Phase 2 Completed N=241 Randomized Double-blind Treatment

Optimization of Spinal Manipulative Therapy Protocols

Low Back Pain

Source: ClinicalTrials.gov NCT02868034 ↗

Enrolled (actual)

241

Serious AEs

0.0%

Results posted

May 2023

Primary outcomePrimary: Spinal Stiffness — 6.20; 6.28; 6.10; 6.07 N/mm — p=0.025

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Spinal Stiffness	6.20; 6.28; 6.10; 6.07; 6.16; 6.06	0.025 sig
PRIMARY Multifidus Activation	12.10; 12.42; 12.0; 12.20; 12.74; 12.10	0.025 sig
SECONDARY Oswestry Disability Index	21.74; 21.64; 21.15; 19.73; 18.97; 18.02	0.025 sig
SECONDARY Pain Intensity	3.13; 2.98; 3.13; 3.10; 2.97; 2.96	0.025 sig

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

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Data sourced from ClinicalTrials.gov (NCT02868034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.