Spinal Control During Functional Activities to Improve Low Back Pain Outcomes

NCT ID: NCT02027623

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-15
• Study Completion Date: 2017-11-30

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.

Detailed Description

For many people, mechanical low back pain (LBP) is a long-term, function-limiting condition rather than a short-term, self-limiting condition. Exercise is one of the primary non-surgical approaches used worldwide for managing LBP. Specifically in people with chronic LBP, exercise has been found to be as efficacious, if not more efficacious than 1) no treatment, 2) usual care, and 3) many other treatments, such as massage or laser therapy. Despite the growing body of evidence for the beneficial effects of exercise, however, there is limited evidence about 1) which exercise is best for which person, 2) how long the effects of different exercises last, 3) which types of exercise people will adhere to, and for how long, and 4) the mechanisms underlying the effects of different types of exercise.

This study aims to address these limitations by directly comparing the effects of 1) exercise to increase strength of the trunk and increase flexibility of the trunk and extremities, and 2) individualized, motor skill training directed at performance of daily functional activities that are painful or limited due to the person's LBP. This study also will examine 1) the effects of a booster phase of intervention, 2) the relationship between adherence to intervention and function, and 3) the relationship between performance of functional activities and function-related outcomes. People with chronic LBP will be randomized to 1) an intervention of strength and flexibility exercise or motor skill training, and 2) a booster or no-booster intervention. Intervention will be provided in 2 phases: 1) initial phase: 6 - 1 hour sessions, once/week for 6 weeks, and 2) booster phase: # of sessions needed to regain independence in home program, beginning 6 months after the initial phase. The investigators will collect 1) measurements of pain, function, disability, and economic outcomes, 2) reports of adherence, and 3) laboratory-based measures of performance of functional activities. People will be followed for 12 months after the initial intervention phase. Three sets of hypotheses are proposed. First, the investigators hypothesize that both interventions will result in improvements in pain, function, disability, and economic outcomes, but that the motor skill training will result in more long lasting improvements than the strength and flexibility exercise. Second, the investigators hypothesize that the effect of a booster phase of intervention will 1) result in longer lasting improvement in function and better adherence than a no-booster intervention, and 2) be greater for motor skill training than for strength and flexibility exercise. Finally, the investigators hypothesize that 1) adherence to motor skill training will be more strongly related to function than will adherence to strength and flexibility exercise, and 2) performance of functional activities by people receiving motor skill training will be more strongly related to function than performance of functional activities by people receiving strength and flexibility exercise.

Conditions

Mechanical Low Back Pain; Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Motor skill training

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.

Group Type: EXPERIMENTAL

Motor skill training

Intervention Type: 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.

Strength and flexibility exercise

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.

Group Type: ACTIVE_COMPARATOR

Strength and flexibility exercise

Intervention Type: 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.

Interventions

Motor skill training

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.

Intervention Type: BEHAVIORAL

Strength and flexibility exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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%
• 3 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

Exclusion Criteria

• 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
• history of neurologic disease which required hospitalization
• active treatment for cancer
• history of unresolved cancer
• pregnancy
• worker's compensation, disability, or litigation case
• Graves' disease
• Marfan syndrome
• Unable to classify low back pain based on clinical examination findings

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Linda Van Dillen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda R Van Dillen, P.T., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Program in Physical Therapy, Washington University Medical School

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36106673 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33369625 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29852151 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2R01HD047709

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201205051

Identifier Type: -

Identifier Source: org_study_id