Perspectives on Spinal Manipulative Therapy for Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical therapy, Physical therapist provider.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient and Physical Therapist Perspectives on Spinal Manipulative Therapy for Low Back Pain
Overview
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
- Other Physical therapy
Patients with low back pain will receive a combination of education, spinal manipulative therapy, and exercise as prescribed by their physical therapist - Other Physical 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
Primary outcome measures
- PROMIS-29 [Time frame: Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks]
- NIH Chronic LBP Impact Score [Time frame: 12 weeks and 26 weeks]
Secondary outcome measures (1)
- Patient Acceptable Symptom State [Time frame: Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Florida — Gainesville
Publications
- Beneciuk JM, Bialosky J, Hayes JR, Buzzanca-Fried KE, Rowe R, Cristello S, Harrison T, Vickers R, Shan G. Patient and physical therapist perspectives on spinal manipulative therapy for low back pain and associated clinical outcomes: protocol for a prospective, single-arm intervention study. BMJ Open. 2025 Jul 11;15(7):e099932. doi: 10.1136/bmjopen-2025-099932. PMID 40645636
Identifiers
NCT: NCT06590116 · IRB202301700