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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00AT004196-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Manipulation | Experimental | Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. |
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| Mechanical Manipulation | Experimental | Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. |
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| Standard Medical Care | Active Comparator | Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Manipulation | Procedure | Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Low Back Pain Disability Index | The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment). | 4 weeks (post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Score. | Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating "no pain" and 10 indicating "unbearable pain". Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Schneider, PhD, DC | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center: Center for Integrative Medicine | Pittsburgh | Pennsylvania | 15232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20350672 | Background | Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. Mechanical vs manual manipulation for low back pain: an observational cohort study. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010. | |
| 36471334 | Derived | Tonelli Enrico V, Schneider M, Haas M, Vo N, Huang W, McFarland C, Weber N, Sowa G. The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1059. doi: 10.1186/s12891-022-06027-9. |
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197 patients were screened for potential eligibility. We excluded 85 patients for not meeting the inclusion criteria. Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.
We recruited 112 patients with a new episode of low back pain from the general population of the Greater Pittsburgh Metropolitan region. Recruitment took place during the period of time between November 2010 and April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Manipulation | Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. |
| FG001 | Mechanical Manipulation | Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants. |
| FG002 | Standard Medical Care | Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Manipulation | Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oswestry Low Back Pain Disability Index | The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks (post treatment) |
|
Adverse event data were collected at each treatment visit in each of the 3 treatment arms, over the course of the entire 4-week treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Manipulation | Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J Schneider, DC, PhD | University of Pittsburgh, Department of Physical Therapy' | 412-383-6640 | mjs5@pitt.edu |
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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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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Mechanically-assisted manipulation | Device | Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants. |
|
|
| Standard Medical Care | Other | Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. |
|
| 4 weeks (post treatment) |
| Mechanical Manipulation |
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants. |
| BG002 | Standard Medical Care | Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Mechanical Manipulation | Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants. |
| OG002 | Standard Medical Care | Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. |
|
|
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| Secondary | Numeric Pain Rating Score. | Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating "no pain" and 10 indicating "unbearable pain". Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks (post treatment) |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Mechanical Manipulation | Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument. Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants. | 0 | 35 | 0 | 35 |
| EG002 | Standard Medical Care | Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. | 0 | 35 | 0 | 35 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |