Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06590116

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Physical therapy

Physical therapist provider

Study Details

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.

Conditions

Low Back Pain

Study ID

NCT06590116

Start date

Dec 17, 2024

Status verified date

Jan, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Patients

Patients seeking physical therapy for low back pain

other: Physical therapists

Physical therapists treating enrolled patients

Interventions

Physical therapy

Patients with low back pain will receive a combination of education, spinal manipulative therapy, and exercise as prescribed by their physical therapist

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 measure

  • 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 ]

Central Contacts and Locations

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Joel E Bialosky, PhD

352-733-1162bialosky@phhp.ufl.edu

Principal Investigator:

Joel E Bialosky, PhD

More Information

Sponsor

University of Florida

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-01-12.