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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553540
• Other study ID #: IOI
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: November 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cleveland Clinic Florida	Integral Orthopedics Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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.

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.

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. — View 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. — View Citation

Deyo RA, Phillips WR. Low back pain. A primary care challenge. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2826-32. Review. — View 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.

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. — View 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. — View Citation

Murphy PL, Volinn E. Is occupational low back pain on the rise? Spine (Phila Pa 1976). 1999 Apr 1;24(7):691-7. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months