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| ID | Type | Description | Link |
|---|---|---|---|
| K24AT002422 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Osteopathic Heritage Foundations | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.
The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. This study uses a 2X2 factorial design to test the hypotheses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Active OMT and active (UST) | Other | Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy |
|
| B (Sham OMT and active UST) | Other | Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy |
|
| C (Active OMT and sham UST) | Other | Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy |
|
| D (Sham OMT and sham UST) | Other | Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A. Active OMT and active UST | Procedure | Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT) | Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%). | 12 weeks |
| Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST) | Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | 4 weeks |
| Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C. Licciardone, DO, MS, MBA | The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Osteopathic Research Center | Fort Worth | Texas | 76107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16080794 | Background | Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43. | |
| 18439282 | Background | Licciardone JC, King HH, Hensel KL, Williams DG. OSTEOPAThic Health outcomes in chronic low back pain: The OSTEOPATHIC Trial. Osteopath Med Prim Care. 2008 Apr 25;2:5. doi: 10.1186/1750-4732-2-5. |
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Participants were randomized after their study eligibility was confirmed by both telephonic and clinical screening examinations.
A total of 455 participants were recruited from the Dallas-Fort Worth, Texas metroplex from August 2006 to September 2010 through newspaper advertisements, community agencies, and medical clinics, excluding OMT specialty clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | OMT + UST | Active osteopathic manipulation and active ultrasound physical therapy |
| FG001 | Sham OMT + UST | Sham osteopathic manipulation and active ultrasound physical therapy |
| FG002 | OMT + Sham UST | Active osteopathic manipulation and sham ultrasound physical therapy |
| FG003 | Sham OMT + Sham UST | Sham osteopathic manipulation and sham ultrasound physical therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OMT + UST | Active osteopathic manipulation and active ultrasound physical therapy |
| BG001 | Sham OMT + UST | Sham osteopathic manipulation and active ultrasound physical therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT) | Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%). | Posted | Number | participants | 12 weeks |
|
12 weeks
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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 | OMT + UST | Active osteopathic manipulation and active ultrasound therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any serious adverse event according to Food and Drug Administration definition | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any other adverse event | General disorders | Systematic Assessment |
Co-morbid conditions, work disability and low back pain co-treatments were self reported by participants, but were not verified through medical or employment records. Missing data were imputed for 13% of participants at the final encounter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John C. Licciardone, DO, MS, MBA | University of North Texas Health Science Center-The Osteopathic Research Center | 817-735-2028 | john.licciardone@unthsc.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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| B. Sham OMT and active UST | Procedure | Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST) |
|
| C. Active OMT and sham UST | Procedure | Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST) |
|
| D. Sham OMT and sham UST | Procedure | Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST) |
|
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. |
| 8 weeks |
| Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | 12 weeks |
| Roland Morris Disability Questionnaire (UST and Sham UST - Week 4) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | 4 weeks |
| Roland Morris Disability Questionnaire (UST and Sham UST - Week 8) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | 8 weeks |
| Roland Morris Disability Questionnaire (UST and Sham UST - Week 12) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | 12 weeks |
| Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | 4 weeks |
| Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | 8 weeks |
| Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | 12 weeks |
| Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | 4 Weeks |
| Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | 8 Weeks |
| Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | 12 Weeks |
| Work Disability (OMT and Sham OMT - Week 4) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | 4 weeks |
| Work Disability (OMT and Sham OMT - Week 8) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | 8 weeks |
| Work Disability (OMT and Sham OMT - Week 12) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | 12 weeks |
