Back to resultsPrescriptive Mobilization Versus a Pragmatic Mobilization
Primary Purpose
Mechanical Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescriptive Mobilization
Pragmatic Mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring Low back pain, Non-specific Low back pain
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.
Sites / Locations
- Des Moines University
- Walsh UniversityRecruiting
- Youngstown State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prescriptive Mobilization
Pragmatic Mobilization
Arm Description
The prescriptively applied non-thrust manipulation will be involve a central lumbar posterior-anterior directed at L4 and L5. "The therapist will place the hypothenar eminence of 1 hand over the spinous process of L4. With the elbows remaining extended, the therapist will deliver a low-velocity, high amplitude oscillatory force (at approximately 2 Hz) directed at L4 for a total 60 seconds (Figure 1)". Following a 30-second rest the therapist will perform a similar set of oscillations directed at L5. A second set of oscillations will then be performed in a similar manner at L4 and L5. Patients will be seen for 4 visits.
The pragmatically applied non-thrust manipulation will be based on the original concepts outlined by Maitland and will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits.
Outcomes
Primary Outcome Measures
Modified Oswestry Disability Index
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
The Patient Acceptable Symptom State (PASS)
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
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)
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.
Full Information
NCT ID
NCT01940744
First Posted
September 9, 2013
Last Updated
November 8, 2013
Sponsor
Walsh University
Collaborators
Des Moines University, Youngstown State University
1. Study Identification
Unique Protocol Identification Number
NCT01940744
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walsh University
Collaborators
Des Moines University, Youngstown State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
Low back pain, Non-specific Low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prescriptive Mobilization
Arm Type
Experimental
Arm Description
The prescriptively applied non-thrust manipulation will be involve a central lumbar posterior-anterior directed at L4 and L5. "The therapist will place the hypothenar eminence of 1 hand over the spinous process of L4. With the elbows remaining extended, the therapist will deliver a low-velocity, high amplitude oscillatory force (at approximately 2 Hz) directed at L4 for a total 60 seconds (Figure 1)". Following a 30-second rest the therapist will perform a similar set of oscillations directed at L5. A second set of oscillations will then be performed in a similar manner at L4 and L5. Patients will be seen for 4 visits.
Arm Title
Pragmatic Mobilization
Arm Type
Active Comparator
Arm Description
The pragmatically applied non-thrust manipulation will be based on the original concepts outlined by Maitland and will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits.
Intervention Type
Procedure
Intervention Name(s)
Prescriptive Mobilization
Other Intervention Name(s)
Non-thrust manipulation
Intervention Description
The therapist will place the hypothenar eminence of 1 hand over the spinous process of L4. With the elbows remaining extended, the therapist will deliver a low-velocity, high amplitude oscillatory force (at approximately 2 Hz) directed at L4 for a total 60 seconds (Figure 1)". Following a 30-second rest the therapist will perform a similar set of oscillations directed at L5. A second set of oscillations will then be performed in a similar manner at L4 and L5. Although not described in the original article, we'll target Grade III mobilizations. The procedure will be completed during a session after 2 sets of 60 seconds of non-thrust oscillatory manipulations will be performed over L4 and L5." Patients will be seen for 4 visits.
Intervention Type
Procedure
Intervention Name(s)
Pragmatic Mobilization
Other Intervention Name(s)
Non-thrust manipulation (pragmatically applied)
Intervention Description
The techniques will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Common techniques used may include unilateral posterior-anterior movements, central posterior-anterior movements, and sidelying rotations (without thrust). Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits.
Primary Outcome Measure Information:
Title
Modified Oswestry Disability Index
Description
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
Time Frame
Multiple points, up to 6 months
Secondary Outcome Measure Information:
Title
The Patient Acceptable Symptom State (PASS)
Description
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.
Time Frame
Multiple points up to 6 months
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
Multiple points up to 6 months
Title
Global Rating of Change (GRoC)
Description
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.
Time Frame
Multiple points up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad Cook, PhD, PT
Organizational Affiliation
Walsh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Des Moines University
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50312
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Petersen, ScD, PT
Phone
515-271-1688
Email
Shannon.Petersen@dmu.edu
First Name & Middle Initial & Last Name & Degree
Shannon Petersen, ScD, PT
Facility Name
Walsh University
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad E Cook, PhD, PT
Phone
330-490-7370
Email
ccook@walsh.edu
First Name & Middle Initial & Last Name & Degree
Chad E Cook, PhD, PT
First Name & Middle Initial & Last Name & Degree
Megan Donaldson, PhD, PT
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44555
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Learman, PhD, PT
Phone
330-261-7376
Email
klearman@ysu.edu
First Name & Middle Initial & Last Name & Degree
Ken Learman, PhD, PT
12. IPD Sharing Statement
Citations:
PubMed Identifier
26954273
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.
Results Reference
derived
Learn more about this trial
Prescriptive Mobilization Versus a Pragmatic Mobilization
We'll reach out to this number within 24 hrs