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

NCT03749564 | Terminated DMC

• 1 other identifier: 59006084
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Opioid Use

Keywords

Spinal Manipulative Therapy; Optimization

Outcome Measures

Primary Outcomes (2)

• Oswestry

  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.

  1 week

• Pain intensity: 0-10 numeric pain rating

  A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.

  1 week

Secondary Outcomes (2)

• Multifidus Activation

  Baseline, 1-week, 4-weeks, 3 months

• Spinal Stiffness

  Baseline, 1-week, 4-weeks, 3 months

Study Arms (8)

SMT Only

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week.

Behavioral: SMT

SMT extended

EXPERIMENTAL

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.

Behavioral: SMT; Behavioral: Extended SMT

SMT with Activation Exercises

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week. This arm receives 6 additional sessions of activation exercises.

Behavioral: SMT; Behavioral: Activation Exercises

SMT with Mobilizing Exercises

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week. This arm involves 6 additional sessions of mobilizing exercise.

Behavioral: SMT; Behavioral: Mobilizing Exercises

SMT with Mobilizing and Activation Exercises

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week. This arm involves 6 additions sessions including both activation and mobilizing exercises.

Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Mobilizing Exercises

SMT extended with Mobilizing Exercises

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and mobilizing exercises.

Behavioral: SMT; Behavioral: Mobilizing Exercises; Behavioral: Extended SMT

SMT extended with Activation Exercises

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and activation exercises.

Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Extended SMT

SMT extended with Mobilizing and Activation Exercises

EXPERIMENTAL

All patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including SMT, activation and mobilizing exercises.

Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Mobilizing Exercises; Behavioral: Extended SMT

Interventions

SMT BEHAVIORAL

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.

Also known as: spinal manipulative therapy

SMT Only; SMT extended; SMT extended with Activation Exercises; SMT extended with Mobilizing Exercises; SMT extended with Mobilizing and Activation Exercises; SMT with Activation Exercises; SMT with Mobilizing Exercises; SMT with Mobilizing and Activation Exercises

Activation Exercises BEHAVIORAL

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.

SMT extended with Activation Exercises; SMT extended with Mobilizing and Activation Exercises; SMT with Activation Exercises; SMT with Mobilizing and Activation Exercises

Mobilizing Exercises BEHAVIORAL

Mobilizing exercises 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.

SMT extended with Mobilizing Exercises; SMT extended with Mobilizing and Activation Exercises; SMT with Mobilizing Exercises; SMT with Mobilizing and Activation Exercises

Extended SMT BEHAVIORAL

Additional 6 SMT sessions provided

SMT extended; SMT extended with Activation Exercises; SMT extended with Mobilizing Exercises; SMT extended with Mobilizing and Activation Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah, Department of Physical Therapy

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Design precludes blinding of patients or care providers. Research personnel conducting outcomes assessments and the principal investigator are blind to participants' group assignment throughout the study.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Factorial design examining the outcomes of SMT with varying combinations of co-interventions.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: January 17, 2019
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)