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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
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.
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.
Washington University School of Medicine
St Louis, Missouri, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after initial intervention phase, 12 months after initial intervention phase
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).
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
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).
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
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).
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
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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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase