Optimization of Spinal Manipulative Therapy Protocols
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): SMT; Mobilizing Exercises; Activation Exercises; SMT extended
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Spinal Manipulative Therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Spinal Manipulation; Exercise