Clinical trial NCT03749564: Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain
Official title: Examining the Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain: Administrative Supplement to UH3AT009293 - Optimization of Spinal Manipulative Therapy (SMT) Protocols
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Opioid Use
Keywords: Spinal Manipulative Therapy
Optimization
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial design examining the outcomes of SMT with varying combinations of co-interventions.
Primary purpose: TREATMENT

Brief summary: This project is a supplement to the parent project (UH3AT009293) entitled "Optimization of Spinal Manipulative Therapy (SMT) Protocols". The goal of the parent project is to examine strategies to optimize SMT treatment protocols for patients with low back pain (LBP). The parent project is investigating mechanistic and clinical outcomes of SMT combined with varying co-interventions. This supplemental project will examine the impact of opioid use on these outcomes.

Detailed description: This supplement expands the parent research project to include three additional Aims and the recruitment of the 70 additional participants. The additional participants will undergo the same assessment and intervention procedures outlined in the parent project to permit leveraging the full cohort to evaluate the supplemental Aims.

The overall objective is to examine the impact of opioid use on patient-centered and mechanistic outcomes related to SMT and explore the impact on SMT followed by various co-interventions. The goal of this research is to better tailor SMT protocols to optimize outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance on opioid pain management among those with LBP. Accomplishing this goal will facilitate future research evaluating the efficacy of non-pharmacologic alternative pain management strategies for individuals with LBP.

Specific Aims to be addressed through this supplement are:

1. Compare baseline psychological, mechanistic and LBP-related characteristics between sub-groups of participants with LBP based on opioid use.
2. Examine the association of opioid use with changes in mechanistic and patient-centered outcomes between a baseline assessment and subsequent assessment after 1-week and completion of a 2-session SMT intervention protocol.
3. Explore the moderating effects of opioid use on mechanistic and patient-centered outcomes obtained 4 weeks following SMT intervention with varied co-intervention components.

Examining these aims as a supplement to the parent project will allow evaluation of whether or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim 2), and will explore if the longer-term effects of the three co-interventions differ between opioid users and non-users. (Aim 3). This research will also compare baseline characteristics between participants who are or are not opioid users (Aim 1).

Eligibility criteria: Inclusion Criteria:

* 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.
* Age 18 - 60 years
* Oswestry disability score \> 20%
* Self-reported

Exclusion Criteria:

* Prior surgery to the lumbosacral spine
* Currently pregnant
* Currently receiving mind-body or exercise treatment for LBP from a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
* 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

Primary outcomes:
measure: Oswestry
timeFrame: 1 week
measure: Pain intensity: 0-10 numeric pain rating
timeFrame: 1 week
Secondary outcomes:
measure: Multifidus Activation
timeFrame: Baseline, 1-week, 4-weeks, 3 months
measure: Spinal Stiffness
timeFrame: Baseline, 1-week, 4-weeks, 3 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, Department of Physical Therapy
state: Utah
Study officials:
References: