Perspectives on Spinal Manipulative Therapy for Low Back Pain

NCT06590116 | Recruiting

• 1 other identifier: IRB202301700
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• PROMIS-29

  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.

  Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks

• NIH Chronic LBP Impact Score

  Combines results of the Pain Intensity, Physical Function, and Pain Interference PROMIS scores. Scores range from 8 (least impact) to 50 (greatest impact).

  12 weeks and 26 weeks

Secondary Outcomes (1)

• Patient Acceptable Symptom State

  Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks

Study Arms (2)

Patients

OTHER

Patients seeking physical therapy for low back pain

Other: Physical therapy

Physical therapists

OTHER

Physical therapists treating enrolled patients

Other: Physical therapist provider

Interventions

Physical therapy OTHER

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

Patients

Physical therapist provider 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

Physical therapists

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Florida: lead
• Brooks Rehabilitation: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)