Perspectives on Spinal Manipulative Therapy for Low Back Pain

NCT ID: NCT06590116

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2027-03-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

Patients seeking physical therapy for low back pain

Group Type: OTHER

Physical therapy

Intervention Type: OTHER

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

Physical therapists

Physical therapists treating enrolled patients

Group Type: OTHER

Physical therapist provider

Intervention Type: OTHER

Physical therapists will provide a combination of education, spinal manipulative therapy, and exercise to their patients with low back pain participating in the study

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

Intervention Type: 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

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooks Rehabilitation

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Joel E Bialosky, PhD

Role: primary

bialosky@phhp.ufl.edu

352-733-1162

References

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.

Reference Type: DERIVED

PMID: 40645636 (View on PubMed)

Other Identifiers

IRB202301700

Identifier Type: -

Identifier Source: org_study_id