Clinical trial NCT01940744: Prescriptive Mobilization Versus a Pragmatic Mobilization
Official title: The Investigation of a Prescriptively Prescribed Non-Thrust Manipulation Versus a Pragmatically Prescribed Non-Thrust Manipulation for Treatment of Individuals With Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Low back pain
Non-specific Low back pain
Lead sponsor: Walsh University
Sponsor class: OTHER
Collaborators: name: Des Moines University
name: Youngstown State University
First posted: 2013-09-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: Multiple points, up to 6 months
Secondary outcomes:
measure: The Patient Acceptable Symptom State (PASS)
timeFrame: Multiple points up to 6 months
measure: Numeric Pain Rating Scale
timeFrame: Multiple points up to 6 months
measure: Global Rating of Change (GRoC)
timeFrame: Multiple points up to 6 months
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Des Moines University
state: Iowa
city: North Canton
country: United States
facility: Walsh University
state: Ohio
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Walsh University
name: Chad Cook, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donaldson M, Petersen S, Cook C, Learman K. A Prescriptively Selected Nonthrust Manipulation Versus a Therapist-Selected Nonthrust Manipulation for Treatment of Individuals With Low Back Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Apr;46(4):243-50. doi: 10.2519/jospt.2016.6318. Epub 2016 Mar 8.