Perspectives on Spinal Manipulative Therapy for Low Back Pain

Patient and Physical Therapist 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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Physical therapy; Other: Physical therapist provider

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Joel E Bialosky, PhD
      • Contact: Joel E Bialosky, PhD; Phone Number: 352-733-1162; Email: bialosky@phhp.ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients; Patients seeking physical therapy for low back pain	Other: Physical therapy; Patients with low back pain will receive a combination of education, spinal manipulative therapy, and exercise as prescribed by their physical therapist
Other: Physical therapists; Physical therapists treating enrolled patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Back Pain Treatment Beliefs Questionnaire	Assesses perceived credibility, effectiveness, concerns, and individual fit for treatments including medication, exercise, spinal manipulation, spinal mobilization, and massage. Both participating patients and physical therapists will complete this questionnaire.	Baseline and 2 weeks
The Credibility Expectancy Questionnaire	The Credibility Expectancy Questionnaire will assess credibility and expectancy of SMT in terms of three items related to credibility (how logical therapy offered seems) and three items related to expectancy (expectations for treatment to reduce symptoms). Both participating patients and physical therapists will complete the Credibility Expectancy Questionnaire.	Baseline and 2 weeks
The Back Pain Attitudes Questionnaire	This will assess the beliefs about low back pain of participating patients and their physical therapists	Baseline and 2 weeks (patients); Baseline only (physical therapists)
The Optimal Screening for Prediction of Referral and Outcome Yellow Flag Tool	A multidimensional tool used for assessment of pain-related psychological characteristics for people with musculoskeletal pain conditions. The OSPRO-YF evaluates discrete pain-related psychological characteristics across 3 constructs: (1) negative mood (anxiety, depression, and anger); (2) fear-avoidance (pain catastrophizing, fear avoidance (work and physical activity), pain anxiety, and kinesiophobia); and (3) positive affect/coping (pain self-efficacy, self-efficacy for rehabilitation, and pain acceptance). Only participating patients will complete this questionnaire.	Baseline and 2 weeks and 6 weeks and 12 weeks
The Working Alliance Inventory Short Revised Therapist Versions	Assesses therapeutic alliance from the physical therapist perspective. Only participating physical therapists will complete this assessment.	2 weeks and 6 weeks
The Working Alliance Inventory Short Revised Client Versions	Assesses therapeutic alliance from the patientt perspective. Only participating patients will complete this assessment.	2 weeks and 6 weeks
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.	Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Brooks Rehabilitation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: IRB202301700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No