, Pennsylvania, 19380
About this study
The purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization.
Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies.
Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be tested using a known group method demonstrating:
- no significant change in motor control measures within the untreated, healthy control group.
- significant changes within the low back subjects who demonstrate clinically meaningful improvements.
Read the detailed description
A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. The aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control.
- Conditions
- Low Back Pain
- Being tested
- Core Stabilization
- Keywords
- low back pain, clinical instability, neuromuscular control, core stabilization, physical therapy
- 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.
Core StabilizationOther
The 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.
Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.
Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced.
Stage 3: emphasis on maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning.
| Study group | Role | What they receive |
|---|---|---|
| Low back pain | Individuals with current low back pain attributed to poor trunk neuromuscular control (clinical instability). Receives: Other: Core Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Neuromuscular Control
Using surface EMG, trunk kinematics and force plate parameters. Trunk motor control is characterized and compared between groups and pre/post intervention in the low back pain group.
Measured: Baseline, 8 weeks
Secondary outcomes (1)
Oswestry Disability Index
measure of functional limitations
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2015
- Study completionJun 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sheri Silfies, Drexel University
- Investigators
- Sheri P. Silfies, PT, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085604
- Sponsor's protocol ID
- K01HD053632T
- Other IDs
- K01HD053632
- Status last verified
- Jul 2018
- First submitted
- 10 Mar 2010
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sung W, Abraham M, Plastaras C, Silfies SP. Trunk motor control deficits in acute and subacute low back pain are not associated with pain or fear of movement. Spine J. 2015 Aug 1;15(8):1772-82. doi: 10.1016/j.spinee.2015.04.010. Epub 2015 Apr 8.
PubMed 25862508Mehta R, Cannella M, Henry SM, Smith S, Giszter S, Silfies SP. Trunk Postural Muscle Timing Is Not Compromised In Low Back Pain Patients Clinically Diagnosed With Movement Coordination Impairments. Motor Control. 2017 Apr;21(2):133-157. doi: 10.1123/mc.2015-0049. Epub 2016 Aug 19.
PubMed 26623551
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Low Back Pain:Linking Mechanisms to Outcomes
- ClinicalTrials.gov ID
- NCT01085604
- Acronym / sponsor ID
- K01HD053632T
- Conditions
- Low Back Pain
- Keywords
- low back pain, clinical instability, neuromuscular control, core stabilization, physical therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Mar 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 purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization.
Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies.
Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be tested using a known group method demonstrating:
- no significant change in motor control measures within the untreated, healthy control group.
- significant changes within the low back subjects who demonstrate clinically meaningful improvements.
Detailed description
A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. The aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low back pain | – | Other: Core StabilizationIndividuals with current low back pain attributed to poor trunk neuromuscular control (clinical instability). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic physical therapy clinic community
Key inclusion criteria (9 listed)
- no pain limiting performance of daily activities for greater than 3 days,
- no pain for which they sought medical or allied health intervention.
- duration of the current episode of low back pain less than 3 months,
- average pain intensity over past 2 weeks at least 3 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
- no medical intervention for low back pain in last 6 months,
Key exclusion criteria (11 listed)
- permanent structural spinal deformity (e.g., scoliosis)
- history of spinal fracture or diagnosis of osteoporosis
- diagnosis of inflammatory joint disease
- signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
- previous spinal surgery
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 |
|---|---|---|
| Core StabilizationThe 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm. Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation. Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced. Stage 3: emphasis on maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning. | Other | Low back pain |
Primary outcome
Trunk Neuromuscular Control
Time frame: Baseline, 8 weeks
Using surface EMG, trunk kinematics and force plate parameters. Trunk motor control is characterized and compared between groups and pre/post intervention in the low back pain group.
1 secondary outcome
Oswestry Disability Index
Time frame: Baseline, 8 weeks
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 2 Aug 2018.
- Results publication: PubMed 25862508Sung W, Abraham M, Plastaras C, Silfies SP. Trunk motor control deficits in acute and subacute low back pain are not associated with pain or fear of movement. Spine J. 2015 Aug 1;15(8):1772-82. doi: 10.1016/j.spinee.2015.04.010. Epub 2015 Apr 8.
- Results publication: PubMed 26623551Mehta R, Cannella M, Henry SM, Smith S, Giszter S, Silfies SP. Trunk Postural Muscle Timing Is Not Compromised In Low Back Pain Patients Clinically Diagnosed With Movement Coordination Impairments. Motor Control. 2017 Apr;21(2):133-157. doi: 10.1123/mc.2015-0049. Epub 2016 Aug 19.
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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.
Sheri P. Silfies, PT, PhD principal investigator
Drexel University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Drexel University at 2 sites in United States.
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 9 inclusion and 11 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 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Trunk Neuromuscular Control (time frame: Baseline, 8 weeks). 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 NCT01085604, 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 2 Aug 2018.