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Mechanisms of Specific Trunk Exercises in Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy rehabilitation: Stabilization exercises.
Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Stabilization exercise, Physical therapy, Rehabilitation, Movement System Impairment exercise

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Human Motion Analysis Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

'Eligible' Subject Group - STAB

'Ineligible' Subject Group - STAB

'Eligible' Subject Group - MSI

'Ineligible' Subject Group -MSI

Arm Description

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: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level.

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

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: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level.

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

Outcomes

Primary Outcome Measures

Change From Baseline in Oswestry Disability Scale (0-100%)
Disability; Sacle 0-100% Lower score is considered better/improved
Change From Baseline in Oswestry Disability Scale (0-100%)
Disability; Sacle 0-100% Lower score is considered better/improved
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
May 24, 2011
Last Updated
May 1, 2017
Sponsor
University of Vermont
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01362049
Brief Title
Mechanisms of Specific Trunk Exercises in Low Back Pain
Official Title
Mechanisms of Specific Trunk Exercises in Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Stabilization exercise, Physical therapy, Rehabilitation, Movement System Impairment exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
'Eligible' Subject Group - STAB
Arm Type
Active Comparator
Arm Description
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: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level.
Arm Title
'Ineligible' Subject Group - STAB
Arm Type
Active Comparator
Arm Description
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
Arm Title
'Eligible' Subject Group - MSI
Arm Type
Active Comparator
Arm Description
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: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level.
Arm Title
'Ineligible' Subject Group -MSI
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Physical Therapy rehabilitation: Stabilization exercises.
Other Intervention Name(s)
Trunk stabilization exercises, Segmental stabilization exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
Other Intervention Name(s)
Specific exercise, Sarhmann exercise approach, MSI exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Oswestry Disability Scale (0-100%)
Description
Disability; Sacle 0-100% Lower score is considered better/improved
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in Oswestry Disability Scale (0-100%)
Description
Disability; Sacle 0-100% Lower score is considered better/improved
Time Frame
Baseline and 12 Months
Title
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Description
Current Pain Scale 0-10 Lower score is better/improved
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Description
Current Pain Scale 0-10 Lower score is better/improved
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline in SF-36 Health Survey (0 - 100 Points)
Description
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in SF-36 Health Survey (0-100 Points)
Description
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Time Frame
Baseline and 12 months
Title
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
Description
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
Time Frame
Baseline and 7 weeks
Title
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
Description
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
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon M Henry, PT, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Motion Analysis Lab
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27771534
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.
Results Reference
background
PubMed Identifier
26762185
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.
Results Reference
background
PubMed Identifier
26623551
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.
Results Reference
background
PubMed Identifier
26324322
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.
Results Reference
background
PubMed Identifier
22796388
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.
Results Reference
background
PubMed Identifier
23313039
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.
Results Reference
background
PubMed Identifier
23507347
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.
Results Reference
background
PubMed Identifier
23228626
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.
Results Reference
background
PubMed Identifier
22677525
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.
Results Reference
background
PubMed Identifier
25452017
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.
Results Reference
result
PubMed Identifier
24662210
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.
Results Reference
result
PubMed Identifier
24065623
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.
Results Reference
result

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Mechanisms of Specific Trunk Exercises in Low Back Pain

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