Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain

Not Applicable

Terminated

• Conditions: Low Back Pain; Opioid Use
• Interventions: Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Mobilizing Exercises; Behavioral: Extended SMT

• Registration Number: NCT03749564
• Lead Sponsor: University of Utah

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).

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Study Start: 2019-01-17
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
SMT with Mobilizing Exercises	SMT	All patients receive 2 SMT sessions in the first week. This arm involves 6 additional sessions of mobilizing exercise.
SMT with Activation Exercises	Activation Exercises	All patients receive 2 SMT sessions in the first week. This arm receives 6 additional sessions of activation exercises.
SMT with Mobilizing and Activation Exercises	Mobilizing Exercises	All patients receive 2 SMT sessions in the first week. This arm involves 6 additions sessions including both activation and mobilizing exercises.
SMT extended with Mobilizing Exercises	Extended SMT	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and mobilizing exercises.
SMT extended	SMT	All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
SMT extended with Mobilizing Exercises	SMT	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and mobilizing exercises.
SMT Only	SMT	All patients receive 2 SMT sessions in the first week.
SMT extended	Extended SMT	All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
SMT with Mobilizing Exercises	Mobilizing Exercises	All patients receive 2 SMT sessions in the first week. This arm involves 6 additional sessions of mobilizing exercise.
SMT with Activation Exercises	SMT	All patients receive 2 SMT sessions in the first week. This arm receives 6 additional sessions of activation exercises.
SMT with Mobilizing and Activation Exercises	SMT	All patients receive 2 SMT sessions in the first week. This arm involves 6 additions sessions including both activation and mobilizing exercises.
SMT extended with Activation Exercises	Extended SMT	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and activation exercises.
SMT with Mobilizing and Activation Exercises	Activation Exercises	All patients receive 2 SMT sessions in the first week. This arm involves 6 additions sessions including both activation and mobilizing exercises.
SMT extended with Mobilizing and Activation Exercises	SMT	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
SMT extended with Mobilizing and Activation Exercises	Activation Exercises	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
SMT extended with Mobilizing Exercises	Mobilizing Exercises	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and mobilizing exercises.
SMT extended with Mobilizing and Activation Exercises	Mobilizing Exercises	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.
SMT extended with Activation Exercises	SMT	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and activation exercises.
SMT extended with Activation Exercises	Activation Exercises	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and activation exercises.
SMT extended with Mobilizing and Activation Exercises	Extended SMT	All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.

Primary Outcome Measures

Name	Time	Method
Pain intensity: 0-10 numeric pain rating	1 week	A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.
Oswestry	1 week	The Oswestry Index measures back pain-related disability. The scale contains 10 items with a final score ranging from 0-100. Higher numbers indicate more disability.

Secondary Outcome Measures

Name	Time	Method
Multifidus Activation	Baseline, 1-week, 4-weeks, 3 months	Multifidus activation wis measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. The subject is prone. The ultrasound transducer is placed just lateral to midline and angled medially until a parasagittal view of the multifidus is obtained. Images are acquired at each level with the multifidus at rest and during submaximal contraction elicited by the subject lifting the contralateral arm about 2 inches while holding a weight proportional to body weight. Three images in each state are acquired and averaged. Offline multifidus thickness measures are obtained from the distance between the posterior-most aspect of the facet joint inferiorly and the plane between the multifidus and thoracolumbar fascia superior. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed in mm.
Spinal Stiffness	Baseline, 1-week, 4-weeks, 3 months	Spinal stiffness is assessed with a mechanically-assisted indentation device over the spinous processes. Indentation involves advancement of the probe from a 5 N pre-load to 60 N final load maintained for 1 second, then the probe raises automatically. Three indentation trials are performed with mean values used for analysis. Indentation data (force and displacement) are used to calculate stiffness variables. Global stiffness (N) is calculated as the slope of the force displacement curve between 5 - 60 N, representing stiffness of underlying tissues during indentation.

Trial Locations

Locations (1)

University of Utah, Department of Physical Therapy; 🇺🇸 Salt Lake City, Utah, United States