Thrust Manipulation Versus Non-Thrust Manipulation
Primary Purpose
Mechanical Low Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thrust manipulation
Non-thrust manipulation
Sponsored by

About this trial
This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring manipulation, mobilization, low back pain, treatment
Eligibility Criteria
Inclusion Criteria:
- Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.
- For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.
Exclusion Criteria:
- The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- 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
- Diminished or absent sensation to pinprick in any lower extremity dermatome)
- Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy
Sites / Locations
- Walsh University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thrust manipulation
Non-thrust manipulation
Arm Description
Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals
Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals
Outcomes
Primary Outcome Measures
Oswestry disability index
Change score
Secondary Outcome Measures
Numeric Pain Rating Scale (NPRS)
Change score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01438203
Brief Title
Thrust Manipulation Versus Non-Thrust Manipulation
Official Title
Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walsh University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.
Detailed Description
Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
manipulation, mobilization, low back pain, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thrust manipulation
Arm Type
Experimental
Arm Description
Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals
Arm Title
Non-thrust manipulation
Arm Type
Active Comparator
Arm Description
Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals
Intervention Type
Procedure
Intervention Name(s)
Thrust manipulation
Other Intervention Name(s)
Manipualtion (Manip)
Intervention Description
Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region
Intervention Type
Procedure
Intervention Name(s)
Non-thrust manipulation
Other Intervention Name(s)
Mobilization (Mob)
Intervention Description
Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
Change score
Time Frame
Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Change score
Time Frame
Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.
For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.
Exclusion Criteria:
The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
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
Diminished or absent sensation to pinprick in any lower extremity dermatome)
Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad E Cook, PhD
Organizational Affiliation
Walsh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walsh University
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22879443
Citation
Cook CE, Learman KE, O'Halloran BJ, Showalter CR, Kabbaz VJ, Goode AP, Wright AA. Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther. 2013 Jan;93(1):32-40. doi: 10.2522/ptj.20120216. Epub 2012 Aug 9.
Results Reference
derived
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Thrust Manipulation Versus Non-Thrust Manipulation
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