A Phase 2 interventional study of SMT and Mobilizing Exercises in Low Back Pain, sponsored by University of Utah. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by University of Utah · Phase 2, Interventional, and Treatment
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.
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.
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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
Patients receive 2 sessions on SMT during week 1, no additional treatment.
Behavioral: SMT
2 sessions of SMT in week 1 and 6 additional sessions of SMT during weeks 2-4.
Behavioral: SMT · Behavioral: SMT extended
2 sessions of SMT during week 1 and 6 additional sessions of lumbar multifidus activating exercises during weeks 2-4.
Behavioral: SMT · Behavioral: Activation Exercises
2 sessions of SMT during week 1; 6 sessions of spinal mobilizing exercises during weeks 2-4.
Behavioral: SMT · Behavioral: Mobilizing Exercises
2 sessions of SMT during week 1; 6 sessions of lumbar multifidus activating exercises and spinal mobilizing exercises during weeks 2-4.
Behavioral: SMT · Behavioral: Mobilizing Exercises · Behavioral: Activation Exercises
2 sessions of SMT during week 1; 6 sessions of SMT and spinal mobilizing exercises during weeks 2-4.
Behavioral: SMT · Behavioral: Mobilizing Exercises · Behavioral: SMT extended
2 sessions of SMT during week 1; 6 sessions of SMT and lumbar multifidus activating exercises during weeks 2-4.
Behavioral: SMT · Behavioral: Activation Exercises · Behavioral: SMT extended
2 sessions of SMT during week 1; 6 sessions of SMT, multifidus activating and spinal mobilizing exercises during weeks 2-4.
Behavioral: SMT · Behavioral: Mobilizing Exercises · Behavioral: Activation Exercises · Behavioral: SMT extended
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.
Also known as: Spinal Manipulative Therapy
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.
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.
This treatment involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
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.
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.
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.
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.
| Milestone | Phase II - SMT Only | Phase II - SMT Extended | Phase II - SMT With Activation Exercises | Phase II - SMT With Mobilizing Exercises | Phase II - SMT With Mobilizing and Activation Exercises | Phase II - SMT Extended With Mobilizing Exercises | Phase II - SMT Extended With Activation Exercises | Phase II - SMT Extended With Activation and Mobilizing Exercises |
|---|---|---|---|---|---|---|---|---|
| Started | 30 | 29 | 30 | 31 | 30 | 29 | 30 | 32 |
| Completed | 22 | 23 | 26 | 27 | 24 | 26 | 24 | 26 |
| Not completed | 8 | 6 | 4 | 4 | 6 | 3 | 6 | 6 |
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.
| N/mm | SMT Treatment Component | Mobilizing Exercise Component | Activating Exercise Component |
|---|---|---|---|
| Spinal Stiffness measure at 4 weeks | 6.20 (5.98 to 6.41) | 6.28 (6.07 to 6.48) | 6.10 (5.90 to 6.31) |
| Spinal Stiffness measure at 12 weeks | 6.07 (5.85 to 6.28) | 6.16 (5.96 to 6.37) | 6.06 (5.85 to 6.27) |
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.
| percentage | SMT Treatment Component | Mobilizing Exercise Component | Activating Exercise Component |
|---|---|---|---|
| Multifidus Activation 4 weeks | 12.10 (10.20 to 14.0) | 12.42 (10.56 to 14.28) | 12.0 (10.09 to 13.84) |
| Multifidus Activation 12 weeks | 12.20 (10.28 to 14.12) | 12.74 (10.87 to 14.62) | 12.10 (10.22 to 13.97) |
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.
| units on a scale | SMT Treatment Component | Mobilizing Exercise Component | Activating Exercise Component |
|---|---|---|---|
| Oswestry 4 week outcomes | 21.74 (19.23 to 24.25) | 21.64 (19.18 to 24.1) | 21.15 (18.7 to 23.61) |
| Oswestry 12 week outcomes | 19.73 (17.05 to 22.42) | 18.97 (16.33 to 21.62) | 18.02 (15.38 to 20.66) |
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.
| units on a scale | SMT Treatment Component | Mobilizing Exercise Component | Activating Exercise Component |
|---|---|---|---|
| Pain intensity rating 4 weeks | 3.13 (2.76 to 3.51) | 2.98 (2.61 to 3.34) | 3.13 (2.76 to 3.49) |
| Pain intensity rating 12 weeks | 3.10 (2.69 to 3.51) | 2.97 (2.56 to 3.37) | 2.96 (2.56 to 3.37) |
Collected over Adverse events were collected over the 12 week period from baseline to final assessment including both Phase I and Phase II (post-randomization). Events reported by Phase II treatment group may have occurred at any point over the 12-week study period. Among the 32 participants who withdrew before randomization, 4 participants reported 5 adverse events. All events were an increase in symptoms of back pain, spasm or stiffness.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Further Treatment | 0/30 (0%) | 0/30 (0%) | 3/30 (10%) |
| Extended SMT | 0/29 (0%) | 0/29 (0%) | 8/29 (27.6%) |
| Activating Exercise Component Only | 0/30 (0%) | 0/30 (0%) | 9/30 (30%) |
| Mobilizing Exercise Component Only | 0/31 (0%) | 0/31 (0%) | 10/31 (32.3%) |
| SMT With Activating Exercise Component | 0/30 (0%) | 0/30 (0%) | 12/30 (40%) |
| SMT With Mobilizing Exercise Component | 0/29 (0%) | 0/29 (0%) | 7/29 (24.1%) |
| Activating Exercise and Mobilizing Exercise Components | 0/30 (0%) | 0/30 (0%) | 5/30 (16.7%) |
| SMT With Activating Exercise and Mobilizing Exercise Components | 0/32 (0%) | 0/32 (0%) | 13/32 (40.6%) |
| Event | No Further Treatment | Extended SMT | Activating Exercise Component Only | Mobilizing Exercise Component Only | SMT With Activating Exercise Component | SMT With Mobilizing Exercise Component | Activating Exercise and Mobilizing Exercise Components | SMT With Activating Exercise and Mobilizing Exercise Components |
|---|---|---|---|---|---|---|---|---|
| Increased low back symptoms from treatmentMusculoskeletal and connective tissue disorders | 3/30 | 7/29 | 8/30 | 10/31 | 10/30 | 7/29 | 4/30 | 12/32 |
| AccidentInjury, poisoning and procedural complications | 0/30 | 0/29 | 0/30 | 0/31 | 1/30 | 0/29 | 0/30 | 3/32 |
| Surgical proceduresSurgical and medical procedures | 0/30 | 1/29 | 1/30 | 0/31 | 0/30 | 0/29 | 1/30 | 0/32 |
| Reinjured Low BackMusculoskeletal and connective tissue disorders | 0/30 | 0/29 | 0/30 | 1/31 | 1/30 | 0/29 | 1/30 | 1/32 |
315 individuals provided consent and 273 met all eligibility criteria and enrolled in Phase I. Of these 32 (11.7%) withdrew during treatment phase I, leaving 241 participants who completed the 1-week assessment and were randomized to receive additional treatment components in Phase II. The Phase II baseline information is provided.
| Age, Continuous(years) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phase II baseline age | 42.6 ± 11.5 | 36.3 ± 9.8 | 41.1 ± 12.6 | 38.1 ± 10.5 | 41.2 ± 13.7 | 40.4 ± 12 | 40.5 ± 10.5 | 38.8 ± 12.3 | 39.9 ± 11.8 |
| Sex: Female, Male(Participants) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phase II - Baseline Sex — Female | 18 | 20 | 20 | 19 | 18 | 15 | 16 | 18 | 144 |
| Phase II - Baseline Sex — Male | 12 | 9 | 10 | 12 | 12 | 14 | 14 | 14 | 97 |
| Ethnicity (NIH/OMB)(Participants) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 | 3 | 3 | 6 | 0 | 0 | 20 |
| Not Hispanic or Latino | 28 | 25 | 26 | 28 | 27 | 21 | 30 | 32 | 217 |
| Unknown or Not Reported | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 4 |
| Race (NIH/OMB)(Participants) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
| Asian | 2 | 3 | 5 | 4 | 2 | 2 | 3 | 4 | 25 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 1 | 0 | 1 | 1 | 2 | 0 | 7 |
| White | 22 | 19 | 19 | 21 | 24 | 21 | 25 | 25 | 176 |
| More than one race | 1 | 1 | 2 | 3 | 2 | 2 | 0 | 2 | 13 |
| Unknown or Not Reported | 1 | 5 | 3 | 3 | 1 | 3 | 0 | 0 | 16 |
| Chronic LBP(Participants) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Count of participants | 24 | 22 | 23 | 25 | 26 | 20 | 21 | 22 | 183 |
| Oswestry(units on a scale) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 35.7 ± 11.8 | 36.1 ± 17.7 | 33.9 ± 10.0 | 30.6 ± 8.6 | 36.3 ± 11.5 | 29.1 ± 9.5 | 32.7 ± 9.3 | 38.6 ± 12.0 | 34.4 ± 11.8 |
| Pain intensity(units on a scale) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 4.4 ± 1.5 | 4.9 ± 2.0 | 4.8 ± 1.5 | 4.4 ± 1.7 | 4.5 ± 1.5 | 4.4 ± 1.7 | 4.5 ± 1.6 | 4.9 ± 1.7 | 4.6 ± 1.7 |
| Multifidus Activation(percentage increase in thickness) | Phase II - No Further Treatment | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 11.4 ± 9.5 | 9.5 ± 9.4 | 13.6 ± 11.4 | 11.6 ± 8.5 | 14.2 ± 10.9 | 10.7 ± 9.1 | 10.0 ± 8.9 | 11.6 ± 8.2 | 11.2 ± 9.3 |
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University of Utah