Low Back PainNCT01362049
Mechanisms of Specific Trunk Exercises in Low Back Pain
A study testing Physical Therapy rehabilitation: Stabilization exercises. and Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise in people with Low Back Pain, run by University of Vermont at 1 site in United States.
Trial summary
The research objective is to determine which physical therapy (PT) treatment is the most efficacious for patients with lower back pain (LBP), who have been subgrouped based on certain clinical features. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physical Therapy rehabilitation: Stabilization exercises. and Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a history of chronic LBP with or without recurrences for a minimum of 12 months;
- between 21 - 55 years of age;
- able to stand and walk without assistance;
- have an Oswestry Disability Score of 19% or higher AND/OR less than an 8 on one activity reported on the Patient Specific Functional Scale,
Who cannot join
- any major structural spinal deformity including scoliosis, kyphosis, or stenosis;
- spinal fracture or dislocation;
- osteoporosis;
- ankylosing spondylitis;
- rheumatoid arthritis;
- disc herniation with corroborating clinical signs and symptoms;
Show all 19Show fewer
- serious spinal complications such as tumor or infection;
- previous spinal surgery;
- frank neurological loss, i.e., weakness and sensory loss;
- pain or paresthesia below the knee;
- etiology of LBP other than the lumbar spine, e.g., hip joint;
- history of neurological disease which required hospitalization;
- active treatment for cancer;
- history of unresolved cancer;
- pregnancy or less than 6 months post-partum or less than 6 months post weaning;
- magnified symptom-behavior;
- worker's compensation or disability case;
- in litigation for the LBP problem;
- have a BMI ≥ 30.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Motion Analysis Lab
Burlington, Vermont, 05401
About this study
The research objective is to determine which physical therapy (PT) treatment is the most efficacious for patients with lower back pain (LBP), who have been subgrouped based on certain clinical features. There is only limited evidence that supports any one PT treatment for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given the heterogeneous clinical features of patients with LBP. Thus, classification of patients with LBP into subgroups with shared clinical features has been identified as a research priority by several groups in order to prescribe the most efficacious PT treatment for each homogeneous subgroup. The investigators hypothesize that particular PT treatments are most efficacious when applied to patients with LBP, who present with particular clinical and neuromuscular features.
Read the detailed description
The proposed studies focus on 2 schemas to classify LBP: 1) the Treatment-Based Classification (TBC) system, from which clinical prediction rules about who is most likely to benefit from spinal stabilization exercises (among others) have been developed, and 2) the Movement System Impairment-Based Classification (MSI) system, which includes 5 classifications of LBP named for the specific direction(s) of movements and alignments associated with the person's LBP.
The primary purpose of this proposal is to conduct a prospective, randomized, controlled Phase II clinical trial in order to examine whether or not treatment matched to a patient's specific signs and symptoms (patient-matched) per the TBC is more effective than the MSI system for improving short- (6 weeks) and long-term (12 and 24 months) outcomes in people with chronic LBP. A secondary purpose is to identify prognostic factors that predict clinical outcomes in the 2 treatment groups being compared.
Subjects will be assigned to one of two study arms:
- eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria ('Eligible' Subject Group); and
- subjects who are not eligible for the TBC-based stabilization exercises ('Ineligible' Subject Group).
Within in each study arm, subjects will be randomly assigned to 1 of 2 exercise protocols for a 6-week period:
- stabilization - a protocol focused on improving the motor control of trunk muscles to stabilize the spine; or
- MSI-based - a classification-specific treatment focused on education and instruction for modifying movement strategies during functional activities, and on exercises specific to the classification category.
Laboratory measures (muscle activation, kinematics, forces) during standardized tasks will quantify neuromuscular impairments associated with LBP and clinical questionnaires will quantify changes in pain, function, and health status pre- and post-treatment. The addition of neuromuscular measures to these classification schemas could improve the sensitivity and specificity of each.
- Conditions
- Low Back Pain
- Being tested
- Physical Therapy rehabilitation: Stabilization exercises., Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
- Keywords
- Stabilization exercise, Physical therapy, Rehabilitation, Movement System Impairment exercise
- 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.
Physical Therapy rehabilitation: Stabilization exercises.Other
Also called Trunk stabilization exercises, Segmental stabilization exercises
The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exerciseOther
Also called Specific exercise, Sarhmann exercise approach, MSI exercises
The MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 'Eligible' Subject Group - STAB | Active comparator | Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise > 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Receives: Other: Physical Therapy rehabilitation: Stabilization exercises. |
| 'Ineligible' Subject Group - STAB | Active comparator | Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Receives: Other: Physical Therapy rehabilitation: Stabilization exercises. |
| 'Eligible' Subject Group - MSI | Active comparator | Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise > 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Receives: Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise |
| 'Ineligible' Subject Group -MSI | Active comparator | Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Receives: Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Oswestry Disability Scale (0-100%)
Disability; Sacle 0-100% Lower score is considered better/improved
Measured: Baseline and 7 weeks
Change From Baseline in Oswestry Disability Scale (0-100%)
Disability; Sacle 0-100% Lower score is considered better/improved
Measured: Baseline and 12 Months
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved
Measured: Baseline and 7 weeks
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved
Measured: Baseline and 12 months
Secondary outcomes (4)
Change From Baseline in SF-36 Health Survey (0 - 100 Points)
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Measured: Baseline and 7 weeks
Change From Baseline in SF-36 Health Survey (0-100 Points)
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Measured: Baseline and 12 months
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Measured: Baseline and 7 weeks
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sharon M. Henry, University of Vermont
- Investigators
- Sharon M Henry, PT, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362049
- Sponsor's protocol ID
- CHRMS 10-045
- Other IDs
- 5R01HD040909-07
- Status last verified
- May 2017
- First submitted
- 24 May 2011
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jacobs JV, Roy CL, Hitt JR, Popov RE, Henry SM. Neural mechanisms and functional correlates of altered postural responses to perturbed standing balance with chronic low back pain. Neuroscience. 2016 Dec 17;339:511-524. doi: 10.1016/j.neuroscience.2016.10.032. Epub 2016 Oct 19.
PubMed 27771534Boucher JA, Preuss R, Henry SM, Dumas JP, Lariviere C. The effects of an 8-week stabilization exercise program on lumbar movement sense in patients with low back pain. BMC Musculoskelet Disord. 2016 Jan 14;17:23. doi: 10.1186/s12891-016-0875-4.
PubMed 26762185Mehta 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 26623551Jacobs JV, Lomond KV, Hitt JR, DeSarno MJ, Bunn JY, Henry SM. Effects of low back pain and of stabilization or movement-system-impairment treatments on induced postural responses: A planned secondary analysis of a randomised controlled trial. Man Ther. 2016 Feb;21:210-9. doi: 10.1016/j.math.2015.08.006. Epub 2015 Aug 21.
PubMed 26324322Henry SM, Van Dillen LR, Trombley AR, Dee JM, Bunn JY. Reliability of novice raters in using the movement system impairment approach to classify people with low back pain. Man Ther. 2013 Feb;18(1):35-40. doi: 10.1016/j.math.2012.06.008. Epub 2012 Jul 15.
PubMed 22796388Lariviere C, Gagnon D, De Oliveira E Jr, Henry SM, Mecheri H, Dumas JP. Reliability of ultrasound measures of the transversus abdominis: effect of task and transducer position. PM R. 2013 Feb;5(2):104-13. doi: 10.1016/j.pmrj.2012.11.002. Epub 2013 Jan 10.
PubMed 23313039Lariviere C, Gagnon D, De Oliveira E Jr, Henry SM, Mecheri H, Dumas JP. Ultrasound measures of the lumbar multifidus: effect of task and transducer position on reliability. PM R. 2013 Aug;5(8):678-87. doi: 10.1016/j.pmrj.2013.03.010. Epub 2013 Mar 15.
