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| Name | Class |
|---|---|
| Integral Orthopedics Inc. | INDUSTRY |
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The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.
Back pain is a common and expensive medical condition. Although rarely life-threatening, back disorders are a major cause of pain, disability, and social cost affecting the quality of life in most patients. Although primary care providers routinely treat back pain, little is known about how often primary care providers manage occupation-related symptoms and how outcomes compare with other treatment modalities. Treatment outcomes utilizing a non-operative treatment paradigm have not been adequately studied. This paradigm consists of treating patients sequentially with analgesics, physical therapy, use of back supports, caudal epidural steroid injections, or surgical referral. The use of spinal supports as a complimentary treatment along with physical therapy and posture education is promising.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients in this group will receive physical therapy and posture education for low back pain | |
| Test Group | Active Comparator | Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Back supports | Device | The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low Back Pain | numeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24. Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinod K Podichetty, MD,MS | Cleveland Clinic Florida | Study Director |
| David Westerdahl, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Andersson GBJ. The epidemiology of spinal disorders. In: Frymoyer JW, Ducker TB, Hadler NM, et al, eds. The Adult Spine: Principles and Practice. Philadelphia: Lippincott-Raven, 1997:93-141. | ||
| 8588168 | Background | Leboeuf-Yde C, Lauritsen JM. The prevalence of low back pain in the literature. A structured review of 26 Nordic studies from 1954 to 1993. Spine (Phila Pa 1976). 1995 Oct 1;20(19):2112-8. doi: 10.1097/00007632-199510000-00009. | |
| Background | Frymoyer JW, Durett CL. The economics of spinal disorders. In: Frymoyer JW, Ducker TB, Hadler NM, et al, eds. The Adult Spine: Principles and Practice. Philadelphia: Lippincott-Raven, 1997:143-150. | ||
| 7709270 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Patients in this group will receive physical therapy and posture education for low back pain |
| FG001 | Test Group | Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 43 participants for whom baseline characteristics were measured.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Patients in this group will receive physical therapy and posture education for low back pain |
| BG001 | Test Group | Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We did not have the age for several participants and were regarded as missing values when running the data in SPSS |
| 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 Low Back Pain | numeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24. Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24. | Posted | Mean | Full Range | units on a scale | 6 months |
|
adverse events were not monitored or assessed
adverse events were not monitored or assessed
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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 | Control Group | Patients in this group will receive physical therapy and posture education for low back pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Westerdahl | Cleveland Clinic Florida | 954-659-5422 | 5422 | westerd@ccf.org |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Background |
| Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine (Phila Pa 1976). 1995 Jan 1;20(1):11-9. doi: 10.1097/00007632-199501000-00003. |
| 8148683 | Background | Coste J, Delecoeuillerie G, Cohen de Lara A, Le Parc JM, Paolaggi JB. Clinical course and prognostic factors in acute low back pain: an inception cohort study in primary care practice. BMJ. 1994 Feb 26;308(6928):577-80. doi: 10.1136/bmj.308.6928.577. |
| 9112706 | Background | Deyo RA, Phillips WR. Low back pain. A primary care challenge. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2826-32. doi: 10.1097/00007632-199612150-00003. |
| 10024120 | Background | Carey TS, Garrett JM, Jackman A, Hadler N. Recurrence and care seeking after acute back pain: results of a long-term follow-up study. North Carolina Back Pain Project. Med Care. 1999 Feb;37(2):157-64. doi: 10.1097/00005650-199902000-00006. |
| Background | Bernard BP. Introduction. In: Bernard BP, ed. Musculoskeletal Disorders and Workplace Factors. Cincinnati: National Institute for Occupational Safety and Health, Centers for Disease Control, U.S. Department of Health and Human Services, 1997. |
| 10209800 | Background | Murphy PL, Volinn E. Is occupational low back pain on the rise? Spine (Phila Pa 1976). 1999 Apr 1;24(7):691-7. doi: 10.1097/00007632-199904010-00015. |
| 9322325 | Background | van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine (Phila Pa 1976). 1997 Sep 15;22(18):2128-56. doi: 10.1097/00007632-199709150-00012. |
| 21686825 | Derived | Podichetty VK, Varley ES. Spinal supports and physical therapy in patients with low back pain: a case series. BMJ Case Rep. 2009;2009:bcr07.2008.0405. doi: 10.1136/bcr.07.2008.0405. Epub 2009 Apr 23. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data | Count of Participants | Participants |
|
| Body Mass Index | The analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data | Mean | Standard Deviation | kg/m^2 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Test Group | Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |