Low Back Pain
Conditions
Keywords
Low Back Pain, Spinal Manipulation, Exercise
Brief summary
Research on spinal manipulative therapy for individuals with low back pain has been hampered by a lack of understanding of which of the physiologic effects produced by spinal manipulation are related to clinical benefit, and how these effects can be used to optimize treatment outcomes. Prior research has identified physiologic effects that relate to the clinical benefits from spinal manipulation treatment. The goal of this project is to examine strategies to use these effects to identify optimized treatment protocols. The results of this project will provide critical information for future clinical trials related to spinal manipulation.
Detailed description
Low back pain (LBP) is a common and costly condition. Spinal manipulative therapy (SMT) is a common mind body intervention for individuals with LBP. Although SMT for LBP has been examined in numerous clinical studies, the literature on SMT remains unclear and even contradictory as to the effectiveness of this treatment. Studies that have supported SMT have generally found relatively small treatment effects. Many reasons have been offered for the inconsistent research literature and small effect sizes of SMT. A primary rationale offered is that the SMT protocols used in clinical research are not optimal, primarily due to a lack of understanding of the underlying mechanisms explaining the clinical benefits of SMT realized by some patients with LBP. The prior work of this research team has identified two mechanisms explaining the therapeutic effects of SMT. These effects are a reduction in spinal stiffness and improved activation of the lumbar multifidus muscle. This research has also developed accurate, non-invasive methods to measure these effects and their response to SMT. The model identifying these two mechanisms has been validated in a second patient sample. The overall goal of this proposal is to optimize SMT treatment protocols for patients with LBP. The optimization strategy in this study will evaluate SMT combined with other treatments known to modulate the same signals that underlie the clinical effects of SMT assessing both mechanistic (stiffness, lumbar multifidus activation) and patient-centered (function and pain) outcomes. This project will use innovative methodology to efficiently evaluate the effects of various individual treatment components towards an overall effect; identifying which components are contributing to the target outcomes and which, if any, may be discarded. All participants will be provided 2 sessions of SMT, and then will be randomized to a treatment group for an additional 3 weeks using a factorial design and stratified by responder status in order to evaluate different combinations of intervention components (muscle activation exercise, spinal mobilizing exercise, additional SMT) that work on the same pathways that modulate the same effects (spinal stiffness and muscle activation). Outcomes will include spinal stiffness and muscle activation measures as well as patient-reported outcomes assessed at baseline, and after 1 week, 4 weeks and 3 months. Results of this project will provide optimized SMT protocols that will be ready for application in future randomized controlled trials examining the efficacy and effectiveness of SMT.
Interventions
BEHAVIORALSMT
All patients receive 2 SMT sessions in the first week. The subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a pop) occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort.
BEHAVIORALMobilizing Exercises
Mobilizing exercises will include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
BEHAVIORALActivation Exercises
Activation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
BEHAVIORALSMT extended
This treatment involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
Sponsors
University of Alberta
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
I. Pain between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region. II. Age 18 - 60 years III. Oswestry disability score \> 20%
Exclusion criteria
I. Prior surgery to the lumbosacral spine II. Currently pregnant III. Currently receiving mind-body or exercise treatment for LBP from a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.) IV. Neurogenic signs including any of the following: positive ipsi- or contra-lateral straight leg raise test; reflex, sensory, or strength deficit in a pattern consistent with lumbar nerve root compression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Stiffness | Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses. | Spinal stiffness is assessed with the VerteTrack device that applies a vertical load along the lumbar spine of a prone participant. The indenter houses a sensor to provide continuous, real-time quantification of spinal deformation in response to a defined load. Stiffness was determined as the ratio of the maximum applied force to the resultant displacement in N/mm. Higher numbers indicate greater amounts of stiffness. |
| Multifidus Activation | Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses. | Multifidus activation was measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. Images are acquired with the multifidus at rest and during submaximal contraction. Three images in each state are acquired and averaged. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed as a percentage change. Greater numbers indicate higher muscle activation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses. | The Oswestry Disability Index measures back pain-related disability. The scale contains 10 items with a minimum score of zero and maximum score of 100. Higher numbers indicate more disability. There are no subscales. |
| Pain Intensity | Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses. | A 0-10 numeric pain rating is used to assess pain intensity. The minimum score is zero, maximum score is 10. Higher numbers indicate greater pain intensity. There are no subscales. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Participants were enrolled into Phase I of the study (enrollment - 1 week). After the completion of Phase I participants were randomized to an intervention arm for Phase II (1 week - 12 weeks). Baseline data are provided from the 1-week assessment, which corresponds to the time of randomization and beginning of Phase II.
Participants by arm
| Arm | Count |
|---|---|
| Phase II - No Further Treatment Phase II baseline values from the 1-weekassessment for participants who did not receive additional treatment in Phase II | 30 |
| Phase II - Extended SMT Only Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of additional SMT in Phase II | 29 |
| Phase II - Activating Exercise Component Only Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of activating exercises only in Phase II | 30 |
| Phase II - Mobilizing Exercise Component Only Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of mobilizing exercises only in Phase II | 31 |
| Phase II i SMT and Activating Exercise Component Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of activating exercises and SMT in Phase II | 30 |
| Phase II - - SMT With Mobilizing Exercise Component Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of mobilizing exercises and SMT in Phase II | 29 |
| Phase II - Activating Exercise and Mobilizing Exercise Components Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of mobilizing exercises and activating exercises in Phase II | 30 |
| Phase II - SMT With Mobilizing Exercise and Activating Exercise Phase II baseline values from the 1-weekassessment for participants who received 2 sessions per week of mobilizing exercises and activating exercises and SMT in Phase II | 32 |
| Total | 241 |
Baseline characteristics
| Characteristic | Total | Phase II - Extended SMT Only | Phase II - Activating Exercise Component Only | Phase II - Mobilizing Exercise Component Only | Phase II i SMT and Activating Exercise Component | Phase II - - SMT With Mobilizing Exercise Component | Phase II - Activating Exercise and Mobilizing Exercise Components | Phase II - SMT With Mobilizing Exercise and Activating Exercise | Phase II - No Further Treatment |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Phase II baseline age | 39.9 years STANDARD_DEVIATION 11.8 | 36.3 years STANDARD_DEVIATION 9.8 | 41.1 years STANDARD_DEVIATION 12.6 | 38.1 years STANDARD_DEVIATION 10.5 | 41.2 years STANDARD_DEVIATION 13.7 | 40.4 years STANDARD_DEVIATION 12 | 40.5 years STANDARD_DEVIATION 10.5 | 38.8 years STANDARD_DEVIATION 12.3 | 42.6 years STANDARD_DEVIATION 11.5 |
| Chronic LBP | 183 Participants | 22 Participants | 23 Participants | 25 Participants | 26 Participants | 20 Participants | 21 Participants | 22 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 217 Participants | 25 Participants | 26 Participants | 28 Participants | 27 Participants | 21 Participants | 30 Participants | 32 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Multifidus Activation | 11.2 percentage increase in thickness STANDARD_DEVIATION 9.3 | 9.5 percentage increase in thickness STANDARD_DEVIATION 9.4 | 13.6 percentage increase in thickness STANDARD_DEVIATION 11.4 | 11.6 percentage increase in thickness STANDARD_DEVIATION 8.5 | 14.2 percentage increase in thickness STANDARD_DEVIATION 10.9 | 10.7 percentage increase in thickness STANDARD_DEVIATION 9.1 | 10.0 percentage increase in thickness STANDARD_DEVIATION 8.9 | 11.6 percentage increase in thickness STANDARD_DEVIATION 8.2 | 11.4 percentage increase in thickness STANDARD_DEVIATION 9.5 |
| Oswestry | 34.4 units on a scale STANDARD_DEVIATION 11.8 | 36.1 units on a scale STANDARD_DEVIATION 17.7 | 33.9 units on a scale STANDARD_DEVIATION 10 | 30.6 units on a scale STANDARD_DEVIATION 8.6 | 36.3 units on a scale STANDARD_DEVIATION 11.5 | 29.1 units on a scale STANDARD_DEVIATION 9.5 | 32.7 units on a scale STANDARD_DEVIATION 9.3 | 38.6 units on a scale STANDARD_DEVIATION 12 | 35.7 units on a scale STANDARD_DEVIATION 11.8 |
| Pain intensity | 4.6 units on a scale STANDARD_DEVIATION 1.7 | 4.9 units on a scale STANDARD_DEVIATION 2 | 4.8 units on a scale STANDARD_DEVIATION 1.5 | 4.4 units on a scale STANDARD_DEVIATION 1.7 | 4.5 units on a scale STANDARD_DEVIATION 1.5 | 4.4 units on a scale STANDARD_DEVIATION 1.7 | 4.5 units on a scale STANDARD_DEVIATION 1.6 | 4.9 units on a scale STANDARD_DEVIATION 1.7 | 4.4 units on a scale STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 3 Participants | 5 Participants | 4 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 5 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 176 Participants | 19 Participants | 19 Participants | 21 Participants | 24 Participants | 21 Participants | 25 Participants | 25 Participants | 22 Participants |
| Sex: Female, Male Phase II - Baseline Sex Female | 144 Participants | 20 Participants | 20 Participants | 19 Participants | 18 Participants | 15 Participants | 16 Participants | 18 Participants | 18 Participants |
| Sex: Female, Male Phase II - Baseline Sex Male | 97 Participants | 9 Participants | 10 Participants | 12 Participants | 12 Participants | 14 Participants | 14 Participants | 14 Participants | 12 Participants |
| Spinal Stiffness | 6.0 N/mm STANDARD_DEVIATION 1.4 | 5.8 N/mm STANDARD_DEVIATION 1.4 | 5.9 N/mm STANDARD_DEVIATION 1.3 | 6.3 N/mm STANDARD_DEVIATION 1.1 | 5.7 N/mm STANDARD_DEVIATION 1.2 | 5.9 N/mm STANDARD_DEVIATION 1.4 | 5.7 N/mm STANDARD_DEVIATION 1.1 | 5.9 N/mm STANDARD_DEVIATION 1 | 6.0 N/mm STANDARD_DEVIATION 1.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 29 | 0 / 30 | 0 / 31 | 0 / 30 | 0 / 29 | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 3 / 30 | 8 / 29 | 9 / 30 | 10 / 31 | 12 / 30 | 7 / 29 | 5 / 30 | 13 / 32 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 | 0 / 30 | 0 / 31 | 0 / 30 | 0 / 29 | 0 / 30 | 0 / 32 |
Outcome results
Primary
Multifidus Activation
Multifidus activation was measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. Images are acquired with the multifidus at rest and during submaximal contraction. Three images in each state are acquired and averaged. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed as a percentage change. Greater numbers indicate higher muscle activation.
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Population: Results were examined based on the main effects and interactions among the 3 treatment components in the factorial study design (SMT, Mobilizing Exercise, Activating Exercise). Scores were missing for participants in the SMT group (n=21 at 4 weeks and 12 weeks), Mobilizing exercise (n=14 at 4 weeks and n=19 at 12 weeks), and Activating exercise (n=16 at 4 weeks and n=22 at 12 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SMT Treatment Component | Multifidus Activation | Multifidus Activation 4 weeks | 12.10 percentage |
| SMT Treatment Component | Multifidus Activation | Multifidus Activation 12 weeks | 12.20 percentage |
| Mobilizing Exercise Component | Multifidus Activation | Multifidus Activation 4 weeks | 12.42 percentage |
| Mobilizing Exercise Component | Multifidus Activation | Multifidus Activation 12 weeks | 12.74 percentage |
| Activating Exercise Component | Multifidus Activation | Multifidus Activation 4 weeks | 12.0 percentage |
| Activating Exercise Component | Multifidus Activation | Multifidus Activation 12 weeks | 12.10 percentage |
Comparison: SMT Component Main Effects at 4 weeksp-value: 0.02597.5% CI: [-2.67, 1.52]Mixed Models Analysis
Comparison: SMT Component Main Effects at 12 weeksp-value: 0.02597.5% CI: [-2.76, 2.02]Mixed Models Analysis
Comparison: Mobilizing Component Main Effects at 4 weeksp-value: 0.02597.5% CI: [-2.03, 2.16]Mixed Models Analysis
Comparison: Mobilizing Component Main Effects at 12 weeksp-value: 0.02597.5% CI: [-1.68, 3.11]Mixed Models Analysis
Comparison: Activating Exercise Component at 4 weeksp-value: 0.02597.5% CI: [-2.94, 1.25]Mixed Models Analysis
Comparison: Activating Exercise Component at 12 weeksp-value: 0.02597.5% CI: [-2.97, 1.82]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-3.39, 4.99]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-5.47, 4.11]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-5.75, 2.63]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-3.37, 6.21]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-4.63, 3.75]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-2.77, 6.8]Mixed Models Analysis
Comparison: Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-4.37, 4.01]Mixed Models Analysis
Comparison: Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-4.22, 5.35]Mixed Models Analysis
Primary
Spinal Stiffness
Spinal stiffness is assessed with the VerteTrack device that applies a vertical load along the lumbar spine of a prone participant. The indenter houses a sensor to provide continuous, real-time quantification of spinal deformation in response to a defined load. Stiffness was determined as the ratio of the maximum applied force to the resultant displacement in N/mm. Higher numbers indicate greater amounts of stiffness.
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Population: Results were examined based on the main effects and interactions among the 3 treatment components in the factorial study design (SMT, Mobilizing Exercise, Activating Exercise). Scores were missing for participants in the SMT group (n=21 at 4 weeks and 12 weeks), Mobilizing exercise (n=14 at 4 weeks and n=19 at 12 weeks), and Activating exercise (n=16 at 4 weeks and n=22 at 12 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SMT Treatment Component | Spinal Stiffness | Spinal Stiffness measure at 4 weeks | 6.20 N/mm |
| SMT Treatment Component | Spinal Stiffness | Spinal Stiffness measure at 12 weeks | 6.07 N/mm |
| Mobilizing Exercise Component | Spinal Stiffness | Spinal Stiffness measure at 12 weeks | 6.16 N/mm |
| Mobilizing Exercise Component | Spinal Stiffness | Spinal Stiffness measure at 4 weeks | 6.28 N/mm |
| Activating Exercise Component | Spinal Stiffness | Spinal Stiffness measure at 12 weeks | 6.06 N/mm |
| Activating Exercise Component | Spinal Stiffness | Spinal Stiffness measure at 4 weeks | 6.10 N/mm |
Comparison: SMT Component Main Effects at 4 weeksp-value: 0.02597.5% CI: [-0.26, 0.22]Mixed Models Analysis
Comparison: SMT Component Main Effects after 12 weeksp-value: 0.02597.5% CI: [-0.43, 0.09]Mixed Models Analysis
Comparison: Mobilizing Exercise Treatment Component Main Effects at 4 weeksp-value: 0.02597.5% CI: [-0.11, 0.38]Mixed Models Analysis
Comparison: Mobilizing Exercise Component Main Effects at 12 weeksp-value: 0.02597.5% CI: [-0.23, 0.29]Mixed Models Analysis
Comparison: Activating Exercise Component Main Effect at 4 weeksp-value: 0.02597.5% CI: [-0.45, 0.04]Mixed Models Analysis
Comparison: Activating Exercise Component Main Effect at 12 weeksp-value: 0.02597.5% CI: [-0.45, 0.07]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.66, 0.32]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-0.62, 0.42]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.36, 0.62]Mixed Models Analysis
p-value: 0.02597.5% CI: [-0.02, 1.02]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.66, 0.32]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-0.13, 0.91]Mixed Models Analysis
Comparison: Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.24, 0.74]Mixed Models Analysis
Comparison: Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-0.12, 0.92]Mixed Models Analysis
Secondary
Oswestry Disability Index
The Oswestry Disability Index measures back pain-related disability. The scale contains 10 items with a minimum score of zero and maximum score of 100. Higher numbers indicate more disability. There are no subscales.