PubMed 23507347Zielinski KA, Henry SM, Ouellette-Morton RH, DeSarno MJ. Lumbar multifidus muscle thickness does not predict patients with low back pain who improve with trunk stabilization exercises. Arch Phys Med Rehabil. 2013 Jun;94(6):1132-8. doi: 10.1016/j.apmr.2012.12.001. Epub 2012 Dec 7.
PubMed 23228626Henry SM, Fritz JM, Trombley AR, Bunn JY. Reliability of a treatment-based classification system for subgrouping people with low back pain. J Orthop Sports Phys Ther. 2012 Sep;42(9):797-805. doi: 10.2519/jospt.2012.4078. Epub 2012 Jun 7.
PubMed 22677525Lomond KV, Jacobs JV, Hitt JR, DeSarno MJ, Bunn JY, Henry SM. Effects of low back pain stabilization or movement system impairment treatments on voluntary postural adjustments: a randomized controlled trial. Spine J. 2015 Apr 1;15(4):596-606. doi: 10.1016/j.spinee.2014.10.020. Epub 2014 Oct 29.
PubMed 25452017Henry SM, Van Dillen LR, Ouellette-Morton RH, Hitt JR, Lomond KV, DeSarno MJ, Bunn JY. Outcomes are not different for patient-matched versus nonmatched treatment in subjects with chronic recurrent low back pain: a randomized clinical trial. Spine J. 2014 Dec 1;14(12):2799-810. doi: 10.1016/j.spinee.2014.03.024. Epub 2014 Mar 22.
PubMed 24662210Lomond KV, Henry SM, Jacobs JV, Hitt JR, Horak FB, Cohen RG, Schwartz D, Dumas JA, Naylor MR, Watts R, DeSarno MJ. Protocol to assess the neurophysiology associated with multi-segmental postural coordination. Physiol Meas. 2013 Oct;34(10):N97-105. doi: 10.1088/0967-3334/34/10/N97. Epub 2013 Sep 25.
PubMed 24065623
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Specific Trunk Exercises in Low Back Pain
- ClinicalTrials.gov ID
- NCT01362049
- Acronym / sponsor ID
- CHRMS 10-045
- Conditions
- Low Back Pain
- Keywords
- Stabilization exercise, Physical therapy, Rehabilitation, Movement System Impairment exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research objective is to determine which physical therapy (PT) treatment is the most efficacious for patients with lower back pain (LBP), who have been subgrouped based on certain clinical features. There is only limited evidence that supports any one PT treatment for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given the heterogeneous clinical features of patients with LBP. Thus, classification of patients with LBP into subgroups with shared clinical features has been identified as a research priority by several groups in order to prescribe the most efficacious PT treatment for each homogeneous subgroup. The investigators hypothesize that particular PT treatments are most efficacious when applied to patients with LBP, who present with particular clinical and neuromuscular features.
Detailed description
The proposed studies focus on 2 schemas to classify LBP: 1) the Treatment-Based Classification (TBC) system, from which clinical prediction rules about who is most likely to benefit from spinal stabilization exercises (among others) have been developed, and 2) the Movement System Impairment-Based Classification (MSI) system, which includes 5 classifications of LBP named for the specific direction(s) of movements and alignments associated with the person's LBP.
The primary purpose of this proposal is to conduct a prospective, randomized, controlled Phase II clinical trial in order to examine whether or not treatment matched to a patient's specific signs and symptoms (patient-matched) per the TBC is more effective than the MSI system for improving short- (6 weeks) and long-term (12 and 24 months) outcomes in people with chronic LBP. A secondary purpose is to identify prognostic factors that predict clinical outcomes in the 2 treatment groups being compared.
Subjects will be assigned to one of two study arms:
- eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria ('Eligible' Subject Group); and
- subjects who are not eligible for the TBC-based stabilization exercises ('Ineligible' Subject Group).
Within in each study arm, subjects will be randomly assigned to 1 of 2 exercise protocols for a 6-week period:
- stabilization - a protocol focused on improving the motor control of trunk muscles to stabilize the spine; or
- MSI-based - a classification-specific treatment focused on education and instruction for modifying movement strategies during functional activities, and on exercises specific to the classification category.
Laboratory measures (muscle activation, kinematics, forces) during standardized tasks will quantify neuromuscular impairments associated with LBP and clinical questionnaires will quantify changes in pain, function, and health status pre- and post-treatment. The addition of neuromuscular measures to these classification schemas could improve the sensitivity and specificity of each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 'Eligible' Subject Group - STAB | Active comparator | Other: Physical Therapy rehabilitation: Stabilization exercises.Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: 1. straight leg raise > 90 degrees 2. aberrant trunk movement with trunk forward flexion 3. positive prone instability test AND/OR 4. passive lumbar mobility testing that is judged to be hypermobile at any level. |
| 'Ineligible' Subject Group - STAB | Active comparator | Other: Physical Therapy rehabilitation: Stabilization exercises.Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria |
| 'Eligible' Subject Group - MSI | Active comparator | Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exerciseSubjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: 1. straight leg raise > 90 degrees 2. aberrant trunk movement with trunk forward flexion 3. positive prone instability test AND/OR 4. passive lumbar mobility testing that is judged to be hypermobile at any level. |
| 'Ineligible' Subject Group -MSI | Active comparator | Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exerciseSubjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- a history of chronic LBP with or without recurrences for a minimum of 12 months;
- between 21 - 55 years of age;
- able to stand and walk without assistance;
- have an Oswestry Disability Score of 19% or higher AND/OR less than an 8 on one activity reported on the Patient Specific Functional Scale,
Key exclusion criteria (19 listed)
- any major structural spinal deformity including scoliosis, kyphosis, or stenosis;
- spinal fracture or dislocation;
- osteoporosis;
- ankylosing spondylitis;
- rheumatoid arthritis;
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 |
|---|---|---|
| Physical Therapy rehabilitation: Stabilization exercises.Also: Trunk stabilization exercises, Segmental stabilization exercisesThe stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions. | Other | 'Eligible' Subject Group - STAB, 'Ineligible' Subject Group - STAB |
| Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exerciseAlso: Specific exercise, Sarhmann exercise approach, MSI exercisesThe MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms. | Other | 'Eligible' Subject Group - MSI, 'Ineligible' Subject Group -MSI |
Primary outcome
Change From Baseline in Oswestry Disability Scale (0-100%)
Time frame: Baseline and 7 weeks
Disability; Sacle 0-100% Lower score is considered better/improved
Change From Baseline in Oswestry Disability Scale (0-100%)
Time frame: Baseline and 12 Months
Disability; Sacle 0-100% Lower score is considered better/improved
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Time frame: Baseline and 7 weeks
Current Pain Scale 0-10 Lower score is better/improved
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Time frame: Baseline and 12 months
Current Pain Scale 0-10 Lower score is better/improved
4 secondary outcomes
Change From Baseline in SF-36 Health Survey (0 - 100 Points)
Time frame: Baseline and 7 weeks
Change From Baseline in SF-36 Health Survey (0-100 Points)
Time frame: Baseline and 12 months
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
Time frame: Baseline and 7 weeks
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27771534Jacobs JV, Roy CL, Hitt JR, Popov RE, Henry SM. Neural mechanisms and functional correlates of altered postural responses to perturbed standing balance with chronic low back pain. Neuroscience. 2016 Dec 17;339:511-524. doi: 10.1016/j.neuroscience.2016.10.032. Epub 2016 Oct 19.
- Background: PubMed 26762185Boucher JA, Preuss R, Henry SM, Dumas JP, Lariviere C. The effects of an 8-week stabilization exercise program on lumbar movement sense in patients with low back pain. BMC Musculoskelet Disord. 2016 Jan 14;17:23. doi: 10.1186/s12891-016-0875-4.
