Mechanisms of Specific Trunk Exercises in Low Back Pain

NCT01362049 | Completed Results DMC

• 2 other identifiers: CHRMS 10-0455R01HD040909-07
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Stabilization exercise; Physical therapy; Rehabilitation; Movement System Impairment exercise

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Change From Baseline in SF-36 Health Survey (0 - 100 Points)

  Baseline and 7 weeks

• Change From Baseline in SF-36 Health Survey (0-100 Points)

  Baseline and 12 months

• Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)

  Baseline and 7 weeks

• Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)

  Baseline and 12 months

Study Arms (4)

'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.

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

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.

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

Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise

Interventions

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.

Also known as: Trunk stabilization exercises, Segmental stabilization exercises

'Eligible' Subject Group - STAB; 'Ineligible' Subject Group - STAB

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.

Also known as: Specific exercise, Sarhmann exercise approach, MSI exercises

'Eligible' Subject Group - MSI; 'Ineligible' Subject Group -MSI

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Vermont: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Human Motion Analysis Lab

Burlington, Vermont, 05401, United States

Location

Related Publications (12)

• 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.

  PMID: 27771534 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.

  PMID: 26762185 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.

  PMID: 26623551 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.

  PMID: 26324322 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.

  PMID: 22796388 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.

  PMID: 23313039 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.

  PMID: 23507347 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.

  PMID: 23228626 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.

  PMID: 22677525 BACKGROUND

• 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.

  PMID: 25452017 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.

  PMID: 24662210 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.

  PMID: 24065623 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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).

Results Point of Contact

• Title: Dr. Sharon M. Henry
• Organization: University of Vermont Medical Center, Burlington, VT

Sharon.Henry@uvm.edu

(802) 847-7633

Study Officials

• Sharon M Henry, PT, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 27, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2013
• Last Updated: June 5, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)