Perspectives on Spinal Manipulative Therapy for Low Back Pain

University of Florida90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low Back Pain

Interventions

Physical therapyOTHER

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

Physical therapist providerOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.)

Locations (1)

University of Florida

Gainesville, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 12 weeks and 26 weeks

Secondary Outcomes

Patient Acceptable Symptom State

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.

Time frame: Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks

Data from ClinicalTrials.gov

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