- Background: 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.
- Background: PubMed 26324322Jacobs JV, Lomond KV, Hitt JR, DeSarno MJ, Bunn JY, Henry SM. Effects of low back pain and of stabilization or movement-system-impairment treatments on induced postural responses: A planned secondary analysis of a randomised controlled trial. Man Ther. 2016 Feb;21:210-9. doi: 10.1016/j.math.2015.08.006. Epub 2015 Aug 21.
- Background: PubMed 22796388Henry SM, Van Dillen LR, Trombley AR, Dee JM, Bunn JY. Reliability of novice raters in using the movement system impairment approach to classify people with low back pain. Man Ther. 2013 Feb;18(1):35-40. doi: 10.1016/j.math.2012.06.008. Epub 2012 Jul 15.
- Background: PubMed 23313039Lariviere C, Gagnon D, De Oliveira E Jr, Henry SM, Mecheri H, Dumas JP. Reliability of ultrasound measures of the transversus abdominis: effect of task and transducer position. PM R. 2013 Feb;5(2):104-13. doi: 10.1016/j.pmrj.2012.11.002. Epub 2013 Jan 10.
- Background: PubMed 23507347Lariviere C, Gagnon D, De Oliveira E Jr, Henry SM, Mecheri H, Dumas JP. Ultrasound measures of the lumbar multifidus: effect of task and transducer position on reliability. PM R. 2013 Aug;5(8):678-87. doi: 10.1016/j.pmrj.2013.03.010. Epub 2013 Mar 15.
- Background: PubMed 23228626Zielinski KA, Henry SM, Ouellette-Morton RH, DeSarno MJ. Lumbar multifidus muscle thickness does not predict patients with low back pain who improve with trunk stabilization exercises. Arch Phys Med Rehabil. 2013 Jun;94(6):1132-8. doi: 10.1016/j.apmr.2012.12.001. Epub 2012 Dec 7.
- Background: PubMed 22677525Henry SM, Fritz JM, Trombley AR, Bunn JY. Reliability of a treatment-based classification system for subgrouping people with low back pain. J Orthop Sports Phys Ther. 2012 Sep;42(9):797-805. doi: 10.2519/jospt.2012.4078. Epub 2012 Jun 7.
- Results publication: PubMed 25452017Lomond KV, Jacobs JV, Hitt JR, DeSarno MJ, Bunn JY, Henry SM. Effects of low back pain stabilization or movement system impairment treatments on voluntary postural adjustments: a randomized controlled trial. Spine J. 2015 Apr 1;15(4):596-606. doi: 10.1016/j.spinee.2014.10.020. Epub 2014 Oct 29.
- Results publication: PubMed 24662210Henry SM, Van Dillen LR, Ouellette-Morton RH, Hitt JR, Lomond KV, DeSarno MJ, Bunn JY. Outcomes are not different for patient-matched versus nonmatched treatment in subjects with chronic recurrent low back pain: a randomized clinical trial. Spine J. 2014 Dec 1;14(12):2799-810. doi: 10.1016/j.spinee.2014.03.024. Epub 2014 Mar 22.
- Results publication: PubMed 24065623Lomond KV, Henry SM, Jacobs JV, Hitt JR, Horak FB, Cohen RG, Schwartz D, Dumas JA, Naylor MR, Watts R, DeSarno MJ. Protocol to assess the neurophysiology associated with multi-segmental postural coordination. Physiol Meas. 2013 Oct;34(10):N97-105. doi: 10.1088/0967-3334/34/10/N97. Epub 2013 Sep 25.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Sharon M Henry, PT, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy rehabilitation: Stabilization exercises. and Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise in people with Low Back Pain, run by University of Vermont at 1 site 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 4 inclusion and 19 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 5 Jun 2017. 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 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Oswestry Disability Scale (0-100%) (time frame: Baseline and 7 weeks). The study lists 4 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 NCT01362049, which also lists 12 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 5 Jun 2017.