Spinal Control During Functional Activities to Improve Low Back Pain Outcomes

NCT02027623 | Completed Results DMC

• 2 other identifiers: 2012050512R01HD047709
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is one of the primary interventions used with people with chronic, mechanical low back pain. It is unknown, however, which exercise is best for which person, which exercises a person will adhere to and for how long, and the effect of adhering to a specific type of exercise on how the person functions, particularly in the long run. The purpose of this study is to examine if the short- and long-term effects are different between 1) commonly prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized practice in daily functional activities that are difficult or painful to perform. Adherence to the different interventions, the relationship between adherence and outcomes,as well as the effect of a booster intervention also will be examined.

Conditions

Mechanical Low Back Pain; Chronic Low Back Pain

Keywords

Mechanical low back pain; Non-specific low back pain; Exercise; Motor skill training

Outcome Measures

Primary Outcomes (3)

• Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase

  Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.

  Baseline, completion of initial 6 week intervention phase

• Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase

  Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.

  Completion of initial 6 week intervention phase, 6 months after initial intervention phase

• Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase

  Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.

  6 months after initial intervention phase, 12 months after initial intervention phase

Secondary Outcomes (26)

• Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase

  Baseline, completion of initial 6 week intervention phase

• Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase

  Completion of initial 6 week intervention phase, 6 months after initial intervention phase

• Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase

  6 months after initial intervention phase, 12 months after initial intervention phase

• Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase

  Baseline, 6 months after initial intervention phase

• Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase

  6 months after initial intervention phase, 12 months after initial intervention phase

Other Outcomes (16)

• Adherence to Home Program (0-100%) at Completion of Initial 6 Week Intervention Phase

  completion of initial 6 week intervention phase

• Adherence to Home Program (0-100%) at 6 Months After Completion of Initial Intervention Phase

  6 months after initial intervention phase

• Adherence to Home Program (0-100%) at 12 Months After Initial Intervention Phase

  12 months after initial intervention phase

Study Arms (2)

Motor skill training

EXPERIMENTAL

The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.

Behavioral: Motor skill training

Strength and flexibility exercise

ACTIVE COMPARATOR

The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.

Behavioral: Strength and flexibility exercise

Interventions

Motor skill training BEHAVIORAL

The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment will be provided as needed.

Motor skill training

Strength and flexibility exercise BEHAVIORAL

Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.

Strength and flexibility exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic low back pain for a minimum of 12 months
• currently experiencing low back pain symptoms but not in a recurrence or an acute flare-up
• Modified Oswestry Disability Index score of ≥ 20%
• or more functional activities limited due to low back pain
• able to stand and walk without assistance
• able to understand and sign a consent form

You may not qualify if:

• BMI \>30
• any structural spinal deformity including scoliosis, kyphosis, or stenosis
• spinal fracture or dislocation
• low back pain due to trauma
• osteoporosis
• ankylosing spondylitis
• rheumatoid arthritis
• fibromyalgia
• symptomatic disc herniation
• spondylolisthesis
• 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 low back pain other than the lumbar spine, e.g., hip joint

Sponsors & Collaborators

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

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63018-2212, United States

Location

Related Publications (3)

• Lanier VM, Lohse KR, Hooker QL, Francois SJ, van Dillen LR. Treatment preference changes after exposure to treatment in adults with chronic low back pain. PM R. 2023 Jul;15(7):817-827. doi: 10.1002/pmrj.12897. Epub 2022 Oct 24.

  PMID: 36106673 DERIVED

• van Dillen LR, Lanier VM, Steger-May K, Wallendorf M, Norton BJ, Civello JM, Czuppon SL, Francois SJ, Roles K, Lang CE. Effect of Motor Skill Training in Functional Activities vs Strength and Flexibility Exercise on Function in People With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2021 Apr 1;78(4):385-395. doi: 10.1001/jamaneurol.2020.4821.

  PMID: 33369625 DERIVED

• Francois SJ, Lanier VM, Marich AV, Wallendorf M, Van Dillen LR. A Cross-Sectional Study Assessing Treatment Preference of People With Chronic Low Back Pain. Arch Phys Med Rehabil. 2018 Dec;99(12):2496-2503. doi: 10.1016/j.apmr.2018.04.027. Epub 2018 May 28.

  PMID: 29852151 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Linda van Dillen, PT, PhD, FAPTA; Research Division Director
• Organization: Washington University

vandillenl@wustl.edu

314-286-1427

Study Officials

• Linda R Van Dillen, P.T., Ph.D.

  Program in Physical Therapy, Washington University Medical School

  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: January 2, 2014
• First Posted: January 6, 2014
• Study Start: January 15, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 21, 2020
• Results First Posted: July 10, 2019

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)