| Work Disability (UST and Sham UST - Week 4) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | 4 weeks |
| Work Disability (UST and Sham UST - Week 8) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | 8 weeks |
| Work Disability (UST and Sham UST - Week 12) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | 12 weeks |
| Satisfaction With Back Care (OMT and Sham OMT - Week 4) | Subjects who reported being very satisfied with back care | 4 weeks |
| Satisfaction With Back Care (OMT and Sham OMT - Week 8) | Subjects who reported being very satisfied with back care | 8 weeks |
| Satisfaction With Back Care (OMT and Sham OMT - Week 12) | Subjects who reported being very satisfied with back care | 12 weeks |
| Satisfaction With Back Care (UST and Sham UST - Week 4) | Subjects who reported being very satisfied with back care | 4 weeks |
| Satisfaction With Back Care (UST and Sham UST - Week 8) | Subjects who reported being very satisfied with back care | 8 weeks |
| Satisfaction With Back Care (UST and Sham UST - Week 12) | Subjects who reported being very satisfied with back care | 12 weeks |
| 21135197 | Background | Clinical Guideline Subcommittee on Low Back Pain; American Osteopathic Association. American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back pain. J Am Osteopath Assoc. 2010 Nov;110(11):653-66. |
| 24590092 | Background | Licciardone JC, Gatchel R, Dagenais S. Assessment and management of back pain. JAMA Intern Med. 2014 Mar;174(3):478-9. doi: 10.1001/jamainternmed.2013.13692. No abstract available. |
| 24133757 | Background | Licciardone JC. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: an illustration of osteopathic semantic confusion. Author reply. J Am Osteopath Assoc. 2013 Sep;113(9):661-2. doi: 10.7556/jaoa.2013.031. No abstract available. |
| 23294676 | Background | Licciardone JC. Systematic review and meta-analysis conclusions relating to osteopathic manipulative treatment for low back pain remain valid and well accepted. J Bodyw Mov Ther. 2013 Jan;17(1):2-4. doi: 10.1016/j.jbmt.2012.10.003. Epub 2012 Nov 16. No abstract available. |
| 21494808 | Background | Licciardone JC. Osteopathic manipulative treatment in patients with low back pain. Clin Rheumatol. 2011 Jun;30(6):871-2; author reply 873. doi: 10.1007/s10067-011-1739-9. Epub 2011 Apr 15. No abstract available. |
| 23759340 | Result | Licciardone JC, Kearns CM, Minotti DE. Outcomes of osteopathic manual treatment for chronic low back pain according to baseline pain severity: results from the OSTEOPATHIC Trial. Man Ther. 2013 Dec;18(6):533-40. doi: 10.1016/j.math.2013.05.006. Epub 2013 Jun 10. |
| 23739758 | Result | Licciardone JC, Kearns CM, Hodge LM, Minotti DE. Osteopathic manual treatment in patients with diabetes mellitus and comorbid chronic low back pain: subgroup results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2013 Jun;113(6):468-78. |
| 23508598 | Result | Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):122-9. doi: 10.1370/afm.1468. |
| 23212429 | Result | Licciardone JC, Gatchel RJ, Kearns CM, Minotti DE. Depression, somatization, and somatic dysfunction in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Dec;112(12):783-91. |
| 22984233 | Result | Licciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596. |
| 22802542 | Result | Licciardone JC, Kearns CM. Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Jul;112(7):420-8. |
| 24361999 | Result | Licciardone JC. Short-term dosing of manual therapies for chronic low back pain. Spine J. 2014 Jun 1;14(6):1085-6. doi: 10.1016/j.spinee.2013.12.015. Epub 2013 Dec 20. No abstract available. |
| 24704126 | Result | Licciardone JC, Kearns CM, Crow WT. Changes in biomechanical dysfunction and low back pain reduction with osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Aug;19(4):324-30. doi: 10.1016/j.math.2014.03.004. Epub 2014 Mar 18. |
| 25002440 | Result | Licciardone JC. The OSTEOPATHIC trial demonstrates significant improvement in patients with chronic low back pain as manifested by decreased prescription rescue medication use. J Am Osteopath Assoc. 2014 Jul;114(7):528-9. doi: 10.7556/jaoa.2014.103. No abstract available. |
| 24965494 | Result | Licciardone JC, Aryal S. Clinical response and relapse in patients with chronic low back pain following osteopathic manual treatment: results from the OSTEOPATHIC Trial. Man Ther. 2014 Dec;19(6):541-8. doi: 10.1016/j.math.2014.05.012. Epub 2014 Jun 5. |
| 26927909 | Derived | Licciardone JC, Gatchel RJ, Aryal S. Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):156-68. doi: 10.7556/jaoa.2016.032. |
| 26927908 | Derived | Licciardone JC, Gatchel RJ, Aryal S. Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):144-55. doi: 10.7556/jaoa.2016.031. |
| BG002 | OMT + Sham UST | Active osteopathic manipulation and sham ultrasound physical therapy |
| BG003 | Sham OMT + Sham UST | Sham osteopathic manipulation and sham ultrasound physical therapy |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Active OMT |
Active osteopathic manipulation |
| OG001 | Sham OMT | Sham osteopathic manipulation |
|
|
|
| Secondary | Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | Week 4 Data | Posted | Median | Inter-Quartile Range | RMDQ Scale | 4 weeks |
|
|
|
| Secondary | Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | Week 8 Data | Posted | Median | Inter-Quartile Range | RMDQ Scale | 8 weeks |
