Clinical trial NCT01362049: Mechanisms of Specific Trunk Exercises in Low Back Pain
Official title: Mechanisms of Specific Trunk Exercises in Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Stabilization exercise
Physical therapy
Rehabilitation
Movement System Impairment exercise
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-05-27
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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:

1. eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria ('Eligible' Subject Group); and
2. 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:

1. stabilization - a protocol focused on improving the motor control of trunk muscles to stabilize the spine; or
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Change From Baseline in Oswestry Disability Scale (0-100%)
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in Oswestry Disability Scale (0-100%)
timeFrame: Baseline and 12 Months
measure: Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change From Baseline in SF-36 Health Survey (0 - 100 Points)
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in SF-36 Health Survey (0-100 Points)
timeFrame: Baseline and 12 months
measure: Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
timeFrame: Baseline and 7 weeks
measure: Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Human Motion Analysis Lab
state: Vermont
Study officials:
affiliation: University of Vermont
name: Sharon M Henry, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.