Mechanisms of Specific Trunk Exercises in Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Vermont.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon M. Henry, University of Vermont
ClinicalTrials.gov Identifier:
NCT01362049
First received: May 24, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Other: Physical Therapy rehabilitation: Stabilization exercises.
Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mechanisms of Specific Trunk Exercises in Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Change from baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Oswestry Disability Scale (0-100%) [ Time Frame: 6 Weeks and 12 Months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Oswestry Disability Scale (0-100%) [ Time Frame: 6 Weeks and 24 Months ] [ Designated as safety issue: No ]
  • Change from 12 months in Oswestry Disability Scale (0-100%) [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in Numeric Pain Rating Scale (0-10 points) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Numeric Pain Rating Scale (0-10 points) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in Numeric Pain Rating Scale (0-10 points) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Numeric Pain Rating Scale (0-10 points) [ Time Frame: 6 weeks and 12 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Numeric Pain Rating Scale (0-10 points) [ Time Frame: 6 weeks and 24 months ] [ Designated as safety issue: No ]
  • Change from 12 months in Numeric Pain Rating Scale (0-10 points) [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in SF-36 Health Survey (0 - 100 points) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in SP-36 Health Survey (0-100 points) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in SP-36 Health Survey (0-100 points) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in SP-36 Health Survey (0-100 points) [ Time Frame: 6 weeks and 12 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in SP-36 Health Survey (0-100 points) [ Time Frame: 6 weeks and 24 months ] [ Designated as safety issue: No ]
  • Change from 12 months in SP-36 Health Survey (0-100 points) [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in Fear Avoidance Belief Questionnaire (physical activity subscale 0-24 points; work subscale 0-42 points) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Fear Avoidance Belief Questionnaire (physical activity subscale 0-24 points; work subscale 0-42 points) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in Fear Avoidance Belief Questionnaire (physical activity subscale 0-24 points; work subscale 0-42 points) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Fear Avoidance Belief Questionnaire (physical activity subscale 0-24 points; work subscale 0-42 points) [ Time Frame: 6 weeks and 12 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Fear Avoidance Belief Questionnaire (physical activity subscale 0-24 points; work subscale 0-42 points) [ Time Frame: 6 weeks and 24 months ] [ Designated as safety issue: No ]
  • Change from 12 months in Fear Avoidance Belief Questionnaire (physical activity subscale 0-24 points; work subscale 0-42 points) [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 93
Study Start Date: March 2010
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 'Eligible' Subject Group

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.
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.
Other Names:
  • Trunk stabilization exercises
  • Segmental stabilization exercises
Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
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.
Other Names:
  • Specific exercise
  • Sarhmann exercise approach
  • MSI exercises
Active Comparator: 'Ineligible' Subject Group
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.
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.
Other Names:
  • Trunk stabilization exercises
  • Segmental stabilization exercises
Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise
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.
Other Names:
  • Specific exercise
  • Sarhmann exercise approach
  • MSI exercises

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362049

Locations
United States, Vermont
Human Motion Analysis Lab
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Sharon M Henry, PT, PhD University of Vermont
  More Information

No publications provided

Responsible Party: Sharon M. Henry, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01362049     History of Changes
Other Study ID Numbers: CHRMS 10-045, 5R01HD040909-07
Study First Received: May 24, 2011
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Stabilization exercise
Physical therapy
Rehabilitation
Movement System Impairment exercise

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014