|
|
|
| Secondary | Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | Week 12 Data | Posted | Median | Inter-Quartile Range | RMDQ Scale | 12 weeks |
|
|
|
| Secondary | Roland Morris Disability Questionnaire (UST and Sham UST - Week 4) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | Week 4 Data | Posted | Median | Inter-Quartile Range | RMDQ Scale | 4 weeks |
|
|
|
| Primary | Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST) | Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%). | Posted | Number | participants | 12 weeks |
|
|
|
|
| Secondary | Roland Morris Disability Questionnaire (UST and Sham UST - Week 8) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | Week 8 Data | Posted | Median | Inter-Quartile Range | RMDQ Scale | 8 weeks |
|
|
|
| Secondary | Roland Morris Disability Questionnaire (UST and Sham UST - Week 12) | Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning. | Week 12 Data | Posted | Median | Inter-Quartile Range | RMDQ Scale | 12 weeks |
|
|
|
| Secondary | Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | Posted | Median | Inter-Quartile Range | SF-36 General Health Score | 4 weeks |
|
|
|
| Secondary | Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | Posted | Median | Inter-Quartile Range | SF-36 General Health Score | 8 weeks |
|
|
|
| Secondary | Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | Posted | Median | Inter-Quartile Range | SF-36 General Health Score | 12 weeks |
|
|
|
| Secondary | Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | Posted | Median | Inter-Quartile Range | SF-36 General Health Score | 4 Weeks |
|
|
|
| Secondary | Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | Posted | Median | Inter-Quartile Range | SF-36 General Health Score | 8 Weeks |
|
|
|
| Secondary | Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12) | The general health scale ranges from 0 to 100, with higher scores representing better general health. | Posted | Median | Inter-Quartile Range | SF-36 General Health Score | 12 Weeks |
|
|
|
| Secondary | Work Disability (OMT and Sham OMT - Week 4) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | Lost 1 or more days of work in past 4 weeks because of low back pain. | Posted | Number | 95% Confidence Interval | Participants who reported lost work days | 4 weeks |
|
|
|
| Secondary | Work Disability (OMT and Sham OMT - Week 8) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | Lost 1 or more days of work in past 4 weeks because of low back pain. | Posted | Number | 95% Confidence Interval | Participants who reported lost work days | 8 weeks |
|
|
|
| Secondary | Work Disability (OMT and Sham OMT - Week 12) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | Lost 1 or more days of work in past 4 weeks because of low back pain. | Posted | Number | 95% Confidence Interval | Participants who reported lost work days | 12 weeks |
|
|
|
| Secondary | Work Disability (UST and Sham UST - Week 4) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | Lost 1 or more days of work in past 4 weeks because of low back pain. | Posted | Number | 95% Confidence Interval | Participants who reported lost work days | 4 weeks |
|
|
|
| Secondary | Work Disability (UST and Sham UST - Week 8) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | Lost 1 or more days of work in past 4 weeks because of low back pain. | Posted | Number | 95% Confidence Interval | Participants who reported lost work days | 8 weeks |
|
|
|
| Secondary | Work Disability (UST and Sham UST - Week 12) | Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain. | Lost 1 or more days of work in past 4 weeks because of low back pain. | Posted | Number | 95% Confidence Interval | Participants who reported lost work days | 12 weeks |
|
|
|
| Secondary | Satisfaction With Back Care (OMT and Sham OMT - Week 4) | Subjects who reported being very satisfied with back care | Posted | Number | 95% Confidence Interval | participants | 4 weeks |
|
|
|
| Secondary | Satisfaction With Back Care (OMT and Sham OMT - Week 8) | Subjects who reported being very satisfied with back care | Posted | Number | 95% Confidence Interval | participants | 8 weeks |
|
|
|
| Secondary | Satisfaction With Back Care (OMT and Sham OMT - Week 12) | Subjects who reported being very satisfied with back care | Posted | Number | 95% Confidence Interval | participants | 12 weeks |
|
|
|
| Secondary | Satisfaction With Back Care (UST and Sham UST - Week 4) | Subjects who reported being very satisfied with back care | Posted | Number | 95% Confidence Interval | participants | 4 weeks |
|
|
|
| Secondary | Satisfaction With Back Care (UST and Sham UST - Week 8) | Subjects who reported being very satisfied with back care | Posted | Number | 95% Confidence Interval | participants | 8 weeks |
|
|
|
| Secondary | Satisfaction With Back Care (UST and Sham UST - Week 12) | Subjects who reported being very satisfied with back care | Posted | Number | 95% Confidence Interval | participants | 12 weeks |
|
|
|
| 1 |
| 115 |
| 6 |
| 115 |
| EG001 | Sham OMT + UST | Sham osteopathic manipulation and active ultrasound therapy | 2 | 118 | 5 | 118 |
| EG002 | OMT + Sham UST | Active osteopathic manipulation and sham ultrasound therapy | 5 | 115 | 4 | 115 |
| EG003 | Sham OMT + Sham UST | Sham osteopathic manipulation and sham ultrasound therapy | 1 | 107 | 3 | 107 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |