Low Back Pain
Conditions
Keywords
backache, low backpain, sciatica
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.
Interventions
DEVICEBack 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.
Sponsors
Integral Orthopedics Inc.
Cleveland Clinic Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low Back Pain | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Patients in this group will receive physical therapy and posture education for low back pain | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | discharged after first visit | 2 | 5 |
Baseline characteristics
| Characteristic | Control Group | Test Group | Total |
|---|---|---|---|
| Age, Continuous | 48.48 years STANDARD_DEVIATION 9.462 | 42.95 years STANDARD_DEVIATION 11.781 | 45.61 years STANDARD_DEVIATION 10.98 |
| Body Mass Index | 28.326 kg/m^2 STANDARD_DEVIATION 6.498 | 28.686 kg/m^2 STANDARD_DEVIATION 5.997 | 28.49 kg/m^2 STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group | Change in Low Back Pain | 2.58 units on a scale |
| Test Group | Change in Low Back Pain | 1.80 units on a scale |