Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

University of Florida1 site in 1 country20 target enrollmentSeptember 2015

ConditionsLow Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: University of Florida
Enrollment: 20
Locations: 1
Primary Endpoint: numeric pain rating scale
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

June 14, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
•Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
•Appropriate for conservative treatment for low back pain.

Exclusion Criteria

•Non-English speaking;
•Systemic medical conditions know to affect sensation (e.g. diabetes);
•History of lumbar surgery or fracture within the past 6 months;
•Received spinal manipulative therapy for treatment of low back pain within past 6 months;
•Current or history of chronic pain condition other than low back pain

Outcomes

Primary Outcomes

numeric pain rating scale

Time Frame: Change in baseline at 2 weeks

0 to 100 with 0= no pain at all to 100= worst pain imaginable

Secondary Outcomes

North American Spine Society Lumbar Spine Outcome Assessment(2 weeks)
Oswestry Disability Index(Change in baseline at 2 weeks)
Back Performance Scale(Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks)
Patient Centered Outcome Questionnaire(change in baseline immediately following spinal manipulative therapy during day 1)
Quantitative Sensory Testing(change in baseline immediately following spinal manipulative therapy during day 1)
Working alliance subscale of the Pain Rehabilitation Expectation Scale(change in baseline immediately following spinal manipulative therapy during day 1)
Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale(2 weeks)