This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
refer to arm descriptions
University of Florida
Gainesville, Florida, United States
numeric pain rating scale
0 to 100 with 0= no pain at all to 100= worst pain imaginable
Time frame: Change in baseline at 2 weeks
Oswestry Disability Index
0 to 100 with 0= no perceived disability to 100= greatest perceived disability
Time frame: Change in baseline at 2 weeks
Back Performance Scale
0 to 15 with lower scores indicating better performance
Time frame: Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks
Quantitative Sensory Testing
standardized thermal and pressure stimuli will be applied and participant will rate the pain associated with each using a 0= no pain to 100= worst pain imaginable numeric pain rating scale or a mechanical visual analog scale anchored with no pain and worst pain imaginable
Time frame: change in baseline immediately following spinal manipulative therapy during day 1
Patient Centered Outcome Questionnaire
Participants indicate their usual level, desired level, successful level, and expected level of pain, fatigue, emotional distress, and interference using a 0= none at all to 100= worst imaginable numeric rating scale
Time frame: change in baseline immediately following spinal manipulative therapy during day 1
Working alliance subscale of the Pain Rehabilitation Expectation Scale
Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance
Time frame: change in baseline immediately following spinal manipulative therapy during day 1
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North American Spine Society Lumbar Spine Outcome Assessment
Participants will answer 3 questions: 1) If you had to spend the rest of your life with the low back pain you have right now, how would you feel about it? Scored from 1= very dissatisfied to 5= very satisfied; 2) Would you have the same intervention you received in this study again for low back pain? Scored from 1=Definitely not to 5= definitely yes; 3) . How would you rate the overall results of the intervention you received in this study for low back pain? Scored from 1= Terrible to 6= Excellent
Time frame: 2 weeks
Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale
a brief semi- structured interview
Time frame: 2 weeks