- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01940744
Prescriptive Mobilization Versus a Pragmatic Mobilization
November 8, 2013 updated by: Chad Cook, Walsh University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Iowa
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Des Moines, Iowa, United States, 50312
- Not yet recruiting
- Des Moines University
-
Contact:
- Shannon Petersen, ScD, PT
- Phone Number: 515-271-1688
- Email: Shannon.Petersen@dmu.edu
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Sub-Investigator:
- Shannon Petersen, ScD, PT
-
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Ohio
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North Canton, Ohio, United States, 44720
- Recruiting
- Walsh University
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Contact:
- Chad E Cook, PhD, PT
- Phone Number: 330-490-7370
- Email: ccook@walsh.edu
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Principal Investigator:
- Chad E Cook, PhD, PT
-
Sub-Investigator:
- Megan Donaldson, PhD, PT
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Youngstown, Ohio, United States, 44555
- Not yet recruiting
- Youngstown State University
-
Contact:
- Ken Learman, PhD, PT
- Phone Number: 330-261-7376
- Email: klearman@ysu.edu
-
Sub-Investigator:
- Ken Learman, PhD, PT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Prescriptive Mobilization
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 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.
Other Names:
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ACTIVE_COMPARATOR: Pragmatic Mobilization
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Oswestry Disability Index
Time Frame: 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
|
Multiple points, up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Patient Acceptable Symptom State (PASS)
Time Frame: 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.
|
Multiple points up to 6 months
|
Numeric Pain Rating Scale
Time Frame: 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.
|
Multiple points up to 6 months
|
Global Rating of Change (GRoC)
Time Frame: 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.
|
Multiple points up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chad Cook, PhD, PT, Walsh University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ANTICIPATED)
October 1, 2014
Study Completion (ANTICIPATED)
December 1, 2014
Study Registration Dates
First Submitted
September 9, 2013
First Submitted That Met QC Criteria
September 11, 2013
First Posted (ESTIMATE)
September 12, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 13, 2013
Last Update Submitted That Met QC Criteria
November 8, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Walsh992013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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