Optimization of Spinal Manipulative Therapy Protocols
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: SMT; Mobilizing Exercises; Activation Exercises; SMT extended
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Low Back Pain; Spinal Manipulation; Exercise

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.
    

Eligibility criteria:

        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