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NCT Number: NCT06590116

Perspectives on Spinal Manipulative Therapy for Low Back Pain

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Joel E Bialosky, PhD

CONTACT

[email protected]

352-733-1162

Joel E Bialosky, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

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

Primary outcomes

  1. PROMIS-29

    Time frame: 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.

  2. NIH Chronic LBP Impact Score

    Time frame: 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 outcomes

  1. Patient Acceptable Symptom State

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Brooks Rehabilitation

Registry information

Official study title

Patient and Physical Therapist Perspectives on Spinal Manipulative Therapy for Low Back Pain

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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