Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD040909-07 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Within in each study arm, subjects will be randomly assigned to 1 of 2 exercise protocols for a 6-week period:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| '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:
|
|
| '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 |
|
| '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:
|
|
| '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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy rehabilitation: Stabilization exercises. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved | Baseline and 7 weeks |
| Change From Baseline in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved | 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 | 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 | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 7 weeks |
| Change From Baseline in SF-36 Health Survey (0-100 Points) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharon M Henry, PT, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Motion Analysis Lab | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27771534 | Background | 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. | |
| 26762185 | Background | Boucher 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 'Eligible' Subject Group - MSI Treatment | 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:
|
| FG001 | 'Eligible' Subject Group - STAB Treatment | 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:
|
| FG002 | 'Ineligible' Subject Group - MSI Treatment | 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. Received MSI- matched treatment |
| FG003 | 'Ineligible' Subject Group - STAB Treatment | 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. Received STAB treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Follow-Up at 7 Weeks |
|
| |||||||||||||||||||||
| Follow-Up at 52 Weeks (12 Months) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 'Eligible' Subject Group - MSI Treatment | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 weeks |
|
Baseline, 7 weeks, 1 year (12 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 'Eligible' Subject Group - MSI Treatment | 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:
|
Not provided
Not provided
The sample size was relatively small, providing adequate power for only comparing the matched to unmatched treatments (and not the stabilization vs. Movement System Impairment exercises).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon M. Henry | University of Vermont Medical Center, Burlington, VT | (802) 847-7633 | Sharon.Henry@uvm.edu |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
|
| Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise | Other | 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. |
|
|
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
| 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 | 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 | Baseline and 12 months |
| 26623551 | Background | Mehta 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. |
| 26324322 | Background | Jacobs 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. |
| 22796388 | Background | Henry 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. |
| 23313039 | Background | Lariviere 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. |
| 23507347 | Background | Lariviere 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. |
| 23228626 | Background | Zielinski 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. |
| 22677525 | Background | Henry 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. |
| 25452017 | Result | Lomond 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. |
| 24662210 | Result | Henry 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. |
| 24065623 | Result | Lomond 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 'Eligible' Subject Group - STAB Treatment | 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:
|
| BG002 | 'Ineligible' Subject Group - MSI Treatment | 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. Received MSI-match treatment |
| BG003 | 'Ineligible' Subject Group - STAB Treatment | 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. Received STAB treatment |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 'Ineligible' Subject Group -MSI | 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 and who received MSI exercises for treatment. |
| OG003 | 'Ineligible' Subject Group - STAB | 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 Physical Therapy rehabilitation: 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. |
|
|
| Primary | Change From Baseline in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Months |
|
|
|
| Primary | Change From Baseline in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 weeks |
|
|
|
| Primary | Change From Baseline in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
|
| Secondary | 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 | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 weeks |
|
|
|
| Secondary | 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 | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
|
| Secondary | 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 | Participants with available data are included | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 weeks |
|
|
|
| Secondary | 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 | Participants with available data are included | Posted | Median | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 'Eligible' Subject Group - STAB | 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:
| 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | 'Ineligible' Subject Group - MSI Treatment | 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 Received MSI-matched treatment | 0 | 32 | 0 | 32 | 0 | 32 |
| EG003 | 'Ineligible' Subject Group - STAB Treatment | 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. Received STAB treatment | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |