Mechanical Low Back PainLBPNCT02027623
Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
A study testing Motor skill training and Strength and flexibility exercise in people with Mechanical Low Back Pain and Chronic Low Back Pain, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mechanical Low Back Pain, Chronic Low Back Pain
- What is being tested?
- Motor skill training and Strength and flexibility exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- BMI >30
- any structural spinal deformity including scoliosis, kyphosis, or stenosis
- spinal fracture or dislocation
- low back pain due to trauma
- osteoporosis
- ankylosing spondylitis
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63018-2212
About this study
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.
Read the 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
- Being tested
- Motor skill training, Strength and flexibility exercise
- Keywords
- Mechanical low back pain, Non-specific low back pain, Exercise, Motor skill training
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor skill trainingBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Strength and flexibility exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms.
Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days.
Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst).
Measured: 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
Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms.
Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days.
Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst).
Measured: 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
Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms.
Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days.
Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst).
Measured: 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
Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months.
Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months.
Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months.
Measured: 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
Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months.
Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months.
Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP.
Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP.
Measured: Baseline, completion of initial 6 week intervention phase
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
Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP.
Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP.
Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP.
Procedure: Participants will answer each question by marking the answer as indicated.
Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks.
Measured: Baseline, completion of initial 6 week intervention phase
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
Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP.
Procedure: Participants will answer each question by marking the answer as indicated.
Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP.
Procedure: Participants will answer each question by marking the answer as indicated.
Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase
Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks.
Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment.
Measured: Baseline, completion of initial 6 week intervention phase
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
Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks.
Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks.
Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.
Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.
Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Measured: Baseline, completion of initial 6 week intervention phase
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
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.
Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.
Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.
Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.
Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.
Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.
Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Measured: Baseline, completion of initial 6 week intervention phase
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
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.
Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.
Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.
Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.
Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP.
Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP.
Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP.
Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP.
Measured: Baseline, completion of initial 6 week intervention phase
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
Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP.
Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP.
Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP.
Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP.
Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP.
Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP.
Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP.
Measured: 6 months after initial intervention phase, 12 months after initial intervention phase
Satisfaction With Care (15-75 Points)
Background/Purpose: This questionnaire assesses information about how satisfied a participant feels with the physical therapist and treatment he was provided.
Procedure: Participants will answer each question by marking the answer as indicated. They may only check off one answer per item.
Scoring: Each question is ranked on a 5-point Likert scale. All scores are 1-5, with questions 1, 3, 4, 8, 9, 10 and 13 reverse scored (5-1). The total score is the sum of all of the answers (15-75) with higher scores indicating more satisfaction with care.
Measured: Completion of initial 6 week intervention phase
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained at baseline and immediately after a 6-week intervention phase.
Measured: Baseline, completion of initial 6 week intervention phase
Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained after a 6 week intervention phase and 6 months after intervention.
Measured: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study start15 Jan 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Linda Van Dillen, Washington University School of Medicine
- Investigators
- Linda R Van Dillen, P.T., Ph.D., Principal investigator, Program in Physical Therapy, Washington University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027623
- Sponsor's protocol ID
- 201205051
- Other IDs
- 2R01HD047709
- Acronym
- LBP
- Status last verified
- Aug 2020
- First submitted
- 2 Jan 2014
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36106673van 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.
PubMed 33369625Francois 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.
PubMed 29852151
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
- ClinicalTrials.gov ID
- NCT02027623
- Acronym / sponsor ID
- LBP / 201205051
- Conditions
- Mechanical Low Back Pain, Chronic Low Back Pain
- Keywords
- Mechanical low back pain, Non-specific low back pain, Exercise, Motor skill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Jan 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor skill training | Experimental | Behavioral: Motor skill trainingThe 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. |
| Strength and flexibility exercise | Active comparator | Behavioral: Strength and flexibility exerciseThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- BMI >30
- any structural spinal deformity including scoliosis, kyphosis, or stenosis
- spinal fracture or dislocation
- low back pain due to trauma
- osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor skill trainingThe 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. | Behavioural | Motor skill training |
| Strength and flexibility exerciseExercises 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. | Behavioural | Strength and flexibility exercise |
Primary outcome
Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase
Time frame: Baseline, 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.
Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Time frame: Completion of initial 6 week intervention phase, 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.
Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Time frame: 6 months after initial intervention phase, 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.
26 secondary outcomes
Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
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
Time frame: Baseline, completion of initial 6 week intervention phase
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
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
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
Time frame: Baseline, completion of initial 6 week intervention phase
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
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase
Time frame: Baseline, completion of initial 6 week intervention phase
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
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Time frame: Baseline, completion of initial 6 week intervention phase
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
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Time frame: Baseline, completion of initial 6 week intervention phase
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
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
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
Time frame: Baseline, completion of initial 6 week intervention phase
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
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
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
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
Satisfaction With Care (15-75 Points)
Time frame: Completion of initial 6 week intervention phase
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Time frame: Baseline, completion of initial 6 week intervention phase
Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36106673Lanier 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.
- Derived from this study: PubMed 33369625van 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.
- Derived from this study: PubMed 29852151Francois 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda R Van Dillen, P.T., Ph.D. principal investigator
Program in Physical Therapy, Washington University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor skill training and Strength and flexibility exercise in people with Mechanical Low Back Pain and Chronic Low Back Pain, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase (time frame: Baseline, completion of initial 6 week intervention phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027623, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.