Low Back Pain
Conditions
Brief summary
The goal of this study is to better understand how the thoughts and beliefs of patients with low back pain and their physical therapist influence how much patients benefit from physical therapy. Participants will receive physical therapy as determined by their physical therapist including spinal manipulative therapy, exercise, and education. Participants with low back pain and their physical therapists will complete forms about their thoughts and beliefs about low back pain and treatment.
Interventions
OTHERPhysical therapy
Patients with low back pain will receive a combination of education, spinal manipulative therapy, and exercise as prescribed by their physical therapist
OTHERPhysical therapist provider
Physical therapists will provide a combination of education, spinal manipulative therapy, and exercise to their patients with low back pain participating in the study
Sponsors
Brooks Rehabilitation
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pain between 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. * Meets NIH Task Force criteria for chronic low back pain
Exclusion criteria
* Prior surgery to the lumbosacral spine * Currently pregnant * Not currently receiving spinal manipulative therapy or exercise interventions from another healthcare provider such as a chiropractor or massage therapist. * No neurogenic signs indicating radiculopathy * No red flags of a potentially serious condition (e.g., cauda equina syndrome, fracture, cancer, infection, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 | Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks | Assesses pain intensity using a single item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. This will only be completed by patient participants in the study. |
| NIH Chronic LBP Impact Score | 12 weeks and 26 weeks | Combines results of the Pain Intensity, Physical Function, and Pain Interference PROMIS scores. Scores range from 8 (least impact) to 50 (greatest impact). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptable Symptom State | Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks | The PASS is a self-report, single item question asking: Taking into account the many ways your pain affects your daily life, if you were to remain for the next few months as you are now, would you consider your current state to be satisfactory? with response options being 'Yes' or 'No'. Only patient participants will complete this assessment. |
Countries
United States
Outcome results
None listed