Optimization of Spinal Manipulative Therapy Protocols
1 other identifier
interventional
273
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 low-back-pain
Started Feb 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2019
CompletedResults Posted
Study results publicly available
May 17, 2023
CompletedMay 17, 2023
April 1, 2023
1.9 years
August 11, 2016
December 2, 2020
April 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Spinal Stiffness
Spinal stiffness is assessed with the VerteTrack device that applies a vertical load along the lumbar spine of a prone participant. The indenter houses a sensor to provide continuous, real-time quantification of spinal deformation in response to a defined load. Stiffness was determined as the ratio of the maximum applied force to the resultant displacement in N/mm. Higher numbers indicate greater amounts of stiffness.
Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Multifidus Activation
Multifidus activation was measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. Images are acquired with the multifidus at rest and during submaximal contraction. Three images in each state are acquired and averaged. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed as a percentage change. Greater numbers indicate higher muscle activation.
Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Secondary Outcomes (2)
Oswestry Disability Index
Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Pain Intensity
Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Study Arms (8)
SMT Only
EXPERIMENTALPatients receive 2 sessions on SMT during week 1, no additional treatment.
SMT extended
EXPERIMENTAL2 sessions of SMT in week 1 and 6 additional sessions of SMT during weeks 2-4.
SMT with Activation Exercises
EXPERIMENTAL2 sessions of SMT during week 1 and 6 additional sessions of lumbar multifidus activating exercises during weeks 2-4.
SMT with Mobilizing Exercises
EXPERIMENTAL2 sessions of SMT during week 1; 6 sessions of spinal mobilizing exercises during weeks 2-4.
SMT with Mobilizing and Activation Exercises
EXPERIMENTAL2 sessions of SMT during week 1; 6 sessions of lumbar multifidus activating exercises and spinal mobilizing exercises during weeks 2-4.
SMT extended with Mobilizing Exercises
EXPERIMENTAL2 sessions of SMT during week 1; 6 sessions of SMT and spinal mobilizing exercises during weeks 2-4.
SMT extended with Activation Exercises
EXPERIMENTAL2 sessions of SMT during week 1; 6 sessions of SMT and lumbar multifidus activating exercises during weeks 2-4.
SMT extended with Activation and Mobilizing Exercises
EXPERIMENTAL2 sessions of SMT during week 1; 6 sessions of SMT, multifidus activating and spinal mobilizing exercises during weeks 2-4.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- University of Albertacollaborator
Study Sites (2)
University of Utah, Department of Physical Therapy
Salt Lake City, Utah, 84112, United States
University of Alberta
Edmonton, Alberta, Canada
Related Publications (1)
Fritz JM, Sharpe JA, Lane E, Santillo D, Greene T, Kawchuk G. Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial. Trials. 2018 Jun 4;19(1):306. doi: 10.1186/s13063-018-2692-6.
PMID: 29866131DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Julie Fritz
- Organization
- University of Utah
Study Officials
- PRINCIPAL INVESTIGATOR
Julie M Fritz, PhD, PT
University of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 16, 2016
Study Start
February 22, 2017
Primary Completion
January 12, 2019
Study Completion
January 12, 2019
Last Updated
May 17, 2023
Results First Posted
May 17, 2023
Record last verified: 2023-04