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Population: Results were examined based on the main effects and interactions among the 3 treatment components in the factorial study design (SMT, Mobilizing Exercise, Activating Exercise). Scores were missing for participants in the SMT group (n=21 at 4 weeks and 12 weeks), Mobilizing exercise (n=14 at 4 weeks and n=19 at 12 weeks), and Activating exercise (n=16 at 4 weeks and n=22 at 12 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SMT Treatment Component | Oswestry Disability Index | Oswestry 4 week outcomes | 21.74 units on a scale |
| SMT Treatment Component | Oswestry Disability Index | Oswestry 12 week outcomes | 19.73 units on a scale |
| Mobilizing Exercise Component | Oswestry Disability Index | Oswestry 12 week outcomes | 18.97 units on a scale |
| Mobilizing Exercise Component | Oswestry Disability Index | Oswestry 4 week outcomes | 21.64 units on a scale |
| Activating Exercise Component | Oswestry Disability Index | Oswestry 12 week outcomes | 18.02 units on a scale |
| Activating Exercise Component | Oswestry Disability Index | Oswestry 4 week outcomes | 21.15 units on a scale |
Comparison: SMT Treatment Component Main Effect at 4-weeksp-value: 0.02597.5% CI: [-4, 1.68]Mixed Models Analysis
Comparison: SMT Treatment Component Main Effect at 12-weeksp-value: 0.02597.5% CI: [-3.46, 3.07]Mixed Models Analysis
Comparison: Mobilizing Exercise Treatment Component main effect after 4-weeksp-value: 0.02597.5% CI: [-4.2, 1.48]Mixed Models Analysis
Comparison: Mobilizing Exercise Treatment Component main effect after 12-weeksp-value: 0.02597.5% CI: [-4.99, 1.55]Mixed Models Analysis
Comparison: Activating Exercise Treatment Component main effect after 4-weeksp-value: 0.02597.5% CI: [-5.18, 0.5]Mixed Models Analysis
Comparison: Activating Treatment Component Main Effect after 12-weeksp-value: 0.02597.5% CI: [-6.89, -0.35]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-2.45, 8.92]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-2.19, 10.87]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-5.12, 6.25]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-7.2, 5.87]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-1.04, 10.32]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-5.04, 8.02]Mixed Models Analysis
Comparison: 3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-6.54, 4.82]Mixed Models Analysis
Comparison: 3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-6.5, 6.57]Mixed Models Analysis
Secondary
Pain Intensity
A 0-10 numeric pain rating is used to assess pain intensity. The minimum score is zero, maximum score is 10. Higher numbers indicate greater pain intensity. There are no subscales.
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Population: Results were examined based on the main effects and interactions among the 3 treatment components in the factorial study design (SMT, Mobilizing Exercise, Activating Exercise). Scores were missing for participants in the SMT group (n=21 at 4 weeks and 12 weeks), Mobilizing exercise (n=14 at 4 weeks and n=19 at 12 weeks), and Activating exercise (n=16 at 4 weeks and n=22 at 12 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SMT Treatment Component | Pain Intensity | Pain intensity rating 4 weeks | 3.13 units on a scale |
| SMT Treatment Component | Pain Intensity | Pain intensity rating 12 weeks | 3.10 units on a scale |
| Mobilizing Exercise Component | Pain Intensity | Pain intensity rating 4 weeks | 2.98 units on a scale |
| Mobilizing Exercise Component | Pain Intensity | Pain intensity rating 12 weeks | 2.97 units on a scale |
| Activating Exercise Component | Pain Intensity | Pain intensity rating 4 weeks | 3.13 units on a scale |
| Activating Exercise Component | Pain Intensity | Pain intensity rating 12 weeks | 2.96 units on a scale |
Comparison: SMT Treatment Component Main Effect at 4-weeksp-value: 0.02597.5% CI: [-0.6, 0.32]Mixed Models Analysis
Comparison: SMT Treatment Component Main Effects at 12 weeksp-value: 0.02597.5% CI: [-0.44, 0.61]Mixed Models Analysis
Comparison: Mobilizing Exercise Component Main Effects at 4 weeksp-value: 0.02597.5% CI: [-0.92, 0]Mixed Models Analysis
Comparison: Mobilizing Exercise Component Main Effects at 12 weeksp-value: 0.02597.5% CI: [-0.7, 0.34]Mixed Models Analysis
Comparison: Activating Exercise Component Main Effects at 4 weeksp-value: 0.02597.5% CI: [-0.62, 0.3]Mixed Models Analysis
Comparison: Activating Exercise Component Main Effects at 12 weeksp-value: 0.02597.5% CI: [-0.71, 0.33]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.54, 1.3]Mixed Models Analysis
Comparison: Pairwise interaction effect of mobilizing and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-0.6, 1.49]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.8, 1.04]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and activating exercise components after 12 weeksp-value: 0.02597.5% CI: [-0.81, 1.28]Mixed Models Analysis
p-value: 0.02597.5% CI: [-0.03, 1.81]Mixed Models Analysis
Comparison: Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-1.07, 1.02]Mixed Models Analysis
Comparison: 3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeksp-value: 0.02597.5% CI: [-0.21, 1.63]Mixed Models Analysis
Comparison: 3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeksp-value: 0.02597.5% CI: [-1.05, 1.04]Mixed Models Analysis