Low Back Pain
Conditions
Brief summary
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.
Interventions
PROCEDUREspinal manipulative therapy
refer to arm descriptions
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain; * Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour; * Appropriate for conservative treatment for low back pain.
Exclusion criteria
* Non-English speaking; * Systemic medical conditions know to affect sensation (e.g. diabetes); * History of lumbar surgery or fracture within the past 6 months; * Received spinal manipulative therapy for treatment of low back pain within past 6 months; * Current or history of chronic pain condition other than low back pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numeric pain rating scale | Change in baseline at 2 weeks | 0 to 100 with 0= no pain at all to 100= worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back Performance Scale | Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks | 0 to 15 with lower scores indicating better performance |
| Quantitative Sensory Testing | change in baseline immediately following spinal manipulative therapy during day 1 | 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 |
| Patient Centered Outcome Questionnaire | change in baseline immediately following spinal manipulative therapy during day 1 | 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 |
| Oswestry Disability Index | Change in baseline at 2 weeks | 0 to 100 with 0= no perceived disability to 100= greatest perceived disability |
| North American Spine Society Lumbar Spine Outcome Assessment | 2 weeks | 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 |
| Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale | 2 weeks | a brief semi- structured interview |
| Working alliance subscale of the Pain Rehabilitation Expectation Scale | change in baseline immediately following spinal manipulative therapy during day 1 | Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance |
Countries
United States
Outcome results
None listed