Perspectives on Spinal Manipulative Therapy for Low Back Pain

Not Applicable

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06590116
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-12-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States