An interventional study of spinal manipulative therapy in Low Back Pain, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will receive spinal manipulative therapy provided by a practitioner interacting in a warm and friendly way who is free to respond to participant conversation. Participants in this group will receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
Procedure: spinal manipulative therapy
Participants in this group will receive spinal manipulative therapy provided by a practitioner engaging in minimal interaction. Participants in this group will not receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
Procedure: spinal manipulative therapy
refer to arm descriptions
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florida