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

NCT00553540 | Completed Results DMC

• 1 other identifier: IOI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

backache; low backpain; sciatica

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Device: Back supports

Interventions

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.

Also known as: Moller Back Support System

Test Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland Clinic Florida: lead
• Integral Orthopedics Inc.: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (11)

• 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.

  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.

  PMID: 8588168 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.

  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.

  PMID: 7709270 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.

  PMID: 8148683 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.

  PMID: 9112706 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.

  PMID: 10024120 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.

  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.

  PMID: 10209800 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.

  PMID: 9322325 BACKGROUND

• 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.

  PMID: 21686825 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain; Sciatica

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Results Point of Contact

• Title: Dr. David Westerdahl
• Organization: Cleveland Clinic Florida

westerd@ccf.org

954-659-5422

Study Officials

• Vinod K Podichetty, MD,MS

  Cleveland Clinic Florida

  STUDY DIRECTOR

• David Westerdahl, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: October 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 25, 2019
• Results First Posted: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)