Clinical trial NCT02027623: Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
Official title: Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Chronic Low Back Pain
Keywords: Mechanical low back pain
Non-specific low back pain
Exercise
Motor skill training
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-01-06
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase
timeFrame: Baseline, 6 months after initial intervention phase
measure: 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
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Satisfaction With Care (15-75 Points)
timeFrame: Completion of initial 6 week intervention phase
measure: Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
Other outcomes:
measure: Adherence to Home Program (0-100%) at Completion of Initial 6 Week Intervention Phase
timeFrame: completion of initial 6 week intervention phase
measure: Adherence to Home Program (0-100%) at 6 Months After Completion of Initial Intervention Phase
timeFrame: 6 months after initial intervention phase
measure: Adherence to Home Program (0-100%) at 12 Months After Initial Intervention Phase
timeFrame: 12 months after initial intervention phase
measure: Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
measure: Treatment Preference Assessment Measure, Effectiveness Subscale (0-4 Points)
timeFrame: Baseline
measure: Treatment Preference Assessment Measure, Acceptability Subscale (0-4 Points)
timeFrame: Baseline
measure: Treatment Preference Assessment Measure, Suitability/Appropriateness Subscale (0-4 Points)
timeFrame: Baseline
measure: Treatment Preference Assessment Measure, Convenience Subscale (0-4 Points)
timeFrame: Baseline
measure: Change in Direct and Indirect Health Care Costs (Estimated Costs) From Baseline to Completion of Initial 6 Week Intervention Phase
timeFrame: Baseline, completion of initial 6 week intervention phase
measure: Change in Direct and Indirect Healthcare Costs (Estimated Costs) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
timeFrame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
measure: Change in Direct and Indirect Healthcare Costs (Estimated Costs) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
timeFrame: 6 months after initial intervention phase, 12 months after initial intervention phase
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Program in Physical Therapy, Washington University Medical School
name: Linda R Van Dillen, P.T., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.