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Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Back supports
Sponsored by
Cleveland Clinic Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring backache, low backpain, sciatica

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients must present with clinical symptoms of low back pain and evaluated by the study physician
  • Visual Analog Score (VAS) for Pain >6 in response to the following question: Circle one number (from 0 = no pain to 10 = worst pain) "How would you rate the worst pain you experienced in last week."
  • Patients must have x-ray and or an MRI film for diagnostic evaluation based on physician judgment.
  • Age >18; both male and female
  • Pain duration >3 months

Exclusion Criteria:

  • Prior use of opioids, physical therapy, epidural injections for back pain or ongoing chiropractor care and or acupuncture treatment
  • Moderate to severe arthritis of the spine/ knee or hip that might severely compromise ambulation and or posture
  • Patients with diagnosed lumbar canal stenosis
  • Serious concomitant medical illness (i.e., heart disease)
  • Obese patients (twice the width of the Moller Orthopedic Back Support)
  • Patients with moderate to severe scoliosis
  • Past or present existence of a movement disorder, e.g., Parkinsonism, or any neurological disease that might affect ambulation and or postural changes History of osteoporosis
  • Severe psychiatric disorder
  • Prior spine surgery
  • Multiple vertebral compression fractures with kyphosis
  • Past or present workmen's compensation claim, SSI disability, or ongoing litigation

Sites / Locations

  • Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Test Group

Arm Description

Patients in this group will receive physical therapy and posture education for low back pain

Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2007
Last Updated
November 5, 2019
Sponsor
Cleveland Clinic Florida
Collaborators
Integral Orthopedics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00553540
Brief Title
Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Official Title
A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cleveland Clinic Florida
Collaborators
Integral Orthopedics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
backache, low backpain, sciatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in this group will receive physical therapy and posture education for low back pain
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain
Intervention Type
Device
Intervention Name(s)
Back supports
Other Intervention Name(s)
Moller Back Support System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Low Back Pain
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must present with clinical symptoms of low back pain and evaluated by the study physician Visual Analog Score (VAS) for Pain >6 in response to the following question: Circle one number (from 0 = no pain to 10 = worst pain) "How would you rate the worst pain you experienced in last week." Patients must have x-ray and or an MRI film for diagnostic evaluation based on physician judgment. Age >18; both male and female Pain duration >3 months Exclusion Criteria: Prior use of opioids, physical therapy, epidural injections for back pain or ongoing chiropractor care and or acupuncture treatment Moderate to severe arthritis of the spine/ knee or hip that might severely compromise ambulation and or posture Patients with diagnosed lumbar canal stenosis Serious concomitant medical illness (i.e., heart disease) Obese patients (twice the width of the Moller Orthopedic Back Support) Patients with moderate to severe scoliosis Past or present existence of a movement disorder, e.g., Parkinsonism, or any neurological disease that might affect ambulation and or postural changes History of osteoporosis Severe psychiatric disorder Prior spine surgery Multiple vertebral compression fractures with kyphosis Past or present workmen's compensation claim, SSI disability, or ongoing litigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinod K Podichetty, MD,MS
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Westerdahl, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
8588168
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
7709270
Citation
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.
Results Reference
background
PubMed Identifier
8148683
Citation
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.
Results Reference
background
PubMed Identifier
9112706
Citation
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.
Results Reference
background
PubMed Identifier
10024120
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
10209800
Citation
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.
Results Reference
background
PubMed Identifier
9322325
Citation
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.
Results Reference
background
PubMed Identifier
21686825
Citation
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.
Results Reference
derived

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Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

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