Prescriptive Mobilization Versus a Pragmatic Mobilization

Not Applicable

• Conditions: Mechanical Low Back Pain

• Registration Number: NCT01940744
• Lead Sponsor: Walsh University

Brief Summary

This study is designed to compare the outcomes of two types of manual therapy techniques on patients with low back pain. Both immediate- and long-term outcomes will be examined. The investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

Detailed Description

This randomized clinical trial is designed to compare the outcomes of a prescriptively applied non-thrust manipulation to a pragmatically applied non-thrust manipulation on subjects with mechanical low back pain. The study has two primary aims. Specific Aim 1 examines immediate effect differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. Specific Aim 2 examines longer-term differences between a pragmatically applied localized non-thrust manipulation versus a prescriptively applied, non-localized non-thrust manipulation in subjects with mechanical low back pain. The investigators hypothesize there will be no differences between the two applied treatment techniques in immediate and longer-term assessments.

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-12
• Study Start: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-13
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of >2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination.

Exclusion Criteria

• The presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Lastly, if patients are enrolled in the study but do not receive a second outcome measure (follow up visit) they will be excluded from the final analyses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified Oswestry Disability Index	Multiple points, up to 6 months	The Modified Oswestry Disability Index (ODI) will be used to measure disability, will serve as the primary outcome measure for the study, and consists of 10 questions each scored from 0 to 5, with higher scores indicating greater disability. A 50% reduction in the ODI or greater from baseline has been considered a clinically important outcome

Secondary Outcome Measures

Name	Time	Method
The Patient Acceptable Symptom State (PASS)	Multiple points up to 6 months	The PASS is the state beyond which patients consider their state as acceptable and are unlikely to seek further treatment. Thus, therapeutic success can be defined at the individual level (i.e., for each patient) as an improvement greater than minimum clinically acceptable score, or as achieving a state acceptable at the end of the care. For our study, recovery is defined as a "yes" (patients consider their state as acceptable) on the PASS at discharge.
Numeric Pain Rating Scale	Multiple points up to 6 months	An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Possible Pain". NPRSs have been shown to be reliable and valid. Patients rate their current level of pain and their worst and least amount of pain experienced during the last 24 hours.
Global Rating of Change (GRoC)	Multiple points up to 6 months	The fifteen-point global rating scale described by Jaeschke et al., will be used. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). The global rating scale will be administered at 4 visits, 1 month, and 6 months.

Trial Locations

Locations (3)

Des Moines University; 🇺🇸 Des Moines, Iowa, United States

Walsh University; 🇺🇸 North Canton, Ohio, United States

Youngstown State University; 🇺🇸 Youngstown, Ohio, United States