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| Name | Class |
|---|---|
| Des Moines University | OTHER |
| Youngstown State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescriptive Mobilization | Experimental | 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. |
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| Pragmatic Mobilization | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescriptive Mobilization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Multiple points, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Cook, PhD, PT | Walsh University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Des Moines University | Not yet recruiting | Des Moines | Iowa | 50312 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26954273 | Derived | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Pragmatic Mobilization | Procedure | 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. |
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| Multiple points up to 6 months |
| 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. | Multiple points up to 6 months |
| 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. | Multiple points up to 6 months |
| Walsh University | Recruiting | North Canton | Ohio | 44720 | United States |
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| Youngstown State University | Not yet recruiting | Youngstown | Ohio | 44555 | United States |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |