Optimization of Spinal Manipulative Therapy Protocols

PHASE2CompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

January 12, 2019

Study Completion Date

January 12, 2019

Conditions
Low Back Pain
Interventions
BEHAVIORAL

SMT

"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."

BEHAVIORAL

Mobilizing Exercises

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.

BEHAVIORAL

Activation Exercises

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.

BEHAVIORAL

SMT extended

This treatment involves 6 additional SMT sessions. Each SMT session is conducted as described previously.

Trial Locations (2)

84112

University of Utah, Department of Physical Therapy, Salt Lake City

Unknown

University of Alberta, Edmonton

All Listed Sponsors
collaborator

University of Alberta

OTHER

lead

University of Utah

OTHER

NCT02868034 - Optimization of Spinal Manipulative Therapy Protocols | Biotech Hunter | Biotech Hunter